Sequana Medical receives certification under MDR, the new European Medical Device Regulation

Below, we are re-publishing with permission the press-release issued by Sequana Medical on February 14, 2022

  • alfapump® is one of the first novel Class III active implantable medical devices to be certified

Ghent, Belgium – 14 February 2022 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI), ensuring continuous market access of the alfapump system in the European Union (EU).

Sequana Medical was granted the EU Quality Management System (QMS) Certificate and the EU Technical Documentation Assessment Certificate confirming that the Company’s QMS and the alfapump system are compliant with the latest regulatory standards required for medical devices in Europe. The Company’s proprietary DirectLink technology built into the alfapump system has been classified as medical device under the MDR, clearly demonstrating the relevance and importance of alfapump performance data monitoring, allowing physicians to closer follow-up on their patients. This announcement follows the recent QMS certification under the Medical Device Single Audit Program (MDSAP), demonstrating Sequana Medical’s compliance to the high standards of medical device regulations internationally.

Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: Achieving MDR certification is another major milestone and the result of our early adaption to the new and more stringent regulatory requirements in Europe. This achievement would not have been possible without the extensive and diligent work of the entire Sequana Medical team. We are also very thankful for the longstanding relationship with BSI, our competent Notified Body, and we look forward to continuing working with them.”

Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “Without doubt, MDR has raised the standards for medical device regulation and we are excited to be one of the first novel Class III active implantable medical device companies to receive this certification. It shows our strong commitment to complying with the highest regulatory standards for medical devices and is a demonstration of our progress to meeting the standards required for approval of the alfapump in the U.S.”

About European Medical Device Regulation (MDR)

The MDR 2017/745 came into effect in May 2021, replacing the former European Directives for medical devices (AIMDD 90/385/EEC and MDD 93/42/EEC). It is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of safety and health whilst supporting innovation. MDR has significantly increased the requirements in respect of technical documentation, benefit-risk evaluation, Unique Device Identification (UDI), Economic Operators, clinical data and post-market surveillance, with more stringent scrutiny of Competent Authorities and Notified Bodies. It represents the biggest change in European medical device compliance standards in more than 20 years.

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Clinical Accelerator announces collaboration with Deerfield Catalyst, a medtech incubator committed to developing transformational solutions to improve patient outcomes and streamline care

Clinical Accelerator, a full-service, medical device focused contract research organization, is pleased to announce a collaboration with Deerfield Catalyst. The company combines the resources of two established health pioneers: Coridea, a New-York based, premier Medical Device Incubator; and Deerfield, an investment management firm focused on healthcare. The plan is to launch 10 companies over the next five years developing innovative medical devices.

Clinical Accelerator is excited to be joining this collaboration, offering our extensive expertise in management of medical device investigations with a special focus on early human feasibility studies. Our ability to accelerate the timelines of clinical studies and reduce the capital required, allows R&D programs to advance faster, bringing novel medical devices to patients earlier.

The first collaborative project with Deerfield Catalyst will be a pilot study for a novel device treating Obstructive Sleep Apnea and we look forward to many more studies in the future.

About Deerfield  

Deerfield Device Design and Development Catalyst (Deerfield Catalyst) is a medtech incubator that aims to support and advance transformational innovation into commercial products and successful enterprises. A collaboration between Deerfield and the Coridea team, Deerfield Catalyst is focused on developing medtech solutions that improve outcomes and streamline patient care. The incubator plans to launch 10 companies over the next five years. 

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.

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Clinical Accelerator announces collaboration with Verve Medical to conduct an early human feasibility study for treatment-resistant hypertension

Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Verve Medical, to conduct an early human feasibility study of their novel medical device for patients with treatment-resistant hypertension.

World-wide, there are over a billion patients who suffer from hypertension and it is directly responsible for millions of deaths annually. Many patients with hypertension are either inadequately identified or treated and medications can be expensive and have side effects. Verve Medical is focused on proving an effective peri-pelvic renal denervation approach to hypertension which, unlike the peri-arterial approach, avoids the possibility of arterial restenosis and does not require anticoagulation or antiplatelet agents. This device has the ability to achieve an immediate blood pressure drop in patients that is comparable to open sympathectomy.

