JenaValve Trilogy Heart Valve System Launched in Europe

October 18, 2021—JenaValve Technology, Inc., a developer and manufacturer of transcatheter aortic valve replacement (TAVR) systems, announced the launch of the Trilogy heart valve system in Europe.

According to the company, Trilogy is a transfemoral TAVR system approved for the treatment of aortic regurgitation (AR). In addition, the Trilogy system is CE Mark approved for aortic stenosis (AS), providing European physicians with dual-disease treatment capabilities. In Europe, the Trilogy device is indicated for severe, symptomatic AR and severe, symptomatic AS in high-surgical-risk patients.

The first commercial implantation procedures, which included treatment of both AR and AS, took place at multiple centers in Germany.

Professor Stephan Baldus, MD, Principal Investigator for AR in Europe, commented in the press release, “The Trilogy heart valve system is a highly innovative treatment option for AR patients, as legacy AS valves offered suboptimal treatment for AR symptoms. JenaValve’s Trilogy system is an effective solution for AR patients [who] historically had very few options for treatment.”

Professor Hendrik Treede, MD, Principal Investigator for AS, added, “The Trilogy heart valve offers a new option for patients [with] 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.”

In the United States, Trilogy is an investigational device limited by Federal law to investigational use. JenaValve is actively enrolling in the ALIGN-AR clinical trial to demonstrate the safety and effectiveness of the Trilogy system in the United States.