TAMPA, Fla., July 2, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts. The SAB will provide expert insight and guidance while helping the Company further advance its research and development initiatives for the AMEND mitral valve repair device. The AMEND mitral annuloplasty ring has been designed to treat patients suffering from severe mitral regurgitation not deemed suitable for surgery.
“We are excited to be joined and supported by some of the world’s leading pioneers in mitral valve therapies,” said Dr. David Meerkin, Valcare Medical CMO. “Their combined experience and collective insights will greatly assist Valcare at this critical point as we significantly broaden and deepen our clinical experience.”
Members of the Valcare Medical Scientific Advisory Board include:
Dr. Isaac George, MD joined New York Presbyterian/Columbia University Medical Center in the Department of Surgery in July of 2001 as a resident in general surgery following his graduation from Duke University School of Medicine. Prior to receiving his MD, Dr. George completed a B.S. in Mechanical Engineering at Massachusetts Institute of Technology in 1997. Dr. George also completed a fellowship program in cardiothoracic surgery in 2011 as well as a fellowship program in interventional cardiology in 2012. Dr. George is an Associate Professor of Surgery and Medicine, and the Surgical Director of Structural Heart of the NYP health system. He is one of the few physicians in the world trained in both cardiac surgery and interventional cardiology. He is an expert in the most current and innovative procedures including Transcatheter Aortic Valve Replacement (TAVR), transcatheter valvular mitral valve repair (Mitraclip, Edge to Edge), transcatheter mitral and tricuspid valve replacement and surgical TAVR removal/explantation.
Dr. Scott Lim, MD, is a Professor of Medicine & Pediatrics at the University of Virginia and the University of British Columbia. He has developed a career focusing on novel therapies for heart valve, structural, congenital, and heart failure therapies. He has served as national primary investigator on transcatheter aortic, mitral, and pulmonary valve trials, as well as worked with multiple early-stage novel cardiac device therapies, particularly in mitral and tricuspid valve disease. In addition to authoring more than 250 scientific publications, 500 presentations, and 50 book chapters, Dr. Lim has been the founding editor through 5 editions of the most popular textbook on congenital heart disease, the Field Guide to Congenital Heart Disease & Repair. He has also spent more than two decades leading a charitable organization to teach cardiac disease care to physicians in developing countries.
Dr. Paul Sorajja, MD is the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center at the Minneapolis Heart Institute Foundation, and a cardiologist at Minneapolis Heart Institute® where he serves as the Director of the Center for Valve and Structural Heart Disease. Dr. Sorajja’s expertise is interventional cardiology, with a focus on bringing the latest innovative technologies to patients with valvular and structural heart disease. He was part of the team that performed the first transcatheter mitral valve replacement (TMVR) in the US and has the largest worldwide experience with the therapy. Dr. Sorajja currently serves as a national investigator for TMVR and for clinical trials in percutaneous treatment for tricuspid regurgitation. He has served on multiple national practice committees for valvular heart disease and hypertrophic cardiomyopathy. Dr. Sorajja has published more than 250 manuscripts as well as several books. He routinely lectures at national and international medical conferences and has received awards for his expertise in medical education. Dr. Sorajja is also highly active in developing intellectual property in these areas.
Dr. Azeem Latib, MD, Director of Structural Heart Interventions, Montefiore Health System, New York. Azeem is a world-leading expert in interventional cardiology, with a clinical focus on complex coronary interventions as well as transcatheter aortic, mitral, and tricuspid interventions. Following his clinical interests, Dr. Latib’s research centers on transcatheter aortic, mitral, and tricuspid interventions with a focus on device innovation. In addition, he performs research on drug-coated balloons, drug-eluting stents, and challenging lesion subsets.
Dr. Federico DeMarco, MD, PhD is the head of the Structural Heart Program and of the Interventional, Valvular and Structural Heart Interventions Unit in Centro Cardiologico Monzino in Milan. He trained in Interventional Cardiology at the Institut Cardiovasculaire Paris Sud in Massy, France, between 2005 and 2007, and until 2015 he worked as a senior staff interventional cardiologist at Niguarda Hospital in Milan. From 2015 to 2022 he helped build the largest Structural Heart Interventions program in Italy in Policlinico San Donato in Milan. His interventional experience is extensive, spacing from complex coronary interventions to TAVR, transcatheter mitral and tricuspid valve repair and replacement, PFO and LAA occlusion, peripheral interventions, and a wide variety of other endovascular interventions. He has been collaborating with multiple companies since 2012, both on product design and development with engineers and on early clinical experience with various device trials and first in man procedures. He authored and co-authored over 150 peer-reviewed publications and book chapters on coronary, aortic and mitral interventions and has a strong interest in new endovascular technology.
“We are honored to have these accomplished mitral valve experts join Valcare Medical’s Scientific Advisory Board,” said Steve Sandweg, Valcare Medical CEO. “Each of these individuals has made significant contributions and helped pioneer breakthroughs in the treatment of mitral valve disease. We look forward to leveraging the vast expertise of our SAB to help drive Valcare’s clinical and regulatory strategy.”
The innovative AMEND mitral valve repair device is a closed, D-shaped semi-rigid annuloplasty ring with proprietary anchoring capabilities. AMEND has been designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open-heart surgery, but is implanted via a less invasive, percutaneous approach.
The AMEND device is investigational and limited to investigational use only. The products are not available for sale or commercial distribution.