FDA Allows Clot Retrieval Devices

Stroke kills nearly 130,000 Americans each year and is the fifth leading cause of death, according to CDC. About 87 percent of all strokes are ischemic strokes but up until now, the only first-line treatment for acute ischemic stroke was t-PA administered intravenously.

FDA www.fda.gov now allows the marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties, and other stroke disabilities. These devices should be used within six hours of symptom onset and following treatment with t-PA which needs to be given within three hours of symptom onset.

Trevo manufactured by Concentric Medical Inc., a company acquired by Stryker Corporation www.stryker.com, is a clot removal device that can be inserted through a catheter up into the blood vessel to the site of the blood clot.

When the shaped section at the end of the device is fully expanded up to three to six millimeters in diameter, it grips the clot. This enables the physician to retrieve the clot by pulling it back through the blood vessel along with the device which is then removed through a catheter or sheath.

The FDA evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device along with t-PA and medical management of blood pressure and disability symptoms plus 249 patients that had only t-PA and medical management tested.

Twenty nine percent of patients treated with the Trevo device were functionally independent three months after their stroke, as compared to 19 percent of the patients not treated with the Trevo device.

“This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone’, said Carlos Pena, PhD, Director, Division of Neurological and Physical Medicine Devices at FDA’s Center for Devices and Radiological Health.

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