Biotronik today said its entry into a hot replacement heart valve market passed the safety endpoint of a 1st-in-human trial.
The German medical device giant said the Biovalve trial of its transcatheter aortic valve implant established the device’s early safety at 30 days.
Biotronik said its 2nd-generation device is designed so that it can be retracted into a sheath and re-deployed. It consists of a porcine pericardial valve mounted on a self-expanding nitinol stent, the company said.
"Resheathability is an essential safety feature for this type of TAVI device. The Biotronik device examined in the Biovalve trial features resheathability, which greatly improves the procedure’s chance for an optimal outcome," investigator Dr. Ulrich Schäfer of the University Heart Center Hamburg-Eppendorf said in prepared remarks.
Dr. Henrik Treede, also an investigator at the Hamburg-Eppendorf center, is slated to present data about the Biotronik TAVI device at the EuroPCR conference in Paris May 20, the company said.
"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," Teede said in a press release. "The Biotronik TAVI device’s ease of use means a simpler procedure and potentially fewer complications."
"As an established and trusted provider of cardiac rhythm management and vascular intervention devices, Biotronik is now poised to bring the same unwavering commitment to quality and innovation to the structural heart market," added Biotronik vascular intervention president Dr. Daniel Buehler. "Our TAVI system’s ease of use and resheathing capabilities reflect our long-term 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."
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