The device's approval is the first of 2018 for Medtronic, who received agency clearance for 9 devices in last year.
Dublin, Ireland-based device company Medtronic today announced US Food and Drug Administration (FDA) clearance of its Riptide Aspiration System, a product that can restore blood flow to the brain during acute ischemic stroke.
The system is designed to retrieve thrombus through Medtronic’s Arc Catheter. Procedurally, this involves inserting the catheter through an incision in the leg and up to the blocked artery, which allows a physician to remove the blood clot.
Specifically, the Riptide Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset. 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.
“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,” said Daniel Sahlein, MD, assistant professor of clinical neurology in the department of Neurological Surgery at Indianapolis University-Purdue University Indianapolis. “The Riptide Aspiration System will provide me with another proven…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.
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