Biotronik has announced the completion of the BIOVALVE first-in-human trial for its new transcatheter aortic valve. Study doctors successfully implanted the 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.
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 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,” commented study investigator 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 device features an 18F 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, UKE, Hamburg. “The device’s ease of use means a simpler procedure and potentially fewer complications.”
On May 20, Treede will present clinical and performance data about the device during a Hot Line Session at EuroPCR 2015 (19–22 May, Paris, France).