news
-
14 October 2021JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System
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 in multiple centers in Germany, marks the official start of the European commercial launch of Trilogy.
The Trilogy Heart Valve System is the first and only transfemoral TAVR system in the world indicated for the treatment of aortic regurgitation. In addition, The Trilogy system is also CE-Mark approved for aortic stenosis, providing European physicians, for the first time, a device with true dual-disease treatment capabilities.
“We are clearly thrilled about the first commercial implants of the Trilogy Heart Valve System in Europe. Our first commercial implants marked a major milestone accomplishment for JenaValve, but more importantly, there is now a minimally invasive option for patients with severe, symptomatic aortic regurgitation who are not candidates for open-heart surgery and medical management has become ineffective,” said John Kilcoyne JenaValve’s CEO.
“The Trilogy Heart Valve System is a highly innovative treatment option for AR patients, as legacy AS valves offered suboptimal treatment for AR symptoms,” said Prof. Dr. Stephan Baldus, principal investigator for AR in Europe. “JenaValve’s Trilogy System is an effective solution for AR patients that historically had very few options for treatment.”
Prof. Dr. Hendrik Treede, Principal Investigator for AS, also stated, “The Trilogy Heart Valve offers a new option for patients suffering from AR who previously did not have a sufficient treatment option. In addition to the significant advancement to treat patients with AR is, the Trilogy System offers benefits for patients with AS as well.”
The Trilogy Heart Valve System is a next-generation TAVR device indicated for the treatment of both AR and AS. Its unique design, highlighted by our proprietary locator technology, large open-cells for coronary accessibility, and advanced sealing ring, addresses a significant unmet need in the marketplace for patients suffering from AR. Trilogy is currently the only CE-Mark-approved TAVR system indicated for the treatment of both AR and AS. Beyond approval in the EU, JenaValve is actively enrolling in The ALIGN-AR Clinical Trial to demonstrate the safety and effectiveness of the Trilogy system in the United States. Based on clinical and commercial experience to date, we believe the Trilogy System has the potential to become the standard of care for patients with AR.
Related
JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial
JenaValve Technology Closes $50 Million Financing
JenaValve Technology Appoints John T. Kilcoyne as Chief Executive Officer
JenaValve Technology Appoints Keith D. Dawkins, M.D., as Board Member
JenaValve Technology Appoints Pieter Van den Steen As Chief Commercial Officer, General Manager
JenaValve Technology Appoints Janet M. Fauls As Vice President Of Regulatory Affairs
JenaValve Announces Certification of New Transcatheter Heart Valve Manufacturing Facility
Jenavalve bags $26.5M to support growth in competitive TAVR market
JenaValve appoints Peter C. Wulff as Chief Financial Officer
JenaValve appoints Victoria E. Carr-Brendel, Ph.D., as Chief Executive Officer
JenaValve appoints Jan Keltjens Interim Chief Executive Officer
JenaValve names Stefan Schreck, Ph.D., Chief Technology Officer
JenaValve names David J. Drachman Chief Executive Officer
JenaValve announces first implantation of Transapical TAVI System in Sweden
JenaValve expands Series C venture financing round
JenaValve Tavi System receives extended CE mark approval for treatment of aortic insufficiency
JenaValve announces first implantation of Transapical Tavi system in Canada