Medtronic plc said Monday that it has expanded its limited site release of its new radial artery access portfolio. Acquired from Rist Neurovascular Inc. last year, the portfolio includes the Rist 079 Radial Access guide catheter and Rist Radial Access selective catheter.
Dublin-based Medtronic completed its acquisition of privately held Rist Neurovascular in August 2020 for an undisclosed sum – the eighth in a series of tuck-in deals the med-tech behemoth has undertaken since January 2020. Revenue and earnings from Rist are expected to have an immaterial impact on the neurovascular business in the first two years and be accretive thereafter.
The new catheters give Medtronic a broader breadth in serving patients who require interventional neurovascular therapy.
“The Rist Radial Access portfolio is an ideal strategic fit for Medtronic as our goal is to offer the most advanced, patient-preferred delivery tools to meet the needs of neurovascular professionals,” said Stacey Pugh, president of the neurovascular therapies business, which is part of Medtronic’s Restorative Therapies Group.
Under the initial phase of the rollout, the Rist catheter will be available at more than 120 sites in the U.S.
“We have completed more than 80 cases in our limited market release evaluation at 12 institutes and are very pleased with performance and physician feedback,” Pugh said.
Medtronic plans a full market release to all sites within the U.S. in its upcoming fiscal year, she told BioWorld. The company is also looking to expand its radial arterial portfolio with new offerings in the coming year.
Rist won 510(k) clearance for both the Rist 079 Radial Access guide catheter and selective catheter from the U.S. FDA last year. The Miami-based company touts the technology as the first specially designed to access the neovasculature through the radial artery, which could pave the way for performing a variety of neurovascular procedures transradially.
“Rist 079 Radial Access guide catheter is the first catheter that has been specifically designed for neurointerventions using the radial artery pathway in the wrist,” said R. Webster Crowley, chief of cerebrovascular and endovascular neurosurgery at Rush University Medical Center, who performed the first in-patient procedure in September. “This is the first-of-its-kind device that optimizes transition zones for the required navigability and support that is unique to the radial trajectory when compared to the femoral approach.”
Safer, less costly
Neurovascular interventions, such as treatment of brain aneurysm and cerebral angiogram testing, have traditionally been performed via the femoral artery in the groin. However, transradial procedures accessed through the arm are growing rapidly, as they have been shown to have similar outcomes but with less major bleeding and access site complications.
Transradial techniques offer additional benefits as well, Pugh told BioWorld. “Other advantages to radial access procedures include strong patient preference, immediate ambulation and reduced costs, which has led the neurointerventionalist community to examine adoption of the transradial approach to their practice.”
In 2018, the American Heart Association recommended a transradial approach to treat acute coronary syndrome, citing the strength of its safety profile compared with transfemoral artery access.
“The Rist Radial Access portfolio gives clinicians who perform neurovascular procedures the full spectrum of access and delivery devices that are optimized for the patient’s condition and anatomy,” Crowley said. “This should help improve the care we deliver to patients treated for neurovascular conditions.”
Support for radial access vs. a femoral approach has been building for years. In 2013, Eurointervention published a consensus document favoring this more efficient route to the heart when used by experienced practitioners. And in 2015, the European Society of Cardiology updated its guidelines to include a class I recommendation for transradial access during coronary interventions with level I evidence.