Fridley, Minn.-based Medtronic said the Arc catheter won 510(k) clearance from the FDA in July.
“The Arc support catheter will complement our Solitaire stent retriever and demonstrates our organization’s focus on the treatment of stroke,” neurovascular president Brett Wall said in prepared remarks. “The device also represents our organization’s ability to continue to deliver innovative technology.”
“The Arc support catheter establishes a new level of navigation performance for our most challenging patients,” added Dr. Satoshi Tateshima of the University of California, Los Angeles. “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.”
Solitaire was the primary device studies in a bevy of trials that prompted the American Heart Assn./American Stroke Assn. this summer to revise its stroke treatment guidelines to include endovascular thrombectomy devices like stent retrievers.
Although the medical society said optimal treatment still lies with the intravenous use of tissue plasminogen activators to break down clots, the group recommended the use of retrieval devices in cases where tPA fails to relieve the obstruction.
“What we’ve learned in the last 8 months, from 6 new clinical trials, is that some people will benefit from additional treatment with a stent retrieval device if a clot continues to obstruct one of the big vessels after tPA is given,” Dr. William Powers of the University of North Carolina at Chapel Hill, lead author of the updated guidelines, said at the time.
The update suggested a preference for stent retrievers over other mechanical thrombectomy devices, but adds that the use of other devices may be reasonable based upon a physician’s clinical judgement.