FDA Clears Intracranial Support Catheter from MicroVention

MicroVention, Inc. announced that the SOFIA EX 5F 115 cm Intracranial Support Catheter (Soft TOrqueable catheter For Intracranial Access) has received FDA 510(k) clearance for transradial access in addition to transfemoral access. The unique design of the SOFIA EX 5F Catheter allows for great trackability and a large inside lumen provides a fast and effective way for tracking to intracranial locations in patients. Reinforced with a nitinol coil and stainless-steel braid, SOFIA EX offers support and kink resistance. The catheter has an inner PTFE liner throughout the entire length with 12 transition zones optimized for pushability.

Transradial access utilizes the radial artery in the wrist as opposed to the femoral artery in the groin in transfemoral access. The SOFIA EX 5F radial access clearance proudly marks MicroVention’s first radial access product and signifies our commitment to innovation. MicroVention believes providers should have the ability to feel confident in our SOFIA EX 5F in either the transradial or transfemoral access approach.

“We are pleased to receive FDA clearance for MicroVention’s SOFIA EX 5F Intracranial Support Catheter for transradial access,” said Carsten Schroeder, CEO, MicroVention. “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.”