FDA approves Concentric Medical’s Trevo clot retrievers

The FDA said today it granted expanded approval to 2 Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.

The indications expand the previously won clearance for the devices, won in 2012, which cleared the retrievers for removing blood clots and restoring blood flow in stroke patients who could not receive t-PA or for patients who didn’t respond to t-PA therapy.

“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. Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability,” FDA Center for Devices and Radiological Health neurological and physical medicine devices division director Carlos Peña said in a press release.

The Trevo is a transcatheter clot removal device designed to retrieve blood clots by gripipng at the clot and pulling it back through the blood vessel along with the device, according to an FDA release.

Approval came based on data from a clinical trial of the device along with t-PA and medical management of blood pressure and disability symptoms which found that 29% of patients treated with the Trevo device were functionally independent at 3 months, 10% higher than those not treated with the device.

Stryker picked up Concentric Medical in 2011 for $135 million.

The post FDA approves Concentric Medical’s Trevo clot retrievers appeared first on MassDevice.

from MassDevice http://ift.tt/2cwvqOC