Boston Scientific announces CE mark and FDA clearance for the Safari2™ Pre-Shaped Guidewire

First Guidewire Designed Specifically for TAVI/R Now Sized for Smaller Ventricles 

Boston Scientific (NYSE: BSX) announces CE Mark and FDA clearance for the Safari2™ Pre-Shaped Guidewire, a new and enhanced version of the  Safari Guidewire, intended to facilitate the introduction and placement of interventional devices within the heart, including those used with transcatheter aortic valve implantation or replacement procedures (TAVI/R). The Safari2 Guidewire is compatible for use with all TAVI/R devices.

The Safari2 Guidewire provides a streamlined device delivery with enhanced wire predictability and shape retention for interventional devices within the heart. Additionally, 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.

“Having a pre-shaped, universal TAVR guidewire helps physicians deliver the replacement valve with reliability and consistency,” said Wesley Pederson, M.D., director of Valve and Structural Heart Disease at the Minneapolis Heart Institute. “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/R procedures.  Safari was the first pre-shaped, TAVI/R guidewire on the market designed specifically to be used within the chambers of the heart. View or download an image of the Safari² Guidewire.

“The Safari2 Guidewire reflects our dedication and our commitment to meaningful innovation in the treatment of structural heart disorders,” said Tom Fleming, vice president and general manager, Structural Heart, Boston Scientific. “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.”

The Safari2 Guidewire complements the Boston Scientific Lotus™ Valve System, a next-generation TAVI/R device designed to give physicians more control throughout the TAVI/R procedure. The Lotus Valve System received CE Mark approval in October of 2013 and offers a unique alternative treatment for patients with severe aortic stenosis and who are at high risk for surgical valve replacement.  In the U.S., the REPRISE III pivotal clinical trial began enrolling patients last year and is designed to evaluate the safety and effectiveness of the Lotus Valve System.  As such, the Lotus Valve System is an investigational device in the U.S. and not available for sale. The Safari2 Guidewire and the Lotus Valve System are distributed separately.

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