Time is waiting for no one, nor, apparently, for Medtronic, which is moving forward with its plan to make one of its most recently acquired device portfolios available to the world.
Barely a year after Rist’s radial access catheter technology debuted in the operating room in Chicago last September, Medtronic has gradually expanded its availability across the United States and, now, with a freshly CE marked. hit, will also bring the devices abroad.
The European approval covers the Rist 079 Radial Access Guiding Catheter and the Radial Selective Access Catheter, both licensed for use to insert interventional devices into peripheral, coronary and cerebral blood vessels. The latter can also be used to transport diagnostic agents in the neurovascular system.
Catheters were the first designed specifically to be used to access the neurovascular system through the radial artery in the wrist rather than through the femoral artery in the groin. The radial artery is now the entry point of choice for cardiologists targeting the veins and arteries of the heart, after studies have shown that this method not only results in less bleeding, less complications and a longer recovery time. fast, but is also preferred by patients and lowers clinical costs.
All of these factors prompted neurologists to start taking the transradial approach in their own procedures to reach veins and nerves in the brain, which in turn led to Medtronic’s rapid commercialization of its specially designed catheters. effect.
RELATED: Medtronic Begins European Deployment of Drug-Coated Balloon Catheter to Treat Clogged Arteries
Rist catheters have a flexible end that is twice as long as catheters intended to be inserted into the femoral artery, which makes it easier to bend around the curves of the radial path. Conversely, the support section behind the flexible part is more rigid than those of transfemoral catheters, giving surgeons more stability as they weave the device through the arm and torso to the brain.
Catheters have so far been used in more than 100 procedures in the United States, according to Medtronic. Once the CE mark is obtained, they will now be available in the UK, Italy, Spain, Germany and France.
“We are committed to exploring ways to improve outcomes by reducing complications, lowering the cost of care and improving the overall patient experience. We believe that radial access is a significant addition to the clinical arsenal ”, noted Dan Volz, president of the neurovascular therapies business at Medtronic.
The European approval comes about a year and a half after the FDA issued a 510 (k) authorization 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 availability of catheters in the United States, financial terms of the deal were not disclosed.
RELATED: Medtronic Purchases Implanted Infusion Pump Technology to Develop New Treatment for Type 1 Diabetes
Rist was Medtronic’s eighth acquisition in 2020. While this buying spree has certainly slowed down in 2021, it has yet to come to a complete stop. Last month, Medtronic spent $ 1.1 billion to purchase Intersect ENT, a maker of steroid-eluting implants to treat chronic rhinosinusitis.
And, earlier this month, she struck 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, more alternative. lightweight and more precise than current insulin pumps.