BIOVALVE Trial Evaluates Biotronik's Resheathable TAVR System

May 12, 2015—Biotronik announced the completion of the BIOVALVE first-in-human trial for its new resheathable transcatheter aortic valve replacement (TAVR) device. Investigators implanted the Biotronik device in patients with severe symptomatic aortic stenosis. The study, which was conducted at the University Heart Center in Hamburg-Eppendorf, Germany, established the device’s safety at 30 days.

BIOVALVE investigator Henrik Treede, MD, will present clinical and performance data about the Biotronik TAVR device on May 20 during a Hot Line Session at EuroPCR 2015 in Paris, France.

Biotronik advised that with the BIOVALVE trial, the company confirms its aim to enter the structural heart market with a second-generation resheathable TAVR device for treating aortic stenosis. The resheathable Biotronik TAVR device features an 18-F delivery system that deploys a porcine pericardial valve mounted on a self-expanding nitinol stent.

The device’s resheathability—allowing the device to be retracted, repositioned, and redeployed in the correct position—aids the implantation procedure and improves patient safety, noted the company.

In Biotronik’s press release, BIOVALVE study investigator Ulrich Schäfer, MD, commented, “Resheathability is an essential safety feature for this type of TAVR device. The Biotronik device examined in the BIOVALVE trial features resheathability, which greatly improves the procedure's chance for an optimal outcome.”

Dr. Treede added, “As the average TAVR patient is typically older and often suffers from multiple comorbidities, these patients greatly benefit from the transfemoral approach used in the BIOVALVE trial. The Biotronik TAVR device’s ease of use means a simpler procedure and potentially fewer complications.”