Below, we are re-publishing with permission the press-release issued by Axon Therapies on May 26, 2022

Late-breaking results presented at the European Society of Cardiology’s Heart Failure Association annual conference and simultaneously published online in the European Journal of Heart Failure

May 26, 2022 — Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced positive early results from a roll-in cohort for their feasibility IDE trial, REBALANCE-HF. The study is evaluating a novel frontline therapy called Splanchnic Ablation for Volume Management (SAVM) that aims to rebalance volume distribution in heart failure patients with preserved ejection fraction (HFpEF). The results support safety and efficacy of the SAVM procedure and signaled clinical improvements in key data including pulmonary capillary wedge pressure (PCWP) with exercise and patient quality of life metrics. Data was presented at the European Society of Cardiology‘s Heart Failure Association 2022 annual conference in Madrid, Spain and simultaneously published online in the European Journal of Heart Failure.

“It is very promising to see the positive early dataset and improvement in key clinical outcomes.  HFpEF patients have few treatment options today, and SAVM offers a minimally invasive, implant-free procedure designed to treat a root cause of their symptoms and hopefully slow down or stop disease progression – it has the potential to be a very exciting approach,” commented Marat Fudim, MD, Advanced Heart Failure Specialist at Duke University Medical Center. “I’m eager to see the longer-term results and patient outcomes from the study as they become available.”

The REBALANCE-HF study is a prospective, multi-center, randomized, sham controlled, double-blinded study enrolling 80 patients at up to 20 U.S. sites and is designed to assess the safety and efficacy of the SAVM procedure. The trial included a cohort of 18 single-arm, open-label roll-in patients for interim analysis that provided early data on the SAVM procedure using the Axon Ablation Catheter. While the findings require additional confirmation, early results are very promising. The therapy had a solid safety profile—all patients were successfully treated and three non-serious device-related adverse events were reported (heart failure decompensation requiring an ER visit, transient hypertension during the procedure, and back pain following the procedure). Patients showed improvement in PCWP with exercise as well as improvements in functional capacity, symptoms, and overall health status.

Key Results

• Significant reduction in PCWP at 20 watts and peak exercise at 1-month (p=0.007 and p=0.013, respectively)
• 33% of patients experienced improvement of at least one New York Heart Association (NYHA) class compared to baseline at 1-month (p<0.01)
• Significant improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) (22.1 pts at 1-month, p <0.01; 18.3 pts at 3-months, p<0.01)

Sanjiv Shah, MD, who is the National Principal Investigator of the REBALANCE-HF trial, stated, “The SAVM procedure offers a novel approach to potentially improving outcomes in patients suffering from heart failure by reducing sympathetic nerve activity to restore volume balance within the circulation. The early data from the REBALANCE-HF trial, demonstrates the potential promise and importance of managing volume shifts in this underserved patient population.” Dr. Shah is Director of Research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

“The data for this first cohort of patients is very encouraging. We anticipate completing enrollment in REBALANCE-HF later this year and sharing the full results next year,” stated Chad Hoskins, CEO of Axon Therapies. “The data builds on the results of our pilot studies, which demonstrated a durable effect of SAVM at 1 year. We’re grateful for the work of our investigators, and we look forward to the culmination of these efforts in a pivotal trial beginning in 2023.”

For more information: axontherapies.com

Below, we are re-publishing with permission the press-release issued by AtriAN Medical on September 06, 2022

This follow-up trial builds on AtriAN’s initial safety and feasibility study and aims to assess the efficacy of its cardioneuroablation treatment in patients with atrial fibrillation. 

GALWAY, Ireland, Sept. 6, 2022 /PRNewswire/ — AtriAN Medical today announced that it has completed enrollment of a second study using its selective pulsed field ablation (PFA) technology for the treatment of atrial fibrillation.

The Neural AF-2 study has enrolled cardiothoracic surgery patients with paroxysmal AF, utilizing AtriAN’s unique cardiac autonomic ablation technology to provide selective ablation of neuronal structures on the outside of the heart. A total of 12 patients were treated at Tbilisi Heart and Vascular Clinic (Georgia), with Prof Tamaz Shaburishvili as the Principal Investigator. Patients will be followed out to 1 year for AF recurrence.

