Sam Brusco, Associate Editor09.21.23
Terumo subsidiary MicroVention has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its SOFIA EX 115 cm intracranial support catheter for transradial access, adding to its previous transfemoral access capability for neurovascular care.
The SOFIA EX 5F catheter, according to the company, allows great trackability and a large inside lumen for a quick, effective way to track intracranial locations. The catheter is reinforced with a nitinol coil and stainless-steel braid to provide support and kink resistance. An inner PTFE liner throughout the catheter length has 12 transition zones to optimize pushability.
Transradial access uses the wrist’s radial artery, rather than the groin as in transfemoral access. The clearance for transradial access with SOFIA EX 5F marks MicroVention’s first entry into the radial access market.
“We are pleased to receive FDA clearance for MicroVention’s SOFIA EX 5F Intracranial Support Catheter for transradial access,” MicroVention CEO Carsten Schroeder told the press. “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.”
Earlier in September, MicroVention introduced the ERIC laser-cut clot retriever for ischemic stroke treatment.
The SOFIA EX 5F catheter, according to the company, allows great trackability and a large inside lumen for a quick, effective way to track intracranial locations. The catheter is reinforced with a nitinol coil and stainless-steel braid to provide support and kink resistance. An inner PTFE liner throughout the catheter length has 12 transition zones to optimize pushability.
Transradial access uses the wrist’s radial artery, rather than the groin as in transfemoral access. The clearance for transradial access with SOFIA EX 5F marks MicroVention’s first entry into the radial access market.
“We are pleased to receive FDA clearance for MicroVention’s SOFIA EX 5F Intracranial Support Catheter for transradial access,” MicroVention CEO Carsten Schroeder told the press. “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.”
Earlier in September, MicroVention introduced the ERIC laser-cut clot retriever for ischemic stroke treatment.