FDA Clears Medtronic's Riptide Aspiration System for Treatment of Acute Ischemic Stroke

January 16, 2018—Medtronic announced that the company’s neurovascular business unit received US Food and Drug Administration clearance for its Riptide aspiration system, which joins the Solitaire revascularization device in Medtronic's portfolio of devices for treating acute ischemic stroke.

According to the company, 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 the internal carotid, middle cerebral [M1 and M2 segments], basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for, or who fail, intravenous tissue plasminogen activator therapy are candidates for treatment.

The Riptide aspiration system's Arc catheter retrieves thrombus. The system is also composed of aspiration tubing, an aspiration pump, and collection canister with intermediate tubing. The Riptide aspiration system is a foundational platform for future aspiration catheters that are currently in development, noted the company.

In Medtronic's announcement, Daniel Sahlein, MD, commented, “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. The Riptide aspiration system will provide me with another proven Medtronic product to utilize when treating stroke patients.” Dr. Sahlein is an interventional neuroradiologist at Goodman Campbell Brain and Spine and Assistant Professor of Clinical Neurology in the Department of Neurological Surgery, Indianapolis University-Purdue University Indianapolis in Indiana.