Microvention, a wholly owned subsidiary of Terumo Corporation, announced today that the Sofia EX 5Fr 115cm intracranial support catheter received US Food and Drug Administration (FDA) 510(k) clearance on 15 September 2023 for use in transradial access in addition to transfemoral access.
The unique design of the Sofia EX 5Fr catheter allows for great trackability, and its large inside lumen provides fast and effective tracking to intracranial locations in patients as well, according to a company press release. It also offers support and kink resistance due to being reinforced with a nitinol coil and stainless-steel braid, and the device has an inner polytetrafluoroethylene (PTFE) liner throughout its entire length with 12 transition zones optimised for pushability, Microvention further claims.
Sofia EX 5Fr radial access clearance marks Microvention’s first product intended for use in transradial access—whereby the neurovasculature is accessed via the radial artery in the wrist, as opposed to the femoral artery in the groin—and signifies the company’s “commitment to innovation”. In its recent release, Microvention says it “believes providers should have the ability to feel confident in our Sofia EX 5Fr in either the transradial or transfemoral access approach”.
“We are pleased to receive FDA clearance for Microvention’s Sofia EX 5Fr intracranial support catheter for transradial access,” said Carsten Schroeder, the company’s CEO. “This achievement signifies our commitment to radial neurointervention and represents our unwavering commitment to improving healthcare, and helping to save patient lives, while striving to be at the forefront of innovation.”