FDA Clears Medtronic's Riptide Clot Aspiration System

FDA Clears Medtronic's Riptide Clot Aspiration System

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Riptide aspiration system (Medtronic) to retrieve blood clots and restore blood flow in patients with acute ischemic stroke, the company has announced.

In a news release, Medtronic said the Riptide system is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large-vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset.

Patients who are ineligible for intravenous tissue plasminogen activator (IV tPA) or in whom IV tPA therapy fails are candidates for treatment.

The complete Riptide aspiration system includes the Medtronic Arc Catheter, Riptide Aspiration Tubing, Riptide Aspiration Pump, and Riptide Collection Canister with intermediate tubing. “The system is a foundational platform for future aspiration catheters, currently in development,” the company said.

Commenting on the Riptide approval in the release, Daniel Sahlein, MD, interventional neuroradiologist at Goodman Campbell Brain & Spine in Indianapolis, Indiana, said, “While I primarily use the Solitaire revascularization device [Medtronic] to treat patients with acute ischemic stroke, I utilize a direct aspiration approach as my first line treatment strategy in select circumstances such as basilar artery thromboembolism and in select anterior circulation cases.”  

In 2015, as reported by Medscape Medical News, the American Heart Association/American Stroke Association updated its guidelines on endovascular treatment for acute ischemic stroke — strongly recommending its use in certain patients — on the basis of the influx of new clinical trial data that had recently become available.

Results of the ASTER trial, presented at the International Stroke Conference 2017, using another aspiration device (Penumbra) showed that outcomes with first-line use of aspiration in ischemic stroke were similar to outcomes achieved with the stent retriever.

The COMPASS trial, comparing first-line use of any approved aspiration device vs any approved stent retriever, is ongoing, with results expected later this year.

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