Tag: JenaValve

JenaValve Completes Enrollment in the ALIGN-AR IDE Clinical Trial

Landmark ALIGN-AR Pivotal IDE Study Intended to Evaluate Use of the Trilogy™ Heart Valve System in Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation IRVINE, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today […]

JenaValve Raises $100 Million to Advance Trilogy TAVR Solution

Financing Secures Funding to Complete ALIGN-AR Clinical Trial, Continue E.U. Real World Evidence Development, and Prepare for a U.S. Commercial Launch IRVINE, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) — JenaValve Technology, Inc. (“JenaValve or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced that […]

JenaValve Announces Results from First Commercial Trilogy Heart Valve System Implants in Europe

IRVINE, Calif., June 28, 2022 (GLOBE NEWSWIRE) — JenaValve Technology, Inc. (“JenaValve” or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, announced positive results from the first Trilogy Heart Valve System commercial implants for high-surgical risk patients with severe, symptomatic aortic stenosis (AS) or aortic […]

Peijia Medical Obtained Exclusive License for JenaValve’s Trilogy TAVR System for Treating AR in the Greater China Region

SUZHOU, China, Jan. 19, 2022 /PRNewswire/ — Peijia Medical Limited (HKEX: 9996) is pleased to announce its strategic investment and exclusive in-licensing agreement with JenaValve Technology, Inc. Under the terms of the agreement, Peijia has made a cash and equity investment in JenaValve and will commit additional capital based upon development milestones in […]

JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System

IRVINE, Calif., Oct. 18, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe. The procedures, which included treatment of both aortic regurgitation1 (AR) and aortic stenosis1 (AS), took place […]

JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial

IRVINE, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk […]

Establishing TAVR for the Treatment of Aortic Regurgitation(1)

JenaValve Marks the 100th Implant of the Trilogy™ Heart Valve System IRVINE, Calif., June 15, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of a novel transcatheter aortic valve replacement (TAVR) system, is pleased to announce today the 100th global implant of the Trilogy™ Heart Valve System. This milestone […]

JenaValve Technology Receives CE Mark for its Trilogy™ TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis

IRVINE, Calif., May 25, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement) for the treatment of aortic valve disease, today announced that it has received CE Mark for its TrilogyTM Heart […]

JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality

IRVINE, Calif., March 18, 2021 (GLOBE NEWSWIRE) — 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 Jane Metcalf to Vice President, Regulatory Affairs and Quality, effective immediately. Ms. Metcalf comes to JenaValve […]