CE mark and FDA approval for new TAVI guidewire


Boston Scientific has received the CE mark and FDA clearance for its Safari2 pre-shaped guidewire—a new and enhanced version of the Safari Guidewire—for introducing and placing interventional devices within the heart (including those used in transcatheter aortic valve implantation; TAVI). The new guidewire is compatible for use with all TAVI devices.

According to a press release, the Safari2 Guidewire provides a streamlined device delivery with enhanced wire predictability and shape retention for interventional devices within the heart. Additionally, the press release reports, the Safari2 product line offers the widest guidewire choice with three curve sizes, including a new extra small curve designed for procedures involving patients with smaller ventricles, a current unmet need in this population.

Wesley Pederson, director of Valve and Structural Heart Disease at the Minneapolis Heart Institute (USA), says: “Having a pre-shaped, universal TAVI guidewire helps physicians deliver the replacement valve with reliability and consistency. This is a wonderful development to have a smaller curve size so that we can offer this less invasive treatment option to a broader range of patients because valvular disease can have a devastating impact on patient survival and quality of life.”

Prior to the introduction of the Safari guidewire, physicians could only use peripheral intervention guidewires manually shaped for TAVI procedures.  Safari was the first pre-shaped, TAVI guidewire on the market designed specifically to be used within the chambers of the heart.

The Safari2 Guidewire complements the Boston Scientific’s Lotus valve system (CE marked but not FDA approved),
which is a next-generation TAVI device that has beem designed to give physicians more control throughout the TAVI procedure.