Boston Scientific (NYSE:BSX) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its Safari2 pre-shaped guidewire designed for placing interventional devices in the heart.
The Safari2 is specifically intended for use with transcatheter aortic valve implantation or replacement procedures..
Boston Scientific’s new pre-shaped guidewire is compatible with all TAVI/R devices, the Marlborough, Mass.-based company said, and is the 1st pre-shaped TAVI/R guidewire designed specifically to be used in chambers of the heart.
“The Safari2 Guidewire reflects our dedication and our commitment to meaningful innovation in the treatment of structural heart disorders. We will continue to invest in technologies like Safari2 which facilitate successful TAVI/R outcomes and improve quality of life for patients with valvular disease worldwide,” Boston Scientific structural heart veep Tom Fleming said in a prepared statement.
The new-generation guidewire comes in 3 different curve sizes, including an extra small size designed for patients with smaller ventricals, which Boston Scientific said meets an unmet need in the population.
“Having a pre-shaped, 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,” Minneapolis Heart Institute director of valve and structural heart disease Dr. Wesley Pederson said in a press release.
Boston Scientific said the new guidewire complements its new Lotus valve system. The system currently has CE Mark approval in the European Union and is being tested in a pivotal trial under investigational device exemption in the U.S., but is not yet approved.