Clinical Accelerator is very excited to partner in this project and will be working closely with Verve Medical, running their early human feasibility study in our region of operation. We look forward to developing this product and achieving positive data on this potentially life-changing device.

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging medtech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.

About Verve Medical

Verve Medical is an early-stage medical device company, based in the United States and focused on developing novel non-vascular renal denervation devices for treatment-resistant hypertension.

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ANTERIS REPORTS SUCCESSFUL INTERIM RESULTS FOR THE FIRST-IN-HUMAN TRIAL FOR DurAVR

Below, we are re-publishing with permission the press-release issued by Anteris Technologies Ltd on January 24, 2022

Brisbane, Australia and Minneapolis, USA, Anteris Technologies Ltd (ASX: AVR) reports the first-in-human DurAVR™ THV study met or exceeded its interim study objectives.
At the 30-day follow up point, the first five patients of the planned 10-patient study showed:

• All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention).
• An average 86% improvement in mean gradient (standard measure of stenosis severity) from pre-treatment levels.
• Mean gradients were up to 50% lower than other TAVR devices when matched to annular size.1 All patients are in the normal or near normal range when compared to the general population with normal valve function.
• Average Effective Orifice Area (EOA) was up to 45% larger than those reported with other TAVR devices in matched annular sizes.2
• No conduction (heart rhythm) disturbances due to the procedure.
• No clinically significant paravalvular regurgitation despite very complex and heavily calcified anatomy.
• Echocardiographic and CT analysis reported normal leaflet mobility, no leaflet calcification or thrombus generation.
• Echocardiographic and CT imaging data showed consistent laminar flow throughout the valve and long coaptation length in all five patients. Ostensibly, these features indicate lower leaflet strain leading to long term durability.
• The system also allowed for excellent commissural alignment; a significant patient benefit if future coronary intervention were required.
• A 20% increase from baseline in 6 min walk test (a measure of patient exercise tolerance). This is a 170% greater improvement than observed in studies of other TAVR valves.3 This indicates a marked improvement in patients’ functional status and exercise tolerance. The improvement in exercise capacity may be associated with the increased EOA (larger valve opening area due to its unique design) allowing optimal haemodynamics (blood flow) at rest and during exercise.4 Exercise performance is a critical marker of cardiac health.

Dr. Paul Sorajja, an interventional cardiologist at Abbott Northwestern Hospital and one of the implanting physicians in this trial commented, “Due to its unique leaflet design, DurAVR™ continues to provide superior haemodynamics with a balloon expandable platform”.

Dr. Vinnie Bapat, a cardiothoracic surgeon at the Minneapolis Heart Institute and another member of the team of implanting physicians in the trial stated, “DurAVR™ has been rationally engineered to provide ease of implantation of the valve for the doctor, immediate haemodynamic benefit for the patient post-implantation, and the potential to provide a long-term durable effect which is of utmost importance when treating younger, low-risk patients. We are happy to see the patients on this trial doing so well with such impressive haemodynamic improvement, and are looking forward to enrolling the rest of the trial imminently”.

“DurAVRTM continues to exceed very high expectations in a complex group of bicuspid and tricuspid patients. The haemodynamic performance as well as valve function is remarkable. Additionally, the lack of any conduction change (arrhythmia) across five patients is a testament to the engineering team’s ingenuity and focus on improving all aspects of TAVR for patients. All signs continue to point to success in our mission of making available a TAVR that works better from the get-go and lasts longer,” Anteris Chief Medical Officer, TAVR interventionalist Dr Chris Meduri (the study leader), commented.

“The excellent results observed so far are a function of the proprietary 3D single-piece leaflet design of DurAVR™ that mimics a native aortic valve. These numbers are even more remarkable considering this cohort had small annular anatomy. Furthermore, patients’ functional status improved as did their exercise performance indicating early improvements in quality-of-life due to receiving DurAVR™. As the mean age of patients in this study is 73 this improvement in exercise performance is incredibly important and supports the use of DurAVR™ in this more active patient group who require a valve that lasts longer and works better than current solutions. The current data represents a small number of patients and should be viewed as such. However, we look forward to continuing the study with the next cohort as well as recruiting patients for our FDA IDE study and reporting more results during 2022,” Anteris CEO Wayne Paterson said.

