UPDATED Sept. 7, 2016, with comment from Stryker
The FDA said today that it granted expanded approval to 2 of 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 previous clearances for the devices, won in 2012, which cleared the retrievers for removing blood clots and restoring blood flow in stroke patients who can’t be treated with tissue plasminogen activator 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.
“This expanded indication for Trevo is a significant milestone in the treatment of patients who are suffering from this catastrophic disease and is an example of the strength of evidence for the Trevo device coming from randomized clinical trials,” added Stryker neurovascular president Mark Paul.
“This new and unique indication for Trevo, as initial therapy for acute ischemic stroke with large vessel occlusions, has the potential to help hundreds of thousands of stroke patients,” Dr. Amrou Sarraj, of Houston’s University of Texas Health Science Center, said in prepared remarks. “These patients now have a significantly better chance for an independent life without disability.
“So many patients with major ischemic stroke due to large vessel occlusions still go untreated today, largely ending up with a devastating long term disability,” Sarraj said. “The FDA clearance of the Trevo retriever as a front-line treatment to reduce disability reinforces the importance that all caregivers in the stroke pathway – from EMS to emergency room physicians to neurologists to interventionalists – continue to come together to deliver fast and efficient treatment of stroke.”
Trevo is a transcatheter clot removal device designed to retrieve blood clots by gripping at the clot and pulling it back through the blood vessel along with the device, according to the FDA.
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.
