Boston Scientific's Safari² Guidewire Receives Approval in the United States and Europe

July 22, 2015—Boston Scientific Corporation announced US Food and Drug Administration clearance and European CE Mark approval for its Safari² preshaped guidewire, which is an enhanced version of the company’s Safari guidewire. Safari² is intended to facilitate the introduction and placement of interventional devices within the heart, including those used in transcatheter aortic valve replacement (TAVR) procedures. The Safari² guidewire is compatible for use with all TAVR devices, advised the company.

According to Boston Scientific, the Safari² guidewire provides streamlined device delivery with enhanced wire predictability and shape retention for interventional devices within the heart. Additionally, the Safari² product line offers three curve sizes, including a new extra-small curve designed for procedures involving patients with smaller ventricles.

The Safari² guidewire complements the company's Lotus valve system, a next-generation TAVR device that received European CE Mark approval in October 2013. In the United States, the Lotus device is an investigational device and is not currently available for sale. The Safari² guidewire and the Lotus valve system are distributed separately, advised Boston Scientific.

In the company’s press release, Wesley Pedersen, MD, commented, “Having a preshaped, universal TAVR 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.” Dr. Pedersen is Director of Valve and Structural Heart Disease at the Minneapolis Heart Institute in Minneapolis, Minnesota.