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January 16, 2018 — Medtronic plc announced the company’s Neurovascular business unit received U.S. Food and Drug Administration (FDA) clearance of the Riptide Aspiration System, adding a tool to its acute ischemic stroke (AIS) product portfolio.

The Riptide Aspiration System is designed to retrieve thrombus (blood clot) through the Arc Catheter and restore blood flow in patients experiencing blockage of an artery in the brain, known as an ischemic stroke. The procedure involves inserting a catheter through an incision in the leg and up to the blocked artery, allowing the physician to remove the blood clot.

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 eight hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

“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,” said Daniel Sahlein, M.D., interventional neuroradiologist, Goodman Campbell Brain and Spine, assistant professor of clinical neurology in the Department of Neurological Surgery, Indianapolis University-Purdue University Indianapolis. “The Riptide Aspiration System will provide me with another proven Medtronic product to utilize when treating stroke patients.”

The Riptide Aspiration System includes the Arc Catheter, Riptide Aspiration Tubing, Riptide Aspiration Pump and Riptide Collection Canister with intermediate tubing. The Riptide Aspiration System is a foundational platform for future aspiration catheters, currently in development.

According to the American Heart Association/American Stroke Association (AHA/ASA), stroke is the fifth leading cause of death in the United States, and a leading cause of disability. In June 2015, the AHA/ASA published new stroke treatment guidelines that recommended 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.

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ELP allows FDA staff to conduct site visits with research, clinical, manufacturing and healthcare facilities to observe how medical devices are designed, developed and utilized

July 17, 2019 — The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the 2020 Experiential Learning Program site visit proposal solicitation period. The 2020 Fall ELP submission period is open from Monday July 8, 2019 – Thursday, August 8, 2019, at 12 p.m. EST. The ELP is intended to provide a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing and healthcare facilities to observe how medical devices are designed, developed and utilized.

The program has expanded to provide FDA staff with opportunities to better understand policies, laboratory practices, patient input and quality system management. The ELP is a collaborative effort to enhance communication and facilitation of the medical device review process. CDRH said it is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advance the development and evaluation of innovative devices.

CDRH is inviting medical device companies, academia and healthcare facilities to participate in this formal training program. Details of the program can be found on the ELP website, which provides the background, current training needs and proposal submission process. The training needs will be updated twice a year, in February and July, with a solicitation period for stakeholders to submit training proposals.

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