Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist 079 radial access guide catheter—the first catheter specifically designed for the unique demands of accessing the neurovasculature to treat stroke, brain aneurysms and other conditions through the radial artery versus access through the transfemoral artery, according to a company press release.
The Rist 079 radial access guide catheter is 510(K) cleared by US Food and Drug Administration (FDA) and has been in use at limited sites in the USA, receiving strong customer feedback in more than 100 cases on its outperformance in navigability and support for the radial pathway, the release adds.
“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 Alejandro Tomasello, head of the Interventional Neuroradiology Unit at Vall d’Hebron Hospital in 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 the Pipeline Vantage embolisation device with Shield technology treatments [all Medtronic].”
Transradial techniques have been the standard of care in the cardiac interventional community since the American Heart Association (AHA) 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 neurointerventionist community to examine adoption of the transradial approach to their practice, the release also states.
“We are committed to exploring ways to improve outcomes through complication reduction, reducing the cost of care and improving overall patient experience,” said Dan Volz, president of the Neurovascular Therapies business, which is part of the Neuroscience Portfolio at Medtronic. “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.”