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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Congress CSI Focus D-HF, Frankfurt, Germany, December 10-11th 2021

Clinical Accelerator Ltd. booth at CSI Focus D-HF with – Managing Director Dr Nikolay Nikitin M.D Ph.D, Business Development Manager Anna Nikitina LL.B., and colleagues at VisCardia Inc. – CEO Dr Peter Bauer Ph.D, Dr Lee Goldberg, M.D., MPH, Professor of Medicine at the University of Pennsylvania.

Clinical Accelerator is proud to have sponsored the CSI Focus D-HF (Device therapies in heart failure) conference this year in Frankfurt, Germany.

Organized by Dr Horst Sievert, the two-day conference was one of the first to be in person in this Covid era. It saw the coming together of the community of leading medical device companies and academics within the heart failure field. Recent advancements in device-based therapy in this indication were presented, including new interatrial shunts, neuromodulation devices, transcatheter valve repair and replacement interventions, electric stimulation therapies, PVADs, monitoring systems and many other novel technologies. It was great to see many Clinical Accelerator-run studies presented over the course of the conference and to network and listen to interesting panel discussions on the place of emerging medical device therapies in the current management of patients with heart failure.

We greatly look forward to the next in person D-HF conference!

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Anteris Technologies CEO talks ‘outstanding results’ from first human DurAVR patients

Anteris Technologies CEO talks ‘outstanding results’ from first human DurAVR patients

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Abiomed Acquires preCARDIA, a Breakthrough Medical Device Company, to Improve Outcomes for Heart Failure Patients

June 1, 2021 8:03 AM

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) has acquired preCARDIA, developer of a proprietary catheter and controller that will complement Abiomed’s product portfolio to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA system is uniquely designed to rapidly treat ADHF-related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function.

“Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started”

Annually, more than one million patients are admitted to hospitals in the United States with ADHF. Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. preCARDIA provides heart failure specialists a minimally invasive solution with the potential to improve patient outcomes and lower the cost of care by providing early intervention with this new technology.

preCARDIA’s catheter-based system includes a proprietary superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC. Potential benefits for patients include improved response to medical management of ADHF, reduced duration of hospital stay, reduced re-hospitalizations and improved quality of life. The system is based on an invention by Navin Kapur, MD, and Richard Karas, MD, PhD, at the Molecular Cardiology Research Institute at Tufts Medical Center in Boston.

The design of the preCARDIA system allows for straightforward placement by physicians and hemodynamic monitoring by medical staff. The system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

“Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started,” said Lisa Wipperman Heine, president and chief executive officer at preCARDIA. “I am confident that the addition of our technology into Abiomed’s product portfolio will further improve outcomes for heart failure patients.”

preCARDIA completed enrollment of 30 patients in an FDA early feasibility study (EFS), which demonstrated acute technical success and significant reduction in cardiac filling pressures and rapid diuresis. Additionally, all patients were free of device- or procedure-related major adverse events through 30 days.

“Heart failure is a devastating condition associated with excess fluid overload known as congestion. preCARDIA is a breakthrough technology that regulates blood flowing into the heart known as preload, thereby reducing congestion and improving heart and kidney function,” said Navin Kapur, MD, physician-scientist and investigator in the Molecular Cardiology Research Institute at Tufts Medical Center, and the chief medical advisor and chair of preCARDIA’s Scientific Advisory Board. “This novel approach has the potential to be a revolutionary tool for the treatment of millions of patients suffering from acute heart failure worldwide.”

“We look forward to advancing preCARDIA’s technology through the regulatory process and expanding our relationship with heart failure specialists to help improve outcomes in early stage acute decompensated heart failure patients, a new patient population for Abiomed,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “This acquisition aligns with Abiomed’s principles of leading in technology and innovation and putting patients first.”

The preCARDIA system is available for investigational use only and is not approved for use outside of clinical studies. A projected timeline for commercialization will be announced later this fiscal year.

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.

ABOUT preCARDIA

preCARDIA is dedicated to improving patients’ quality of life through pioneering clinically advanced technology that offers an alternative solution for physicians and their patients suffering from ADHF. preCARDIA’s current technology, a proprietary balloon catheter and pump controller, is designed to address ADHF through cardio-renal volume unloading via intermittent superior vena cava (SVC) occlusion.

The company was founded & incubated by MD Start and is headquartered in St. Paul, Minnesota, USA.

CAUTION: The preCARDIA System is an investigational device and is limited by Federal (or United States) Law to investigational use. For more information, please visit: www.precardia.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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Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

Minimally-invasive, implant-free technology for heart failure patients studied at 1 and 3 months

Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

May 17, 2021 09:36 AM Eastern Daylight Time

AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical Inc., a privately-held medical device company, today announced one-month and three-month follow up data from the first in human clinical study (ALLEVIATE-HF-1) of its technology for the treatment of heart failure with preserved ejection fraction (HFpEF).

