New studies show that devices, not just drugs, can help treat strokes

Print 13 February 2015
Varun Saxena / FierceMedicalDevices

Groundbreaking studies that resulted in standing ovations at the International Stroke Conference in Nashville, TN, offered more evidence that revascularization devices that physically remove blood clots from the brain are a valuable and potentially lifesaving addition to pharmaceutical therapy in stroke patients.

Will the findings lead to widespread adoption of the devices? They are not used at many comprehensive stroke centers in the U.S. due to the need for radiological scans and other surgical resources.

"There are a great many centers that will report they have the capability to provide these services," Dr. Jay Mocco, director of the Cerebrovascular Center at Mount Sinai Health System in New York City, told the LA Times. "But there are truthfully relatively few that have put in the effort and expertise to create the comprehensive team-based work flow needed to rapidly evaluate and treat these patients safely and efficiently (via surgery)," he said.

Mocco believes the study results are "radically better than anything we've had." In fact, both studies in the New England Journal of Medicine showed the benefits to be so obvious that they were stopped early. The Escape study of 316 participants in Australia and New Zealand found that 71% of stroke patients in the treatment arm returned to functional independence and had a lower risk of death, compared to 40% of patients who received standard of care medication only (known as IV-tPA).

The other, dubbed Extend-Ia, also found a higher rate of return to functional independence in the treatment arm, by an identical 71% of stent thrombectomy blood clot removal surgery patients versus 40% in the drug-only control arm.

Solitaire FR Revascularization device--Screenshot courtesy of Covidien

Covidien helped to fund the trials, which used the company's Solitaire FR Revascularization device. The device uses a guide wire to position a microcatheter on either side of the clot. Then the mesh Solitaire FR is deployed and the microcatheter is withdrawn. Lastly, the Solitaire FR and microcatheter are withdrawn as a unit, along with the blood clot, which is trapped in the mesh, explains a company video.

Covidien's new owner, Medtronic ($MDT), touted the study results. The company said the Solitaire offers a treatment option for patients who are ineligible for the pharma treatment because they have missed the three-hour treatment window or their stroke is too severe.

"The strength of the data for Solitaire speaks for itself. The data presented today suggest remarkable benefits from stent thrombectomy," said Brett Wall, the president of Medtronic's neurovascular division, in a release. "The need for this device in the treatment of stroke is clear."

The latest data builds on the Mr. Clean study of Covidien's Solitaire and Stryker's ($SYK) Trevo ProVue Retriever, which found that stent retrievers are almost twice as successful as pharmaceuticals alone.

These results contradict previous studies in the New England Journal of Medicine that did not find any additional benefit to stroke-fighting devices.

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