Friday, September 22, 2023
MicroVention, a global leader in the neurovascular field and a wholly-owned subsidiary of Terumo Corporation, has exciting news to share. They have received FDA 510(k) clearance for the SOFIA™ EX 5F 115cm Intracranial Support Catheter, known for its Soft TOrqueable design for Intracranial Access, to be used in transradial access, in addition to its existing clearance for transfemoral access.
The innovative design of the SOFIA™ EX 5F Catheter allows for superior trackability, thanks to its spacious inner lumen, which streamlines navigation to intracranial locations in patients. The catheter is fortified with a nitinol coil and stainless-steel braid, ensuring robust support and exceptional resistance to kinking.
Transradial access, a method that utilizes the radial artery in the wrist rather than the femoral artery in the groin, offers an alternative approach for medical procedures. The FDA's clearance for MicroVention's SOFIA™ EX 5F for radial access signifies a noteworthy achievement, marking MicroVention's debut product tailored for radial access and underscoring their commitment to innovation.
MicroVention aims to empower healthcare providers by providing them with the confidence to utilize the SOFIA™ EX 5F catheter, whether they opt for transradial or transfemoral access. This FDA clearance reaffirms the adaptability and reliability of MicroVention's SOFIA™ EX 5F Intracranial Support Catheter for transradial access.
Source: businesswire.com
