FDA Expands Treatment Window for Stryker’s Clot Retrieval Device in Stroke Patients

The FDA cleared the use of Stryker’s (NYSE: SYK) Trevo Retriever as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from symptom onset, increasing the approved treatment window by 18 hours and thereby expanding the device’s indication to a broader group of patients. Trevo is cleared for use as an initial therapy for strokes due to blood clots (acute ischemic stroke) to reduce paralysis, speech difficulties and other stroke disabilities and only as an addition to treatment with tissue plasminogen activator (t-PA), a medication that dissolves blood clots.

Trevo is a clot removal device that is inserted through a catheter up into the blood vessel to the site of the clot. When the shaped section at the end of the device is fully expanded (up to 3mm to 6mm in diameter), it grips the clot, enabling the physician to retrieve it by pulling it back through the blood vessel along with the device for removal through a catheter or sheath. Trevo was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. The FDA expanded the permitted marketing of the device in 2016 to certain patients in addition to treatment with t-PA if used within six hours of the onset of symptoms. Today’s expanded indication increases the amount of time that the device can be used from 6 hours to 24 hours.

Source: Stryker

The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities. These patients now have a much better chance for an independent life without disability.

– Raul Nogueira, MD, Director, Neuroendovascular Division, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital and Professor of Neurology, Neurosurgery and Radiology at Emory University School of Medicine.

The FDA’s expanded indication was based on recent clinical data showing that patients presenting in the six to 24-hour window who meet specific imaging criteria and are treated with the Trevo Retriever are almost four times as likely to be functionally independent at 90 days post-stroke, compared to those treated with medical management alone.

Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment. Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.

– Carlos Peña, PhD, Director, Division of Neurological and Physical Medicine Devices, FDA’s Center for Devices and Radiological Health.

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