Medtronic ($MDT) launched the Arc support catheter, enabling faster delivery of the Solitaire Stent retriever to treat ischemic stroke patients by physically removing the clot and restoring blood flow in the brain's arteries.
"The Arc support catheter establishes a new level of navigation performance for our most challenging patients," said Satoshi Tateshima, professor of neuro-interventional radiology at the University of California, Los Angeles (UCLA), in a statement. "When combined with Medtronic's Solitaire stent retriever, this new system allows physicians to treat more challenging acute ischemic stroke patients and helps broaden our ability to service a larger segment of the population who suffer from this disease."
The device was FDA-cleared in July 2015 for the introduction of interventional devices into the peripheral and neurovascular. The agency deemed the Arc "substantially equivalent" to the ReFlex guide catheter, also made by Medtronic.
According to the clearance notice, the Arc has longer lengths for improved navigability and also has "improved trackability over guide wire to smaller vessels" when compared to the ReFlex.
Thus, the Arc should result in improved deliverability of the Solitaire stent.
Medtronic inherited the Solitaire with its $50 billion acquisition of Covidien. It is now one of the company's biggest growth opportunities due to recent evidence supporting the use of devices to treat stroke, in addition to drugs.
About a third of the 695,000 U.S. acute ischemic stroke victims are eligible for treatment with a stent retriever, but only about 13,000 procedures are performed annually, Medtronic says. An increase in procedures to a large extent depends on the medical community improving and expanding its stroke care infrastructure, such as the development of new comprehensive stroke centers, where the specialized devices are deployed.
Time is a critical component of the burgeoning field of stent thrombectomy, making the launch of the new delivery catheter significant. In fact, the latest guidelines from the American Stroke Association say the benefits of endovascular therapy (which involves the use of devices to physically remove a blood clot in the brain) are uncertain if endovascular therapy is initiated more than 6 hours after a stroke occurs.
But the guidelines are clear about the benefits of stent retrieval devices if they are deployed quickly, based on 5 influential large randomized studies published in the New England Journal of Medicine. The benefits of the devices were so clear that some of the trials had to be stopped early for ethical reasons out of consideration for those randomized into the drug-only early group.
The Solitaire was the only model to be used in all 5 trials, including exclusive use in all three, though the American Stroke Association guidelines do not endorse any particular model.
The Solitaire's biggest competitor is Stryker's ($SYK) Trevo ProVue retriever, which has a similar mechanism of action to Medtronic's device. They entrap the clot in a stentlike structure.
Penumbra's Ace64 and Penumbra System use aspiration to suck the clot out in a manner similar to that deployed by a vacuum. The company launched a $120 million IPO today and cited momentum from one of the NEJM trials in an interview with FierceMedicalDevices.
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