JenaValve Technology Inc., a developer of a transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, has appointed two veteran medical device executives, Vinny Podichetty, M.D., MS as vice president, Clinical Affairs, and Jeff Thiel as vice president, Operations, effective immediately.
 
Dr. Podichetty is an accomplished medical device executive with approximately 20 years of clinical, medical and regulatory affairs experience. He has developed and managed successful multinational, high-profile clinical projects and regulatory plans in both startup and large company environments. He last served as vice president, Global Clinical & Regulatory Affairs at IRRAS, a global medical technology company based in San Diego, and previously held senior clinical affairs positions at Edwards Lifesciences, MicroVention, and Zimmer Biomet. His experience includes work in structural heart, interventional neuroradiology and orthopedics. Dr. Podichetty earned a doctor of medicine degree at MH Institute of Medical Sciences & Research and a master of science degree from Cleveland State University.
 
Thiel has more than 30 years of operations and executive leadership experience in medical devices, primarily with venture-backed emerging growth medical device companies. He last served as president and CEO of Devax Inc., a drug-eluting stent company which obtained CE Mark and U.S. investigational device exemption (IDE) approval for its Axxess bifurcation stent. He previously served as president and CEO of Radiance Medical Systems, where he initially served as vice president of Operations. He started his medical device career with St. Jude Medical, where he successfully transferred the company’s mechanical valve production from St. Paul, Minn., to Puerto Rico. He also served as a member of the Board of Directors of Micrus Endovascular, helping to drive it from a venture-backed startup to a public company and its subsequent sale to Johnson & Johnson. Thiel earned an MBA from the College of St. Thomas and a bachelor of science degree in economics from the University of Wisconsin-River Falls.
 
“As we look forward to accelerating our clinical and commercial development plans, I am pleased to have this caliber of management experience bolster our senior leadership team. Both Vinny and Jeff bring established track records in building and executing the growth strategies of emerging medical technologies,” said John Kilcoyne, CEO. “I look forward to their contributions to managing our collective efforts and driving our breakthrough TAVR technology to meet the significant unmet needs of patients who suffer from severe aortic regurgitation as well as aortic stenosis.”

JenaValve, with locations in Irvine, Calif., Leeds, U.K, and Munich, Germany, is focused on bringing to market the JenaValve Transfemoral TAVR System which consists of a transcatheter heart valve (THV) and a transfemoral delivery system. The bioprosthesis comprises a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue processing techniques. The transfemoral delivery catheter is designed to deliver the bioprosthesis using a simple stepped approach resulting in anatomical alignment with the native valves. The System is available in three sizes intended for aortic annulus diameters from 21mm to 27mm. JenaValve is backed by investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.

The JenaValve Transfemoral TAVR System is an investigational device in the United States and internationally.