Tag: JenaValve

JenaValve Technology Appoints Peter L. Spadaro Chief Commercial Officer

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Peter L. Spadaro, Jr. to the newly created position of Chief Commercial Officer. Mr. Spadaro is a highly accomplished cardiovascular sales and […]

JenaValve Technology Closes $50 Million Financing

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease, announces that it has raised $50 million in an equity financing led by Bain Capital Life Sciences. Additional participants in the financing included existing investors Andera […]

JenaValve Transcatheter Aortic Valve Replacement (TAVR) System Designated by FDA as Breakthrough Device

JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic Regurgitation Indication IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced […]

JenaValve Technology Strengthens Senior Leadership Team in Clinical Affairs and Operations

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer of a novel transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, today announced the appointment of two veteran medical device executives Vinny Podichetty, MD, MS as Vice President, Clinical Affairs, and Jeff Thiel as Vice President, Operations, effective […]

JenaValve Technology Appoints John T. Kilcoyne as Chief Executive Officer

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer, manufacturer and marketer of differentiated transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, today announced the appointment of veteran medical device executive John T. Kilcoyne as Chief Executive Officer, effective immediately. In addition, he will serve as a […]

JenaValve Technology Receives FDA Approval for Expanded IDE Enrollment in the Treatment of Patients with Severe Aortic Stenosis and Severe Aortic Regurgitation

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur™ transcatheter heart valve (THV) and […]

JenaValve Technology Initiates U.S. Patient Enrollment in Early Feasibility Study of Next-Generation TAVR System for the Treatment of Severe Aortic Stenosis and Severe Aortic Regurgitation

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment in the Early Feasibility Study (EFS) of its next generation JenaValve Pericardial TAVR System using the Everdur™ transcatheter heart valve (THV) and CoronatixTMTransfemoral Delivery Catheter at NewYork-Presbyterian/ […]

JenaValve Technology Implants Initial Patients in CE Mark Study for the Treatment of Severe Aortic Regurgitation with Next-Generation TAVR System

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment and implantations associated with the CE Mark study of its next generation JenaValve Pericardial TAVR System using the CoronatixTM Transfemoral Delivery Catheter for the percutaneous treatment of patients […]

JenaValve Technology Continues CE Mark Study Treating Severe Aortic Stenosis with Next-Generation System; Patient Enrollment and Successful Implantations with the Everdur™ Pericardial Aortic Valve and Coronatix™ Delivery Catheter

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer, manufacturer and marketer of differentiated transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, today announced successful patient enrollment in the CE Mark study of the next generation JenaValve Pericardial TAVR System utilizing the Coronatix™ Transfemoral Delivery Catheter for […]

JenaValve Technology Appoints Keith D. Dawkins, M.D., as Board Member

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer, manufacturer and marketer of differentiated transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, today announced the appointment of veteran medical device executive Keith D. Dawkins, M.D., as a new JenaValve board member. “As JenaValve advances its clinical development […]