Rist Neurovascular Gets 510(k) Clearance for Radial Artery Catheter

The FDA cleared Rist Neurovascular’s Rist Cath radial access long sheath device, a catheter that accesses the neurovasculature through the wrist’s radial artery.

The American Heart Association has recommended a radial-first strategy for treatment of acute coronary syndrome since 2018, but the Rist Cath is the first device cleared specifically for neurointerventional procedures.

The catheter is “the first device specifically designed for the unique demands of accessing the neurovasculature through the radial artery in the wrist, enabling the full gamut of neurovascular procedures to be performed transradially,” the company said.