Biotronik, a leading manufacturer of cardio and endovascular medical devices has completed BIOVALVE first-in-human trial for its new transcatheter aortic valve. Biotronik 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. Biotronik aim is 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.
The resheathable Biotronik TAVI device features an 18 F delivery system which deploys a porcine pericardial valve mounted on a self-expanding nitinol stent.
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