Boston Scientific Wins CE Mark, FDA Approval for Guidewire

Boston Scientific’s next-generation Safari2 pre-shaped guidewire has secured both CE mark and FDA approval, the Marlborough, Mass., devicemaker said Wednesday.

The product, meant to facilitate the implantation of cardiac interventional devices, is compatible with all transcatheter aortic valve or replacement systems, the company says.

Previously, physicians could use only peripheral intervention guidewires manually shaped for TAVI/R surgeries, the devicemaker claims. With this new guidewire, doctors should be able to administer new valves more reliably and consistently.

The Safari2 comes in three curve sizes, including an extra small curve for patients with smaller ventricles. — Jason Scott