MIAMI BEACH, Fla.--(BUSINESS WIRE)--RIST Neurovascular, Inc., a neuro-interventional medtech company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the RIST Cath Radial Access Long Sheath™ (RIST Cath) for the introduction of interventional devices into the peripheral, coronary, and neurovascular system. RIST Cath 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.
“Although transradial techniques have become the standard of care in the cardiac interventional communities, neurointerventionalists have not previously had the appropriate tools to allow these advantages for patients undergoing neurovascular procedures,” said Pascal M. Jabbour, MD, Professor of Neurological Surgery and chief of the Division of Neurovascular and Endovascular Neurosurgery in the Department of Neurological Surgery at the Sidney Kimmel Medical College at Thomas Jefferson University. “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.”
“The RIST Cath was developed to meet a well-documented need expressed among physicians conducting neurovascular surgeries,” said Martin Dieck, Director, RIST Neurovascular. “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.”
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While the American Heart Association has recommended a radial-first strategy for acute coronary syndrome since 2018, there has never before been a FDA cleared device that enabled the use of this strategy specifically for neurointerventional procedures.
Cardiology studies have demonstrated a significant reduction in access site complications as well as mortality with radial access. Furthermore, radial access procedures offer several additional advantages, including strong patient preference, immediate ambulation, and reduced costs.
At the International Stroke Conference 2020, being held in Los Angeles, California February 18 – 21, there will be several presentations exploring the benefits of radial access for neurointerventional Surgery.
About RIST Neurovascular, Inc.
Founded in 2018, RIST Neurovascular, Inc is focused on creating a portfolio of access products designed to allow neuroendovascular procedures to be performed via the radial artery.