Biotronik Completes Biovalve In-Human Trial

Biotronik SE & Co. KG has completed the first-in-human trial for its new transcatheter aortic valve, appropriately dubbed Biovalve.

Study doctors successfully implanted the Biotronik device in patients suffering from severe symptomatic aortic stenosis. The trial, which established the transcatheter aortic valve implantation (TAVI) device’s early safety at 30 days¹, was conducted at the University Heart Center Hamburg-Eppendorf (UKE) in Germany.

Biovalve marks Biotronik’s attempt to enter the structural heart market with a second-generation resheathable TAVI device for treating aortic stenosis. The most prevalent valvular heart disease, aortic stenosis is particularly common in those over the age of 75; approximately 1.2 million patients are diagnosed with this condition in Europe alone.² Many of these patients are eligible for TAVI, a catheter-based procedure that replaces a patient’s diseased native aortic valve with a bioprosthesis. To help with the implantation and improve patient safety, the Biotronik TAVI device allows for resheathability — meaning that, if necessary, the valve can be retracted into the delivery sheath, repositioned and redeployed in the correct position, company executives said in a news release.

“Resheathability is an essential safety feature for this type of TAVI device,” noted study investigator Ulrich Schäfer, M.D., medical director of the Department of General and Interventional Cardiology in the Heart Center at the University Medical Center Hamburg-Eppendorf (UKE) in Hamburg, Germany. “The Biotronik device examined in the Biovalve trial features resheathability, which greatly improves the procedure’s chance for an optimal outcome.”

The resheathable Biotronik TAVI device features an 18 F delivery system which deploys a porcine pericardial valve mounted on a self-expanding nitinol stent. “As the average TAVI patient is typically older and often suffers from multiple comorbidities, these patients greatly benefit from the transfemoral approach used in the Biovalve trial,” explained Biovalve study investigator Henrik Treede, M.D., a cardiac surgeon at UKE. “The Biotronik TAVI device’s ease of use means a simpler procedure and potentially fewer complications.”

Treede presented clinical and performance data about the Biotronik TAVI device during a conference earlier this year in Paris, France.

“As a provider of cardiac rhythm management and vascular intervention devices, Biotronik is now poised to bring commitment to quality and innovation to the structural heart market,” said Daniel Buehler, Ph.D., Biotronik’s president of Vascular Intervention. “Our TAVI system’s ease of use and resheathing capabilities reflect our expertise in developing catheter-based interventional devices, which has allowed us to streamline performance and grant patients enhanced treatment options. We eagerly look forward to further study results confirming the system’s safety and efficacy.”

Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is based in Lake Oswego, Ore.

References:

1. According to VARC-2 definition: Kappetein et al. EuroIntervention. 2012, 8.
2. Mylotte et al. Journal of the American College of Cardiology. 2013, 62.