FDA Approves Riptide Aspiration System for Acute Ischemic Stroke

January 16, 2018

The FDA has approved the Riptide Aspiration System for thrombus retrieval via the Arc Catheter for revascularization in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease.

Daniel Sahlein, MD

The FDA has approved the Riptide Aspiration System for thrombus retrieval via the Arc Catheter for revascularization in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease, according to a statement from Medtronic, the company marketing the device.

According to a Medtronic statement, patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. In non-clinical animal testing the Riptide Aspiration System was compared with Penumbra System and Penumbra Pump MAX. According to an FDA review, the devices were found to be equivalent. No further testing was required by the FDA prior to approval.

The Riptide Aspiration System joins the Solitaire Platinum Revascularization Device, also manufactured by Medtronic. This device is indicated for thrombus removal for patients with acute ischemic stroke in patients with persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts. Additionally, the device is approved for removing thrombus from a large intracranial vessel in those with ischemic stroke within 8 hours of symptom onset.

“While I primarily use the Solitaire Revascularization Device 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,” Daniel Sahlein, MD, assistant professor of clinical neurology in the department of Neurological Surgery at Indianapolis University-Purdue University Indianapolis, said in a statement. “The Riptide Aspiration System will provide me with another proven Medtronic product to utilize when treating stroke patients.”

The complete Riptide Aspiration System contains the 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 system is in line with the June 2015 American Heart Association/American Stroke Association, which recommend the use of stent retriever technology — such as the Solitaire stent retriever device – in conjunction with IV rtPA/alteplase as a first-line treatment for eligible patients.

“Medtronic is committed to developing services and solutions that address healthcare needs by improving clinical and economic outcomes,” said Stacy Pugh, vice president and general manager of Medtronic’s Neurovascular business, part of the Restorative Therapies Group.

According to the company’s website, in 2017 Medtronic received FDA approval for 9 devices, and regulatory approval in Japan for at least 2 devices.

On January 9, the medical device manufacturer announced a restructuring program that is expected to trim costs by more than $3 billion in the next 4 years. It was unclear at the time of the announcement how many of the company's more than 9,000 employees would be affected by the change, but Medtronic did say their employee count would remain the same in an SEC filing.