1Naidu et al. Measuring TAVR Prosthesis Gradient Immediately Post-Procedure May Underestimate its Significance. JACC CV Imag. 2021;15(1):120-121
2Hahn et al. Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function. JACC CV Imag.
2019;12(1):25-34)
3Mack et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients/Supplementary Appendix N Engl J Med 2019; 380:1695-1705
4Gorlin et al. Dynamics of the circulation in aortic valvular disease., Am J Med. 1955 Jun;18(6):855-70

ENDS

About Anteris Technologies Ltd (ASX: AVR)

Anteris Technologies Ltd is a structural heart company that delivers clinically superior and durable solutions through better science and better design.

Its focus is developing next-generation technologies that help healthcare professionals reproduce consistent life-changing outcomes for patients.

Anteris’ DurAVR™ 3D single-piece aortic heart valve replacement addresses the needs of tomorrow’s younger and more active aortic stenosis patients by delivering superior performance and durability through innovations designed to last the remainder of a patient’s lifetime.

The proven benefits of its patented ADAPT® tissue technology, paired with the unique design of our DurAVR™ 3D single-piece aortic heart valve, have the potential to deliver a game-changing treatment to aortic stenosis patients worldwide and provide a much-needed solution to the challenges facing doctors today.

Authorisation and Additional information

This announcement was authorised by Mr Wayne Paterson, Chief Executive Officer.

For more information:

Hannah Howlett WE Communications E: WE-AU AnterisTech@we-worldwide.com P: +61 4 5064 8064 http://www.anteristech.com Twitter: @AnterisTech Facebook: http://www.facebook.com/AnterisTech; Linkedin.com/company/anteristech

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Sequana Medical announces positive interim results of SAHARA DESERT, the alfapump DSR® study in heart failure patients with persistent congestion

Below, we are re-publishing with permission the press-release issued by Sequana Medical NV on December 07, 2021

The alfapump® system © SEQUANA MEDICAL NV
  • Interim data from six patients indicate that alfapump DSR therapy can:
    • safely, effectively and rapidly eliminate persistent congestion and restore euvolemia in diuretic-resistant heart failure patients,
    • considerably benefit cardio-renal status, and
    • dramatically improve diuretic responsiveness for months post-treatment
  • Recruitment on-track to report top-line data in H2 2022
  • Long-term follow-up of RED DESERT patients shows durable improvement in diuretic response following alfapump DSR therapy
  • Proprietary DSR Infusate 2.0 development on track to start MOJAVE DESERT in H2 2022

Ghent, Belgium – 7 December 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or Sequana Medical), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces positive interim results from six patients in SAHARA DESERT, the safety and feasibility study of alfapump DSR (Direct Sodium Removal) in heart failure patients with persistent congestion.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are extremely pleased with these interim results from SAHARA DESERT which, for the first time, indicate the ability of repeated DSR therapy to safely, effectively and rapidly eliminate persistent congestion in decompensated heart failure patients. Just as we showed in RED DESERT, we are able to achieve this, together with a major improvement in patients’ diuretic-response. It is promising to see the improved cardio-renal status of these patients compared to the status expected for patients undergoing volume removal. We look forward to the completion of enrolment to report on top-line data and the planned commencement of MOJAVE DESERT, our first U.S. DSR study, in H2 2022. The long-term follow-up data from our RED DESERT patients is very encouraging, indicating the sustained improvement in diuretic response as demonstrated by a clear reduction in the need for loop diuretics. This further indicates how powerful and versatile our alfapump DSR platform is and how it can address clear unmet medical needs within this large and growing patient population.”

Strong interim results from SAHARA DESERT

All six patients evaluated for the interim analysis had severe heart failure at baseline (mean left ventricle ejection fraction percentage in low 20’s and mean NT-proBNP of > 6,000 pg/ml), with persistent congestion despite being on high dose loop diuretics (mean furosemide equivalent dose of approx. 250 mg per day). Out of the six patients in the interim analysis, one patient had completed phase 2 of the study, three patients were in phase 2 and two patients were in phase 1.

