July 28, 2015 — Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped Guidewire. Safari2 is an 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 device provides a streamlined 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.”
The Safari2 Guidewire complements the Boston Scientific Lotus Valve System, designed to give physicians more control throughout the TAVI/R procedure.
For more information: www.bostonscientific.com