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.