“Due to the limited medical or device options to treat heart failure with preserved ejection fraction, providers have few tools for helping patients manage the resulting shortness of breath and reduced quality of life”

The Alleviant System is a novel transcatheter device for the creation of a therapeutic interatrial shunt without a permanent cardiac implant. Results were presented at the American College of Cardiology Scientific Session (ACC.21) and at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) by Colin Barker, MD, Director of Interventional Cardiology at Vanderbilt University, Nashville, TN and Jacob Kriegel, MD, Chief Medical Officer of Alleviant Medical.

The reported results of this ongoing first in human study include safety and objective clinical and quality of life outcome measures at one and three-months post-procedure in ten subjects. Data highlights include:

  • Confirmed shunt patency in all subjects at 3 months;
  • Reduction in mean peak exercise pulmonary capillary wedge pressure (PCWP) by 20% (8 mmHg, p=.026) at 1 month;
  • Reduction in mean NT-proBNP by 48% (582 pg/ml, p<.001) at 3 months;
  • Increase in mean 6-minute walk distance by 50% (110 meters, p<.001) at 3 months;
  • Increase in mean Kansas City Cardiomyopathy Questionnaire overall summary score by 87% (23 points, p<.001, consistent with a large clinical improvement) at 3 months;
  • No device-related or procedure-related adverse events through 3 months

“Due to the limited medical or device options to treat heart failure with preserved ejection fraction, providers have few tools for helping patients manage the resulting shortness of breath and reduced quality of life,” commented James Udelson, MD, Chief, Division of Cardiology, Tufts Medical Center, an advisor to the company. “We are encouraged by these early data highlighting outcomes for a no-implant interatrial shunt procedure and look forward to collaborating on further clinical evidence development with the Alleviant technology.”

“Our focus and mission at Alleviant Medical is to deliver a simple, reproducible no-implant interatrial shunt technology to heart failure patients and healthcare providers,” said Adam Berman, CEO of Alleviant Medical. “We are very pleased with the investigator-presented data at these two prestigious cardiology conferences and look forward to subsequent data releases from the ongoing clinical studies with our technology over the upcoming months.”

About Alleviant Medical:

Alleviant Medical is a privately held medical device company that is dedicated to developing novel therapies for patients suffering from heart failure. The company has developed a transcatheter technology intended to decompress the left atrium without a permanent cardiac implant or open surgery. The procedure is designed to be performed under fluoroscopy (x-ray) and ultrasound guidance using a minimally-invasive approach and leverages standard interventional cardiology techniques. The company’s mission is to alleviate the significant clinical and economic burden of heart failure and to improve the lives of millions of patients suffering from this debilitating disease. Alleviant Medical’s investment partners include Vensana Capital, Broadview and Longview Ventures, TMC Venture Fund, S3 Ventures and an undisclosed strategic investor.

The Alleviant Medical technology is under investigational use only and not available for commercial distribution in the United States or any other market.

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Clinical Accelerator announces collaboration with InterVene for developing an endovascular device for deep vein valve failure

Clinical Accelerator announces collaboration with InterVene for developing an endovascular device for deep vein valve failure

Clinical Accelerator is pleased to announce that is has begun a collaboration with InterVene, to run an early human feasibility study (EHFS) on their novel endovascular device – BlueLeaf Endovenous Valve Formation System – for deep vein valve failure.

Currently, there is no minimally invasive therapy to treat deep vein valve failure and many patients require open surgery. InterVene’s system directly addresses this issue by being the first ever non-implantable, endovenous product which can be used to form new vein valves from layers of tissues that derive from the patient’s vein wall. The system allows for several valves to be formed after only one procedure, thus greatly reducing the burden and medical risk that patients otherwise face.  

The team at Clinical Accelerator are all delighted to have the opportunity to participate in this exciting project. We greatly look forward to advancing this device and attaining quality data.

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization has a strong emphasis on cardiovascular indications and performs clinical investigations of novel cardiac devices. 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 InterVene

InterVene is a medical device start-up company based in San Francisco, USA, focused on improving treatment for deep vein valve failure. InterVene is a product of the Stanford Biodesign Fellowship program and is a former Company-In-Residence at the Fogarty Institute for Innovation. For more information, please see their website: https://www.intervene-med.com/

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Positive Preliminary Clinical Trial Results Reported for Vascular Dynamics’ Novel Heart Failure Treatment Technology

Endovascular baroreflex modulation data presented


Feb 9, 2021

IRVINE, CALIF – (February 9, 2021) – Vascular Dynamics, Inc., a privately held medical device company focused on innovative, endovascular device-based solutions for cardiovascular conditions, has announced positive preliminary results from its clinical trial, “A Feasibility Study Exploring the Effect of the MobiusHD® Device in Patients with Heart Failure.”

Horst Sievert, MD, Director of the CardioVascular Center in Frankfurt, Germany and Tamaz Shaburishvili, MD, Head of the Cardiovascular Clinic at Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia shared preliminary results of the clinical trial as part of a CSI Focus D-HF webinar presented last week.

