Biotronik, a leading manufacturer of cardio and endovascular medical devices, announced the completion of the BIOVALVE first-in-human trial for its new transcatheter aortic valve.
Study doctors successfully implanted the Biotronik device in patients suffering from severe symptomatic aortic stenosis. The study, which established the transcatheter aortic valve implantation (TAVI) device's early safety at 30 days, was conducted at the University Heart Center Hamburg-Eppendorf (UKE), Germany.
With the BIOVALVE trial, Biotronik confirms its aim 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; around 1.2 million patients are diagnosed with this condition in Europe alone.
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 aid 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.
"Resheathability is an essential safety feature for this type of TAVI device," said study investigator Dr. Ulrich Schäfer, UKE, 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," said BIOVALVE study investigator Dr. Henrik Treede, UKE, Hamburg. "The Biotronik TAVI device's ease of use means a simpler procedure and potentially fewer complications."
On May 20, Dr. Treede will present clinical and performance data about the Biotronik TAVI device during a hot line session at EuroPCR 2015 in Paris, France.
"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," stated Dr. Daniel Buehler, Biotronik president, Vascular Intervention.
"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."