After intensive alfapump DSR therapy in phase 1, patients had a mean weight loss of approx. 6kg or 7% of their body weight vs. baseline and all patients achieved euvolemia without the need of any loop diuretics. These interim data also showed a near normalisation of diuretic response with six-hour excretion of sodium more than doubling vs. baseline, as well as an improvement in NT-proBNP, a key cardiac function parameter, with a mean reduction of more than 30% vs. baseline. The mean eGFR (estimated Glomerular Filtration Rate) and creatinine after completion of phase 1 (active fluid removal) was similar to baseline, which is remarkable since worsening in kidney function during significant volume removal is the expectation in severely ill diuretic-resistant patients such as these. Patients who completed phase 1 are at less than 10% of their baseline loop diuretic dose (n=4, mean time post end of phase 1 is three months).

Serial alfapump DSR therapy was safe and well tolerated with few adverse events and there were no clinically significant changes in serum sodium levels or other electrolytes observed in these six patients after intensive DSR therapy.

To date, nine patients have been enrolled at two centers in SAHARA DESERT and implanted with the alfapump DSR system, of which six patients were evaluated for this interim analysis and two more patients just started study treatment. One additional patient was enrolled but died due to a cardiac arrest three days after study initiation. The death was deemed by the site unrelated to the study therapy, procedure or device; the Data Monitoring Committee assessed the event as possibly related to the study therapy but not related to the procedure or device. Patient enrollment continues as planned and reporting of top-line data is expected in H2 2022.

Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor of Sequana Medical, commented: “These interim results are highly encouraging and could potentially provide a course of therapy for severely ill diuretic-resistant heart failure patients with persistent congestion where alternative treatment options are currently exceedingly limited. We are looking forward to completing the study and presenting the top-line data of all patients by the end of next year.”

Dr. Oliver Gödje, Chief Medical Officer at Sequana Medical, added: “SAHARA DESERT represents the continuing development of our alfapump DSR therapy, and the interim results are a further indication of its unique capabilities. Our RED DESERT study showed that alfapump DSR could improve the diuretic response and cardio-renal status in patients with diuretic-resistant heart failure. SAHARA DESERT is building on these strong results as we focus on our anticipated patient population, those heart failure patients with persistent congestion, for whom oral diuretics is no longer effective at preventing fluid overload, a patient population particularly difficult to manage by healthcare professionals and where alfapump DSR could offer a real change in the treatment paradigm.”

Long-term follow-up of RED DESERT patients demonstrates sustained improvement of diuretic response

In May 2021, Sequana Medical reported strong top-line results of RED DESERT (NCT04116034) in seven euvolemic heart failure patients on high dose diuretics. Following the six-week study, patients continued to be followed for up to 19 months. One patient died nine months after the end of the study (unrelated to DSR therapy). All patients had a reduction in their oral loop diuretic dose ranging from 40% to 96% at their last visit within the follow-up period (9-19 months after last DSR treatment in the study), showing a significant durability to the improvement in diuretic responsiveness following alfapump DSR therapy.

Strong progress in development of proprietary DSR Infusate 2.0

A key element of Sequana Medical’s DSR programme is the development of the proprietary DSR Infusate 2.0, to deliver an infusate with a superior therapeutic profile as well as a high margin recurring revenue stream to accompany alfapump sales. Chemistry, Manufacturing and Controls (CMC) of DSR Infusate 2.0 is progressing well and pre-clinical development work is on track. The MOJAVE DESERT study, the first U.S. study of short-term DSR therapy in chronic heart failure patients with persistent congestion, is planned to start in H2 2022.

About SAHARA DESERT – alfapump DSR study in decompensated heart failure patients

SAHARA DESERT is a multi-centre, prospective, randomised, open-label study to evaluate the safety and feasibility of alfapump DSR® therapy in heart failure patients with persistent congestion and resistance to loop diuretic treatment. Twenty patients will be implanted with the alfapump DSR system. Following alfapump DSR implantation, patients undergo a diuretic challenge to quantify their response to diuretics, which is repeated at specific time points throughout the study. At the start of the study treatment period, loop diuretics are withheld, and patients are randomised 1:1 to DSR therapy with or without SGLT2-inhibitor to evaluate their impact on DSR therapy. Patients undergo intensive DSR therapy with DSR D10% infusate for two weeks (phase 1) which can be repeated up to two times depending on patients’ euvolemic state, diuretic response and stable DSR dosing at the end of phase 1. Patients who have achieved euvolemia and have adequate diuretic response enter the maintenance DSR treatment phase with monthly DSR dosing for 16 weeks (phase 2).

