Medtronic Receives CE Mark Approval for Radial Artery Access Portfolio

Wednesday, September 29, 2021

Medtronic plc, the global leader in medical technology, today announced it has received CE Mark approval for its radial artery access portfolio, which includes the Rist™ 079 Radial Access Guide Catheter and Rist™ Radial Access Selective Catheter.

The Rist 079 Radial Access Guide Catheter is the first catheter specifically designed for the unique demands of accessing the neuro vasculature through the radial artery versus access through the transfemoral artery. 510(K) cleared by United States Food and Drug Administration1, the product has been in use at limited sites in the U.S. and received strong customer feedback in over 100 cases on its outperformance in navigability and support for the radial pathway.

"With excellent navigability, this first-of-its-kind device will allow clinicians to reach distal locations while still achieving excellent stability to the system," said Dr. Alejandro Tomasello, head of Interventional Neuroradiology Unit at Vall d'Hebron Hospital, Barcelona, Spain. "The radial artery-access portfolio works well in tandem with Phenom™ PLUS, Phenom™ 021 microcatheter for stent deployment or Phenom™ 027 microcatheter for flow diverter deployment, which is a fantastic set up for Pipeline™ VANTAGE Embolization Device with Shield Technology™ treatments."

Transradial techniques are now the standard of care in the cardiac interventional community since the American Heart Association(opens new window) recommended a radial-first approach for acute coronary syndrome in 2018 citing lower bleeding and vascular complications than transfemoral artery access2,3. Other advantages demonstrated in cardiovascular procedures to radial access include strong patient preference4, immediate ambulation and reduced costs5,6, which have led the neuro-interventionalist community to examine adoption of the transradial approach to their practice.

"We are committed to exploring ways to improve outcomes through complication reduction, reducing the cost of care and improving the overall patient experience. We believe radial access is a meaningful addition to the clinical armamentarium," said Dan Volz, president of the Neurovascular Therapies business, which is part of the Neuroscience Portfolio at Medtronic. "The CE Mark approval of the Rist radial access portfolio emphasizes our focus on driving innovation that gives clinicians who perform neurovascular procedures the broadest product portfolio so they can customize their care based on a patient's condition and anatomy."

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