510(k) Clearance For Stryker’s Trevo® Pro Clot Retrieval System

In short

Stryker Neurovascular has announced that its Trevo® Pro Retriever has been granted FDA 510(k) market clearance. The Trevo® Pro Retriever is Stryker’s next generation clot removal device and utilises the company’s proprietary Stentriever® Technology for optimised clot integration and retrieval in patients experiencing acute ischemic stroke.

Background

The Trevo® Pro Retriever demonstrated strong clinical results in the TREVO 2 clinical trial presented at the 2012 European Stroke Conference in May. This technology demonstrated the highest rate of revascularisation in a randomised embolectomy stroke device trial, and achieved significantly better post-procedure revascularisation than the company’s Merci Retriever®, as we reported at the time. Other measures of performance also strongly favored the Trevo® Pro Retriever, including improvement in the National Institutes of Health Stroke Scale (NIHSS) score, excellent composite safety endpoints and shorter hospital stays.

Clinician comments

“The launch of this device is another great stride in the evolution of stroke care,” said TREVO 2 Investigator Gary Duckwiler, MD at University of California Los Angeles Medical Center. “Concentric Medical, which is now owned by Stryker, has a long history of partnering with physicians to develop devices specifically designed to remove blood clots from a blocked artery in the brain.  The new Trevo®  Pro Retriever is easy to use and very effective at opening blood vessels; allowing physicians to have a significant impact on clinical outcomes.”

“In this patient population, rapidly restoring blood flow to the brain is critical,” said Neurologist Wade Smith, MD at the University of California San Francisco Medical Center.  “This technology advances our ability to help many patients avoid the devastating effects from a large stroke if they can get to a comprehensive stroke center quickly for treatment.”

Company comments

“Our mission is to advance complete stroke care for patients worldwide.  In doing so, we are committed to providing innovative, new technologies, along with robust clinical evidence to expand the field,” said Mark Paul, President of Stryker’s Neurovascular division. “As we saw with the TREVO 2 data, this technology is helping physicians and patients, and we are very excited to be able to facilitate advances in medical care with game-changing technology like the Trevo Pro Retriever.”

Source: Stryker