The primary safety and tolerability endpoints include the rate of treatment-, device- or procedure-related serious adverse events through the end of the maintenance phase. Secondary feasibility endpoints include the ability of DSR therapy to restore and maintain euvolemia without the need for additional loop diuretic treatment. Additional exploratory endpoints will evaluate the potential impact of SGLT-2 inhibitors on DSR therapy. The study is being conducted in up to three clinical centres in the Republic of Georgia. For more information about the study, please visit clinicaltrials.gov (NCT04882358).

About alfapump DSR in heart failure patients with diuretic-resistant congestion

alfapump DSR® is in clinical development as potential long-term treatment for heart failure patients with diuretic-resistant congestion. Congestion, also known as fluid overload, is the driver of more than 90% of the one million heart failure hospitalisations in the U.S. each year (which in total account for $13 billion in costs). The treatment options are severely limited in those patients for whom diuretics are no longer effective, which is evident from the 24% hospital re-admission rate at 30 days from discharge. Persistent congestion and worsening renal function is a key indicator of increased mortality in acute decompensated heart failure patients.

Sequana Medical’s proprietary DSR therapy is a unique approach that removes sodium from the body using diffusion in the peritoneal cavity with the use of a sodium-free solution (the “DSR infusate”). Once the sodium has been removed, the body eliminates excess fluid naturally through osmotic ultrafiltration and urination to restore the serum sodium concentration. alfapump DSR combines DSR therapy with the proven alfapump to deliver a fully implanted system for long-term DSR therapy. Strong top-line results from the RED DESERT study showed that repeated dose alfapump DSR therapy in diuretic-resistant heart failure patients is highly effective at managing the fluid and sodium balance and improves cardio-renal status. Following the six-week study, there was a dramatic improvement in patients’ diuretic response and a meaningful long-term reduction in their oral loop diuretic needs.

About Sequana Medical

Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases – including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure – with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.

The alfapump is Sequana Medical’s unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.

In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study and a rapid and persistent clinically important improvement in quality of life. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. Completion of enrolment was announced in December 2021 and the primary endpoint reporting is planned for Q4 2022. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 900 alfapump systems have been implanted to date.

Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT demonstrated that repeated DSR therapy in diuretic-resistant heart failure patients is able to not only manage the fluid and sodium balance of these patients but also restore their diuretic response and improve their cardio-renal status. The SAHARA DESERT study of alfapump DSR in decompensated heart failure patients is ongoing.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers

The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Note: alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux, China, the EU, United Kingdom, and Hong Kong.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

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Early Feasibility Study Demonstrates Successful Use of Abiomed’s preCARDIA Technology

The preCARDIA system is placed in the heart to intermittently occlude the superior vena cava. (Graphic: Business Wire)

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the successful results of the first-in-human early feasibility study of the preCARDIA system. The preCARDIA system is designed to improve decongestion in acutely decompensated heart failure (ADHF) patients by intermittently occluding the superior vena cava. The results of the study published this week in the journal Circulation: Heart Failure.

“The study met the safety and feasibility endpoints and suggests for the first time that with the preCARDIA system it is possible to rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava in patients with ADHF”

Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. Diuretics may help to improve heart failure symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with chronic heart failure. preCARDIA is designed to reduce filling pressure as blood enters the heart and lungs, which may enable the heart and kidneys to work more effectively, potentially providing therapy for patients non-responsive to diuretics, estimated to be approximately 300,000 of the one million U.S. ADHF admissions per year.

The multicenter, prospective, single-arm VENUS-HF Early Feasibility Study examined 30 patients with ADHF who were assigned preCARDIA therapy for 12 or 24 hours. The primary endpoint was a composite of major adverse events through 30 days. The study found:

  • Freedom from device- or procedure-related major adverse events in 100% of patients (n=30/30)
  • Successful placement, activation and removal of preCARDIA in 97% of patients (n=29/30)
  • Right atrial pressure decreased 34% from baseline (p<0.001)
  • Pulmonary capillary wedge pressure decreased 27% from baseline (p<0.001)
  • Urine output increased by 130% from pretreatment values (p<0.01)
  • Net fluid output increased by 156% from pretreatment values (p<0.01)

“The study met the safety and feasibility endpoints and suggests for the first time that with the preCARDIA system it is possible to rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava in patients with ADHF,” said Navin Kapur, MD, the study’s lead author and executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center.