The new study builds on AtriAN’s initial Neural-AF study that focused on safety, feasibility and acute outcomes, in twenty four patients undergoing concomitant coronary artery bypass grafting. The initial study was performed at Na Homolce Hospital in Prague (Czech Republic) and Tbilisi Heart and Vascular Clinic (Georgia). Data from that study was presented by Prof Vivek Reddy MD (Mount Sinai Hospital, NY) at the 2022 AF Symposium and by Prof Joris de Groot (Amsterdam UMC) at the European Heart Rhythm Association (EHRA) 2022 conference. 

The original Neural-AF study was an all-comers design for CABG patients that did not focus specifically on patients with atrial fibrillation. The findings indicate that selective epicardial PFA of ganglionated plexi is feasible and safe.  An acute extension in atrial tissue refractoriness was also recorded; this is a well recognized indicator of resistance to atrial fibrillation.

 “The promising results from our first study have given us the confidence and momentum to expand into this second trial looking specifically at clinical outcomes in patients with AF” said AtriAN CEO Ken Coffey. “This will be a challenging cohort of patients but we look forward to providing them with improved outcomes and demonstrating the potential of our novel approach.”

The AtriAN system includes catheters designed for use within the pericardial space and a generator for providing low energy pulsed electric fields. In the near future, the company plans to conduct clinical studies to assess delivery of the treatment using sub-xiphoid minimally invasive access.

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

Below, we are re-publishing with permission the press-release issued by Cardiovascular Systems, Inc. on March 16, 2022

ST. PAUL, Minn.–(BUSINESS WIRE)– 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 first in-human experience with Propel™, its first-generation percutaneous ventricular assist device (pVAD), offering hemodynamic support for patients undergoing high-risk percutaneous coronary interventions (HR-PCI).

The first series of patients was treated by Dr. David E. Kandzari, MD, FACC, FSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Atlanta, Ga., performed in Tbilisi, Georgia. Propel performed as intended, providing uninterrupted hemodynamic support leading to successful revascularization.

Propel is designed to meet the needs of the HR-PCI patient by providing clinically meaningful hemodynamic support while minimizing access site and procedural complications due to a small profile pump and smaller catheter body versus the current pVAD systems that are commercially available. Propel is percutaneously inserted, and the blood inlet portion of the device is positioned within the left ventricle below the aortic valve, and the outlet positioned above the aortic valve.

Propel was used at multiple support levels, with a hemodynamic power output and duration sufficient to maintain the stability of patients during their HR-PCI.

As one of the study investigators, Dr. Kandzari said, “This is a novel pVAD system that enables a 12 French in-body pump with a 7 French in-body catheter. This reduction in size may reduce the clinical complications associated with high-risk procedures while providing the clinically necessary cardiac support for the patient. The lower catheter profile may also increase the potential for use in patients with challenging anatomy that exclude treatment with current therapies.”

“Today’s announcement is another important milestone for CSI as we seek to develop an exciting pipeline of new products designed to improve the outcomes for patients with coronary artery disease,” said Scott R. Ward, Chairman, President and Chief Executive Officer of CSI. “We appreciate Dr. Kandzari’s commitment and willingness to participate in these first cases. Conducting the first in-human cases outside the U.S. increases the confidence we have in Propel and furthers the development of this program. We continue to work closely with FDA, and the data from these cases will inform the design and conduct of an early feasibility study in the U.S.”

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 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, arterial calcium is present in 38 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).

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 http://www.csi360.com and connect on Twitter @csi360.

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 Propel; (ii) future clinical studies and regulatory submissions relating to Propel; and (iii) CSI’s product pipeline, 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 to develop Propel; 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.

Spatial Resynchronization Therapy™ (SR ™Т) Successfully Terminated Atrial Fibrillation

Below, we are re-publishing with permission the press-release issued by Maxwell Biomedical on July 14, 2022

SAN DIEGO, Calif., July 14, 2022. Maxwell Biomedical announced today that it has initiated its First-ln­ Human Clinical Trial “Initial Experience with Spatial Resynchronization Therapy in Patients with Atrial Fibrillation (SR-TheAF)” at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. The study is designed to test the acute safety and efficacy of Spatial Resynchronization™ Therapy (SR™T) in patients with а history of atrial fibrillation (AF). The study will enroll up to 30 patients. During the initial studies, AF was successfully detected and termination with SRT pacing was demonstrated.

