FDA Clears Boston Scientific's Savion Guidewires for BTK Interventions

August 15, 2018—Boston Scientific Corporation announced FDA clearance of the Savion guidewires, which are designed for below-the-knee (BTK) interventions to help treat complex lesions and restore blood flow to the leg. Savion guidewires are now commercially available.

According to the company, the Savion FLX is a frontline 0.014-inch wire that features a resilient nitinol tip to allow physicians to navigate to the most distal and complex lesions in challenging BTK cases. The Savion DLVR is a maximum-support 0.014-inch delivery wire designed with the strength and structure for delivering targeted therapies distally with easier exchanges.

Both Savion guidewires are available in two lengths (FLX: 185 and 300 cm; DLVR: 182 and 300 cm) as well as two tip shapes (straight and angled).

In the company's announcement, Fadi Saab, MD, commented, “Complex BTK disease calls for tools well matched for the challenges we encounter. The Savion guidewires have been a nice addition in our first-line defense to both navigate tortuosity and deliver therapies more distally.”

Dr. Saab completed the first live case utilizing the Savion FLX guidewire at AMP, the 2018 Amputation Prevention Symposium, held August 8–11 in Chicago, Illinois. At AMP, the case was moderated by Jihad Mustapha, MD. Dr. Saab and Dr. Mustapha are from Advanced Cardiac & Vascular Centers of Grand Rapids, Michigan.