The results support additional study of preCARDIA. In November, the United States Food and Drug Administration (FDA) authorized preCARDIA’s early feasibility study to be expanded by 30 additional patients to a total of 60 patients.

preCARDIA is an investigational device, limited by federal law to investigational use only.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com.

FORWARD-LOOKING STATEMENTS

Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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InterVene’s BlueLeaf Endovenous Valve Formation (EVF) System Granted Breakthrough Device Designation by the FDA

InterVene’s BlueLeaf Endovenous Valve Formation (EVF) System Granted Breakthrough Device Designation by the FDA

Below, we are re-publishing with permission the press-release issued by InterVene, Inc. on December 13, 2021

December 13, 2021 07:00 AM Eastern Standard Time

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–InterVene Inc. announced today that it has received Breakthrough Device Designation by the FDA for the company’s BlueLeaf® Endovenous Valve Formation System. BlueLeaf is the first catheter-based solution developed for deep vein reflux — the failure of venous valves in the legs — which does not require an implant. Clinical research is underway in three separate study programs worldwide, including an Early Feasibility Study (EFS) in the US.

The Breakthrough Device Designation is granted when a device meets several criteria, including providing more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

The BlueLeaf System is designed to correct one of the underlying causes of chronic venous insufficiency (CVI), Deep Vein Reflux (DVR), by forming new, autologous vein valves out of the patient’s vein wall tissue via an endovascular, ultrasound image-guided approach. To date, over 25 patients with varied anatomy, disease severity, and etiology have had new vein valves formed by US and international investigators using the BlueLeaf System. Both monocuspids and bicuspid valves have been formed.

“This is a meaningful milestone for the company which offers the potential for a more timely clinical research and regulatory process for BlueLeaf. Given the debilitating nature of DVR and the lack of an effective treatment option for these patients, we’re pleased with the FDA’s decision and look forward to productive collaboration with the agency. In addition, potential economic and reimbursement benefits remain an ongoing process which we’ll follow closely as we plan and develop the next phase of our clinical research,” noted InterVene CEO Jeff Elkins.

Approximately 6.5M Americans suffer from DVR and moderate to severe CVI, a disease characterized by elevated pressure in the leg veins. DVR involves the failure of venous valves in the legs, notably in those whose valves are damaged by post-thrombotic syndrome (PTS) after iliofemoral deep vein thrombosis (DVT), leading to poor blood flow back to the heart and pooling of blood in the legs. DVR patients tend to progress to the most severe symptoms, including skin breakdown and chronic ulcers, negatively impacting their quality of lifeThe current standard of palliative treatment involves compression therapy, leg elevation and local wound care yet does not address the underlying problem of deep vein valve failure.

“The FDA’s Designation of the BlueLeaf EVF System as Breakthrough is an important recognition of both the tremendous unmet need for Deep Vein Reflux patients and the potential of the novel non-implant valve technology as treatment for the severe symptoms they frequently experience. Solutions to DVR have been elusive despite decades of research, and InterVene’s autologous, endovenous approach is worthy of prioritization, so the designation is a fitting and positive development,” said William Marston, M.D., the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine.

About InterVene Inc.

Located in South San Francisco, InterVene is a product of the Stanford Biodesign Fellowship program and a former Company-In-Residence at the Fogarty Institute for Innovation. For more information and a video animation of the BlueLeaf procedure, visit www.intervene-med.com.

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AtriAN Medical’s Clinical Data Highlighted at the 2022 AF Symposium

Pioneering cardiac autonomic pulsed field ablation (PFA) technology provides a unique option for enhancing the durability of AF ablation.

GALWAY, Ireland, Jan. 17, 2022 /PRNewswire/ — Irish medical device company AtriAN Medical today announced that clinical data from it’s first-in-human study was presented at this years renowned Annual AF Symposium in New York City.

