JenaValve’s Trilogy TAVI System Receives CE Mark Approval

May 25, 2021—JenaValve Technology, Inc. announced that it has received CE Mark approval for its transfemoral Trilogy transcatheter aortic valve implantation (TAVI) system for the treatment of severe, symptomatic aortic regurgitation (AR) and aortic stenosis (AS) in patients at high surgical risk.

The Trilogy system, which features the company’s locator technology. Rather than relying on calcification to anchor the valve, the locators clip onto the patient’s native anatomy to provide valve security. The valve’s design also enables anatomical valve alignment, which facilitates future access to the coronary arteries and beneficial hemodynamics.

According to the company, the Trilogy system consists of a transcatheter heart valve and transfemoral delivery system. The bioprosthesis is composed of a self-expanding nitinol stent with a porcine pericardial tissue valve. The transfemoral delivery catheter is designed to deliver the bioprosthesis using a simple stepped approach to achieve anatomical positioning within the native valve. The system is available in three sizes to treat a range of annular diameters.

The Coprincipal Investigators of the study supporting CE Mark approval of the device are University Professor Stephan Baldus, MD, and University Professor Hendrik Treede, MD. Prof. Baldus is Director of the Heart Center Department of Cardiology at University Hospital Cologne in Cologne, Germany. Prof. Treede is Director of the Clinic and Polyclinic for Cardiovascular Surgery at the University Hospital Mainz in Mainz, Germany.

“We now have a minimally invasive therapy option available that is uniquely designed for the challenging anatomical characteristics of the AR patient,” commented Prof. Baldus in the company’s announcement. “The Trilogy valve system from JenaValve represents a significant improvement in our ability to confidently treat high surgical risk AR patients as this technology’s features address the shortcomings of the existing TAVI devices in terms of valve stability, hemodynamics, and coronary access.”

Prof. Treede, stated, “Alterations in the structure of valve complex in pure AR are distinct and present unique challenges due to absence of annular and leaflet calcification needed for device anchoring and stabilization during deployment. JenaValve’s locator technology provides a unique system of positioning and alignment with the native leaflets which I think provides my patients with several meaningful clinical advantages compared to current TAVI devices. With the Trilogy valve, we now have one aortic valve that meets the clinical demands of both AS as well as AR. I can see how this valve may play a significant role in the field of transcatheter aortic valve implantation in the near future.”