Rist Neurovascular announced today that it won FDA 510(k) clearance for its Rist Cath radial access long sheath for accessing the neurovasculature through the radial artery in the wrist.
The Miami Beach, Fla.–based company touts the Rist Cath as the first device specifically designed to access the neurovasculature through the radial artery, which could open up the possibility of performing a number of neurovascular procedures transradially, according to a news release.
According to Rist Neurovascular, the American Heart Association has recommended a radial-first strategy to treat acute coronary syndrome since 2018. However, the Rist Cath is the first FDA-cleared device to enable that strategy in neurointerventional procedures.
According to Dr. Pascal Jabbour, chief of neurovascular & endovascular neurosurgery at the Sidney Kimmel Medical College at Thomas Jefferson University, transradial techniques are standard-of-care in cardiac intervention, but the tools haven’t been available for neuroinverventionalists.
“Clearance of the Rist Cath provides neuroendovascular specialists a safe and durable tool to perform neuroendovascular interventions via a transradial approach, and allows us to offer improved care for patients while pushing the envelope of what our field has to offer,” Jabbour said in the news release.
“The Rist Cath was developed to meet a well-documented need expressed among physicians conducting neurovascular surgeries,” added Rist Neurovascular director Martin Dieck. “This FDA clearance will allow us to make the Rist Cath broadly available to these surgeons, improving care for the millions of patients undergoing procedures to treat conditions such as stroke, brain aneurysms and other neurovascular conditions.”