Medtronic receives CE mark for radial artery access portfolio

Medtronic 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 Administration, 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.

Riitta Rautio, M.D., Ph.D., adjunct professor, head of the Department of Interventional Radiology, Turku University Hospital, Finland, said: “Rist has been a game changer in the radial access. I don’t see radial access anymore as an alternative, but it is now the first choice in our daily practice in all kinds of neuro procedures. The Rist guide works perfectly with the Rist diagnostic catheters even in tortuous anatomy.”

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

Dan Volz, president of the neurovascular therapies business at Medtronic, said: “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. The CE mark approval of the Rist radial access portfolio emphasises our focus on driving innovation that gives clinicians who perform neurovascular procedures the broadest product portfolio so they can customise their care based on a patient’s condition and anatomy.”