JenaValve Technology

JenaValve Technology develops and commercializes transcatheter aortic valve replacement (TAVR) systems for treating patients with aortic valve disease. Its flagship product, the Trilogy Heart Valve System, is designed to treat patients with symptomatic, severe aortic regurgitation (AR) and symptomatic, severe aortic stenosis (AS) who are at high surgical risk.

The Trilogy System employs proprietary locator technology that securely anchors the valve to the native anatomy without relying on calcification, enabling precise anatomical alignment and facilitating future coronary access. This design addresses the challenges associated with AR, where the absence of calcification poses issues for traditional TAVR devices. The Trilogy System's advanced sealing ring also contributes to its better hemodynamic performance.

In May 2021, the Trilogy System received CE Mark approval, making it the first TAVR device in Europe indicated for the treatment of AR and AS. As of July 2024, JenaValve was conducting the ALIGN-AR Pivotal Trial in the US to support FDA approval for the Trilogy System's use in treating symptomatic, severe AR patients.

Key customers and partnerships

JenaValve serves healthcare providers and institutions specializing in cardiovascular treatments. JenaValve initiated its European commercial launch in October 2021, with the first implants demonstrating promising outcomes for AR and AS patients. As of June 2022, early commercial results reported a 100% technical success rate.

In January 2022, JenaValve formed a strategic partnership with Peijia Medical Limited, granting the latter exclusive rights to develop and commercialize the Trilogy System in Greater China. This collaboration led to the first two implantations in Asia, performed at Queen Elizabeth Hospital in Hong Kong. 

In November 2023, JenaValve joined the American Society of Echocardiography Industry Roundtable to drive awareness and education of cardiac imaging for AR detection and diagnosis. In June 2023, partnered with egnite to use egnite’s database to quantify the prevalence and treatment patterns of AR.