AtriAN has to-date enrolled nineteen patients in the company’s Neural AF multi-center study, using a unique cardiac autonomic ablation technology for the treatment of atrial fibrillation. The Neural AF study is assessing the safety and feasibility of AtriAN’s pulsed field ablation (PFA) technology for the selective ablation of cardiac autonomic neuronal tissue. An update on the clinical data was presented by Prof Vivek Reddy MD of Mount Sinai Hospital (NY), at the session on Late Breaking Clinical Trials and First Report Investigations, on January 14th, 2022.

The treatment methodology targets specific locations on the exterior surface of the heart where atrial fibrillation initiates. By delivering very short and precise electric fields, the device eliminates hyperactive neuronal cells at these locations. This leads to a reduction in the heart’s overall sensitivity to atrial fibrillation. 

The first procedures have been performed on patients undergoing concomitant coronary artery bypass grafting (CABG); at Tbilisi Heart & Vascular Clinic in Georgia and Na Homolce Hospital, in Prague, Czech Republic. “The AtriAN system is an exciting development, opening up the possibility of addressing the autonomic origin of atrial fibrillation, which has largely been ignored by existing ablation technologies,” said Prof Tamaz Shaburishvili of Tbilisi Heart & Vascular Clinic.

The AtriAN system includes catheters designed for use within the pericardial space and a generator for providing the low energy pulsed electric fields, that are delivered via the catheters, directly into the epicardial neuronal tissues. 

“The field of selective cardioneuroablation offers great promise among the treatment options for atrial fibrillation and it is exciting to see the AtriAN system now being assessed clinically,” said Prof Joris de Groot, at Amsterdam UMC. “Arrhythmia recurrence is a widespread problem with current ablation technologies – the AtriAN selective autonomic ablation has the potential to resolve this issue.”

“The positive outcomes from these initial patients is a key clinical milestone for us, following on from several years of scientific research and engineering development,” said AtriAN CEO Ken Coffey. “We look forward to continuing development of the technology in order to bring it to wider cohorts of patients.”

For more information about AtriAN Medical, please visit: www.atrianmedical.com

About AtriAN Medical: AtriAN Medical is an Irish medical device company based in Galway. They are currently engaged in efforts to pave the way for long term and non-thermal treatment of atrial fibrillation.

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Cardiovascular Systems, Inc. Announces First In-Human Experience With Coronary Everolimus Drug Coated Balloon

Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the start of enrollment in a first in-human trial of the coronary everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies, LLC (CVT).

The first patient was successfully treated by Dr. Irakli Gogorishvili, Head of the Interventional Cardiology Department, at the Israeli-Georgian Medical Research Clinic Helsicore in Tbilisi, Georgia. The coronary DCB was used to treat in-stent restenosis (ISR) located in the left anterior descending artery.

DCBs are a widely accepted percutaneous interventional treatment option for femoro-popliteal lesions in patients with peripheral artery disease, and are increasingly recognized for their potential in complex coronary artery disease, ISR, small vessels, and bifurcation lesions.

Everolimus, the active drug in CVT’s DCB formulation, acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis and has a long history of safety and efficacy in coronary drug-eluting stent applications.

Dr. Gogorishvili said, “The crossability and deliverability of the CVT DCB is excellent and I am very excited to participate in this research project evaluating this new class of DCBs.”

Ryan Egeland, MD, PhD, CSI’s Chief Medical Officer, said, “The CVT DCBs are designed to capitalize on the proven long-standing anti-restenotic benefits of everolimus for the treatment of patients with cardiovascular lesions. CVT intends to enroll 50 patients at up to 15 sites in France, Georgia, Lithuania and Spain to support an IDE submission to the FDA and a subsequent U.S. pivotal clinical study.”

Under the terms of the agreements signed with CVT, CSI is providing milestone-based financing to CVT for the development of coronary and peripheral DCBs. Under an acquisition option agreement, upon CVT’s completion of key technical and clinical milestones in the development program, CSI will have exclusive rights and obligations to acquire CVT, subject to the satisfaction of closing conditions set forth in the agreement.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit www.csi360.com and connect on Twitter @csi360.