Spatial Resynchronization Therapy (SRT) is а Maxwell’s proprietary algorithm designed specifically to treat AF. Once AF is detected, SRT delivers pacing stimuli across а spatially distributed array of electrodes placed on the pericardial wall of the left atrium. Pacing stimuli, which are imperceptible to the patient, are precisely delivered to restore normal rhythm.

“We are very excited about the acute performance of SRT in this first series of patients,” stated Randy Werneth, СЕО of Maxwell Biomedical, “This represents а major milestone in our development pathway to bring а device-based treatment option to patients with AF.” Working alongside the surgical team in Tbilisi was Mehdi Razavi, MD, an entrepreneurial electrophysiologist from the Texas Heart Institute in Houston Texas, who has been working closely with the Maxwell Biomedical team to develop and pre­ clinically test the SRT concept. “In the past, pacing was tried with limited success to convert AF to а normal rhythm,” said Dr. Razavi, “SRT is а new methodology, based on insights gained from past experiences and rooted in the underlying biophysics of human fibrillatory conduction.”

AF is the most common heart arrhythmia affecting over ЗЗ million patients worldwide.¹ It occurs when the upper chambers beat uncontrollably and are out of synchronization with the lower chambers of the heart. The lack of coordinated contractions during prolonged episodes of AF increases the likelihood of blood clot formation and reduces the amount of blood available to pump to the body. AF increases stroke risk five times², increases mortality rates two-fold in heart failure patients³ and costs the United States healthcare system $26В annually¹. Current AF treatment options include outpatient cardioversion, rate or rhythm control medications and catheter ablation. SRT would offer patients а non-destructive, minimally invasive option to treat  their AF.

About Maxwell Biomedical

We are а development stage, science driven, innovative medical technology company with outstanding people dedicated to advancing long-term solutions for patients with Atrial Fibrillation.

Maxwell is developing а first of its kind, non-ablative, atrial pacing device that automatically detects AF and imperceptibly delivers Spatial Resynchronization Therapy (SRT) to restore and maintain а normal heart rhythm. Device monitoring and cloud connectivity ensures active and continuous patient care and management. Founded in 2019, Maxwell Biomedical is based in San Diego, СА.

1. Chugh SS et al. Worldwide epidemiology of atrial fibrillation. А global burden of disease study 2010.Circulation; 129:2014.
2. Virani SS et al. Heart disease and stroke statistics – 2021 update: а report from the American Heart Association. Circulation;143:2021.
3. Chamberlain АМ et al. Atria/ Fibrillation and Mortality in Heart Failure. Circ: Heart Failure;4(6):2011.

Clinical Accelerator, a full-service, medical device focused contract research organization, is excited to announce a new collaboration with Argá Medtech, on their feasibility study exploring the safety and efficacy of Argá’s non-thermal cardiac ablation system targeting Atrial Fibrillation (AF)

The system is a next generation of Pulsed Field Ablation and Irreversible Electroporation, offering an alternative to RF and Cryo – the most commonly used sources of energy for cardiac ablation. The system is hoped to result in a safer and faster procedure with improved clinical outcomes for AF patients.

The study is planned to enrol 10 patients and will be managed by Clinical Accelerator at our partner sites. It is currently in the set-up phase, and we are very excited to see its progression!

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.

Below, we are re-publishing with permission the press-release issued by Miracor Medical on March 29, 2022

AWANS, Belgium, March 29, 2022 /PRNewswire/ — Miracor Medical SA (Miracor Medical) today announced the first patient enrolled in the PICSO-AMI-V study to evaluate the benefits of PiCSO^® (Pressure Controlled Intermittent Coronary Sinus Occlusion) therapy as an adjunct to conventional primary percutaneous coronary intervention (PCI) for patients presenting with inferior ST-Elevation Myocardial Infarction (STEMI).

The first patient enrolled was treated at the University Hospital of Toulouse, France by the team of Professor Didier Carrié (Drs T. Lhermusier and F. Campelo). “Our team started using the PiCSO therapy for anterior STEMI patients in 2021. We are delighted to explore new indications and now start using PiCSO for inferior STEMI patients in the context of the PiCSO-AMI-V study,” says Prof. Carrié.

