JenaValve Technology has announced the first commercial implants with the Trilogy heart valve System in Europe. The procedures, which included treatment of both aortic regurgitation (AR) and aortic stenosis (AS), took place in multiple centres in Germany, and marks the official start of the European commercial launch of Trilogy.
The Trilogy heart valve system is a transfemoral transcatheter aortic valve implantation (TAVI) system approved for the treatment of AR and CE-Mark approved for AS.
“We are clearly thrilled about the first commercial implants of the Trilogy heart valve system in Europe. This is 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 Stephan Baldus (Kardiologie Uniklinik Köln, Cologne, Germany) 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.”
Hendrik Treede (University Heart Center Hamburg, Hamburg, Germany), 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 novel TAVR device indicated for the treatment of both AR and AS. It features open-cells for coronary accessibility, and advanced sealing ring, addresses a significant unmet need for patients suffering from AR.
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 USA.