Medtronic's newly acquired radial artery catheters go global with European approval

Medtronic headquarters
Two radial artery access catheters, developed by Medtronic’s recent acquisition Rist Neurovascular, are designed specifically for use in accessing the brain's inner blood vessels through the wrist rather than through the groin’s femoral artery. (Medtronic)

Time waits for no man—nor, apparently, for Medtronic, which is zooming ahead in its plan to make one of its most recently acquired device portfolios available around the world.

Barely a year after the Rist radial access catheter technology made its operating room debut in Chicago last September, Medtronic has progressively expanded its availability across the U.S. and, now, with a freshly minted CE mark, will also bring the devices overseas.

The European approval covers the Rist 079 Radial Access Guide Catheter and the Radial Access Selective Catheter, both of which are cleared for use in inserting interventional devices into the peripheral, coronary and brain blood vessels. The latter can also be used to transport diagnostic agents into the neurovascular system.

The catheters are the first designed specifically for use in accessing the neurovasculature by way of the radial artery in the wrist rather than the groin’s femoral artery. The radial artery is now the entry point of choice for cardiologists aiming for the heart’s veins and arteries, after studies have proven this method not only results in less bleeding, fewer complications and a faster recovery time but is also preferred by patients and reduces clinical costs.

All of these factors have inspired neurologists to begin adopting the transradial approach in their own procedures to reach the veins and nerves in the brain—which has, in turn, led to Medtronic’s rapid commercialization of its catheters designed for just that purpose.

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The Rist catheters feature a flexible end that’s two times longer than that of catheters meant to be inserted through the femoral artery, making it easier to bend around the curves of the radial pathway. Conversely, the supportive section located behind the flexible portion is stiffer than those in transfemoral catheters, giving surgeons more stability as they weave the device through the arm and torso to the brain.

The catheters have so far been used in more than 100 procedures in the U.S., according to Medtronic. With the CE mark secured, they’ll now be available in the U.K., Italy, Spain, Germany and France.

“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 Medtronic’s neurovascular therapies business.

The European approval comes about a year and a half after the FDA doled out a 510(k) clearance to the technology in February 2020. At the time, it was the flagship product of Rist Neurovascular, which was acquired by Medtronic last August, the medtech giant revealed earlier this year when it began expanding the catheters’ availability throughout the U.S. Financial terms of the deal weren’t disclosed.

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Rist was Medtronic’s eighth acquisition of 2020. While that shopping spree has certainly slowed down in 2021, it has yet to come to a complete halt. Just last month, Medtronic laid down $1.1 billion to purchase Intersect ENT, maker of steroid-eluting implants aimed at treating chronic rhinosinusitis.

And, earlier this month, it set up a deal with the Alfred E. Mann Foundation for Scientific Research to purchase the intellectual property rights to implanted infusion pump technology that could ultimately become a smaller, lighter and more precise alternative to current insulin pumps.