Improving outcomes for patients with large heart attacks remains an important unmet need

The principal investigator of the study is Professor Adrian Banning, Oxford Heart Center, Oxford, UK. “We are pleased to be initiating the PiCSO-AMI-V study. It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart. The study builds upon the data from the First-In-Man study that we published in 2021³. We know that improving outcomes for patients with large heart attacks remains an important unmet need, especially because these patients often progress to develop heart failure.” says Prof. Banning.

PICSO-AMI-V is a prospective, randomized, multicenter feasibility study and will enroll 75 inferior STEMI patients presenting with TIMI 0 & 1 flow, at up to 10 clinical sites in Europe. In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a conventional strategy of primary PCI alone. Adverse Device Effect (ADE) rate at 30 days post index procedure will be assessed as the primary endpoint. In addition, cardiac function and clinical safety endpoints – including death, heart failure-related hospitalization, new onset or worsening of heart failure – will be assessed. The patients will be followed for 1 year.

PiCSO therapy has demonstrated positive results in several clinical studies. Data from two recent studies (“PiCSO in ACS” and “OxAMI-PICSO”) showed that the use of the PiCSO Impulse System is associated with a significant infarct size reduction in anterior STEMI patients ^1,2. Furthermore, OxAMI-PICSO³ showed an early improvement in coronary microvascular function post PiCSO treatment in both anterior and inferior STEMI patients. PiCSO therapy accelerates the microcirculatory recovery resulting in significantly lower IMR (Index of Microcirculatory Resistance) and RRR (Resistive Reserve Ratio) post procedure when compared with controls.

“We are thrilled to start this second randomized clinical trial in Europe, and to progress our strategy to expand indications beyond our initial indication of anterior STEMI. The PiCSO-AMI-V Inferior STEMI study will complement the ongoing PiCSO-AMI-I (Anterior STEMI) study, which has enrolled more than 100 anterior STEMI patients and is anticipated to complete enrollment during the second semester of this year. We also recently treated the 300^th patient with the PiCSO therapy, illustrating the acceleration of usage and experience with the therapy,” says Olivier Delporte, CEO of Miracor Medical.

PiCSO therapy is used during the primary PCI procedure in acute myocardial infarct (AMI). Via its unique differentiated mechanism of action the PiCSO Impulse System clears the coronary microcirculation by intermittently occluding the coronary sinus outflow. The use of the PiCSO Impulse System has been associated with a reduction in infarct size after STEMI, which has been shown to lead to reductions in heart failure hospitalizations and reduced mortality⁴. Heart Failure develops in 18-28% of patients 90 days after their STEMI ⁵.

The PiCSO-AMI-V Inferior STEMI study is partially funded by a recoverable cash advance granted by the Walloon Region to Miracor Medical.

About Miracor Medical
Miracor Medical (www.miracormedical.com), located in Awans, Belgium, provides innovative solutions for the treatment of severe cardiac diseases, aiming to improve short and long-term clinical outcomes and reduce associated cost.

Miracor Medical develops the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function and potentially reduce the onset of heart failure following acute myocardial infarction.

NOTE: The PiCSO^® Impulse System is commercially available for anterior STEMI patients in EU, UK and EFTA. It is not commercially available for inferior STEMI patients.

¹ De Maria, et al. (2018). Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction – Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention 2018;14(3):e352-e359

² Egred, et al. (2020). Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. Int J Cardiol Heart Vasc, 28, 100526. https://doi.org/10.1016/j.ijcha.2020.100526

³Scarsini, et.all. (2021), Oxford Acute Myocardial Infarction, S., Kharbanda, R., Ferreira, V. M., Channon, K. M., De Maria, G. L., & Banning, A. P. (2021). Pressure-controlled intermittent coronary sinus occlusion improves the vasodilatory microvascular capacity and reduces myocardial injury in patients with STEMI. Catheter Cardiovasc Interv, Epub ahead of print(doi: 10.1002/ccd.29793). https://doi.org/10.1002/ccd.29793

⁴ Stone, et al. (2016). Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12, 67(14), 1674-1683.

⁵ Cahill, et al. (2017). Heart failure after myocardial infarction in the era of primary percutaneous coronary intervention: Mechanisms, incidence and identification of patients at risk. World J Cardiol. 2017 May 26;9(5), 407-415.