About Chansu Vascular Technologies, LLC

Chansu Vascular Technologies (CVT) is a company with its principal office located in Sunnyvale, California. CVT was founded by Philippe Marco, MD, with the exclusive purpose to develop peripheral and coronary DCBs using everolimus. Dr. Marco is a 25-year medical technology veteran who has spent his entire career focused on cardiovascular device development. He was President and COO of Epix Therapeutics (acquired by Medtronic), and President and COO at CV Ingenuity (acquired by Covidien), where he was responsible for the development of the Stellarex™ DCB. Dr. Marco started working on drug delivery cardiovascular devices while in charge of Medical Affairs for Abbott Vascular where, following the Perclose Inc. acquisition, he led the franchise expansion into a diversified portfolio from closure devices to drug-coated coronary stents, embolic protection devices, and peripheral catheters and stents.

About Coronary Artery Disease (CAD)

CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the Centers for Disease Control and Prevention, 18.2 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, significant arterial calcium is present in about 30 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).

Safe Harbor

Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding (i) the development of new DCBs; (ii) the benefits of DCBs and everolimus; (iii) clinical studies relating to the DCBs; (iv) the ability of CVT, Dr. Marco and his team to successfully develop the DCBs; (v) future milestone-based financing in CVT; (vi) the future impact of adding DCBs to CSI’s portfolio; and (vii) the potential acquisition of CVT by CSI, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, the ability of CSI and CVT to collaborate on the development of new DCBs; the ability of CVT to meet development milestones; satisfaction of the conditions to CSI’s additional financing obligations; satisfaction of milestones and conditions to CSI’s rights and obligations to acquire CVT; technical challenges; regulatory developments; clinical trial requirements and results; FDA clearances and approvals; the experience of physicians regarding the effectiveness and reliability of products sold by CSI; the reluctance of physicians, hospitals and other organizations to accept new products; the impact of competitive products and pricing; general economic conditions; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

CSI is a registered trademark of Cardiovascular Systems, Inc. All other trademarks cited herein are owned by their respective owners.

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Restore Medical Announces First in Human Trial for Treatment of Heart Failure in Patients

Restore Medical Ltd.

ContraBand™ technology helps restore the heart’s functionality and may significantly improve patients’ quality of life

OR YEHUDA, Israel, Dec. 7, 2021 /PRNewswire/ — Restore Medical Ltd., a clinical-stage MedTech company developing cardiac implants for the treatment of congestive heart failure (CHF), today announced promising preliminary results of the First-in-Human clinical trial of ContraBand™, a breakthrough treatment for patients suffering from CHF. The minimally-invasive, catheter-delivered implants are used to treat patients with chronic left ventricular failure, where the heart is unable to pump sufficient oxygen-rich blood through the body.

Restore Medical has successfully implanted the ContraBand™ in its first patients at the ZNA medical center in Middelheim, Antwerp, Belgium, followed by Kaplan Medical Center in Israel.

“These first procedures are milestones in proving the ContraBand™ technology to be both safe and effective for heart failure patients,” said Gilad Marom, CEO of Restore Medical. “The positive impact this treatment can have on the millions of people suffering from CHF cannot be underestimated. Not only will it transform the quality of life of treated patients, but it will also reduce the enormous financial burden that comes as a result of patients being undertreated.”

The ContraBand™ is expected to relieve symptoms and improve patients’ quality of life by causing the healthy right ventricle to assist the failing left ventricle. The function of the implants is fully reversible even long after the procedure, which is unique in the field of cardiovascular implants.

CHF is a progressive, debilitating disease and is one of the leading causes of mortality, with less than half of patients surviving five years after diagnosis and only 30% surviving ten years. With 25% of patients returning to the hospital within a month of discharge, it is also the leading cause of repeat hospitalizations. CHF affects tens of millions of people worldwide, including 6.2 million in the United States alone, and is considered the largest unmet clinical and financial need facing global healthcare systems.

About Restore Medical Ltd.

Restore Medical has developed a novel technology that restores the geometry of failing hearts to improve patients’ quality of life. The company, which is led by the CEO Gilad Marom, was established in 2015 by Dr. Elchanan Bruckheimer (Medical Director), Aaron Feldman (board member) and Stephen Bellomo (VP, Clinical Affairs). The main investors include Incentive Incubator, Peregrine Ventures, Allegro and a strategic investor. Today, Restore Medical’s team includes top clinicians, engineers, and high-level specialists with extensive knowledge and experience in developing implantable cardiovascular devices and bringing these devices to market.

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