Baroreceptors are specialized nerve endings that respond to stretch and are located along the carotid arteries in the neck. These stretch receptors are essential to the body’s natural control of the cardiovascular system and its performance. The MobiusHD device is a carotid endovascular implant designed to amplify this natural baroreflex mechanism, signaling the brain to produce autonomic modulation for improved heart function.

EndoVascular Baroreflex Amplification (EVBA) is the procedure used to implant the MobiusHD device. EVBA has been previously evaluated successfully in the treatment of 89 hypertension patients. EVBA using the MobiusHD device is now being investigated as a treatment to help patients suffering with heart failure.

Prof. Sievert reported that 19 heart failure patients with reduced ejection fraction (HFrEF) were safely and successfully treated using the EVBA procedure with the MobiusHD device. Preliminary data from the three-month follow up were presented for the first 13 of these patients. Every patient demonstrated clinical improvement. Statistically significant changes in averages of Kansas City Cardiomyopathy Questionnaire scores, six-minute hallway walk distances, NT-proBNP levels, and left ventricular ejection fractions were reported.

“We are very excited about such positive initial results,” said Sievert. “The procedure is straightforward, using conventional carotid access techniques, and is very safe. The early results are impressive and point to a potential solution for appropriate heart failure patients. Further evaluation is recommended.”

“Preliminary results from this feasibility study in heart failure patients are very promising,” commented Ed Roschak, CEO of Vascular Dynamics. “We look forward to expanding these efforts to multiple clinical centers around the world. We will report additional results as they become available.”

About Vascular Dynamics, Inc.
Vascular Dynamics develops innovative, endovascular platform technologies to offer compelling treatment options for patients at risk of life-threatening conditions and underserved by conventional treatments. The company’s MobiusHD technology features the first endovascular device to use the body’s natural baroreflex mechanism to modulate the autonomic nervous system and help restore sympathetic balance. Clinical evaluations of this unique baroreflex modulation therapy for heart failure and high-risk hypertensive patients are in progress. More information is available at http://www.vasculardynamics.com.

CAUTION: In the United States, the MobiusHD® device is limited by law to investigational use only.

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Clinical Accelerator collaborates with Metavention on a study of a novel medical device for hypertension

Clinical Accelerator collaborates with Metavention on a study of a novel medical device for hypertension

Clinical Accelerator and Metavention have recently entered into a collaboration allowing Clinical Accelerator to join the program of feasibility studies already under way in the United States, New Zealand and Australia. Our organization will participate in the renal denervation trial of Metavention’s novel device to evaluate safety and effectiveness in patients with hypertension. With Clinical Accelerator’s strong focus on advancing cardiovascular medical devices, this is a very exciting project for our team to participate in and attain quality data for.

Metavention has developed a unique Integrated Radio Frequency (iRF) Denervation System, which is currently under investigation for renal, hepatic and multi-organ denervation – a novel intravascular procedure.  Designed to be a one time, minimally invasive procedure, the device uses radio frequency energy to disrupt over active sympathetic nerves. The use of this advanced technology in conditions like hypertension and type 2 diabetes is hypothesized to reduce blood pressure, improve blood sugar control and improve other metabolic disease such as non-alcoholic fatty liver disease (NAFLD).

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization has a strong emphasis on cardiovascular indications and performs clinical investigations of novel cardiac devices. 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 Metavention

Metavention, Inc. is a privately-held medical device company headquartered in Minneapolis, Minnesota and the developer of the iRF Denervation System, a novel technology designed to disrupt the sympathetic nerves that contribute to type 2 diabetes, high blood pressure, and other metabolic diseases.

CAUTION: The iRF Denervation System is not approved for sale in any region and is limited by Federal (US) Law to investigational use only.

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Clinical Accelerator receives ISO 9001:2015 quality certification

Clinical Accelerator has reached a new milestone by being awarded the ISO 9001:2015 certification.

The 2015 edition of ISO 9001, created by the International Organization Standardization (ISO), provides the latest standards that must be followed in order to demonstrate the quality of products and services that are offered. Being ISO certified, customers can have the utmost confidence and trust that the Clinical Accelerator team will take a pro-active, professional and structured approach to the organization and management of our clinical trials. 

Established in 2006, the company offers a large range of services to support all stages and phases of clinical trials with pharmaceutical products and medical devices. Such services include but are not limited to: clinical trial design and protocol development; study feasibility and site selection; clinical trial authorizations (IRB/EC and CA); project and site management, site monitoring; data management; biostatistics; safety monitoring; study logistics; medical writing; quality assurance and other regulatory affairs. This certification is just one demonstration of how Clinical Accelerator has developed into a respected and competitive member of the CRO industry. For more information on how we could help assist your clinical trial, please see our website: clinicalaccelerator.com, and get in touch!

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