Device maker wins award for Best Medical Technology

Device maker wins award for Best Medical Technology

A rendering illustrates Stryker’s Trevo ProVue Retriever device at work, removing blood clots in patients experiencing ischemic stroke. Courtesy Stryker

A medical device maker has earned the Galien Foundation’s award for Best Medical Technology for a first-of-its-kind device to help stroke victims.

Stryker in Kalamazoo received the Prix Galien USA award for its Trevo ProVue Retriever, which is designed to restore blood flow in the neurovasculature, by removing blood clots in patients experiencing ischemic stroke.

"We are thrilled to be recognized by the Galien Foundation and honored to be among such a prestigious group of recipients of this year's award," said Mark Paul, president, Global Neurovascular, Stryker.

Device for brain-artery clots

Stryker said the Trevo ProVue Retriever is the first and only Stentriever Device fully visible under fluoroscopic imaging and allows for precision placement and visualization of the device-clot interaction and clot retrieval. The enhanced level of visibility provides physicians with "real-time information not previously available."

In the U.S., there are an estimated 795,000 strokes every year. Of these, about 35 percent to 40 percent are considered “large vessel” ischemic strokes, resulting from a blood clot in one of the major arteries in the brain, according to Stryker. If left untreated, patient prognosis with this type of stroke is "very poor," with mortality rates as high as 86 percent.

Clot-busting alternative

The frontline medical therapy for ischemic stroke is the clot-busting drug IV tPA, which is administered intravenously, according to Stryker. Studies have shown that IV tPA has a maximum success rate of 44 percent in dissolving the clot in an intracranial large vessel occlusion.

For patients ineligible to receive IV tPA, or where IV tPA has been unsuccessful, Stryker said the Trevo ProVue Retriever offers a minimally invasive surgical option for removing the clot.

The medical device maker said the Trevo 2 Trial, a prospective, randomized trial, has shown re-vascularization rates of up to 92 percent with the device. High re-vascularization rates and ease of use have resulted in the "rapid adoption" of the Trevo ProVue Retriever. With an expanded physician use base, hospitals around the world are "now increasingly able to offer this medical treatment for ischemic stroke."

The product was granted 510(k) market clearance by the U.S. Food and Drug Administration in 2012.

“We strive to introduce innovative medical technologies that can help improve patient outcomes,” Paul said. “The Trevo ProVue Retriever represents a truly innovative medical product and one that has brought about a new era in ischemic stroke management and intracranial clot retrieval.”

The award

The Galien Foundation’s Prix Galien USA 2014 award for Best Medical Technology is an international award recognizing outstanding achievements in improving the human condition through the development of innovative therapies. It recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines.

The foundation said that the Prix Galien is regarded worldwide as "the equivalent of the Nobel Prize in biopharmaceutical research."

Stryker was honored on Oct. 28 at the eighth annual Prix Galien Awards Gala, held at the American Museum of Natural History in New York City.