Devices & Diagnostics

Medtech startups should look at ischemic stroke as area of unmet need

Medical device startups have a huge opportunity in developing devices to treat ischemic and even hemorrhagic stroke and stand to win reimbursement with good clinical and economic evidence.


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Medtech startups have a huge opportunity in developing devices to treat ischemic and even hemorrhagic stroke, and will likely gain reimbursement for these treatments if they can prove efficacy and economic sense.

That was the consensus by a panel of industry veterans at the Medtech Conference held this week in Minneapolis. Clinical trials begun in the past few years have demonstrated the efficacy of endovascular coil treatment for ischemic (blood-clot-related) stroke. For example, Stryker’s DAWN trial compared mechanical thrombectomy using the company’s Trevo Retriever plus medical therapy, versus medical therapy alone, when initiated within six to 24 hours of stroke onset. Enrollment in DAWN was halted early because the benefits became obvious.

A study published in the journal Stroke found that treatment of ischemic stroke with Medtronic’s Solitaire stent retriever, when combined with the clot-busting drug tPA, had immediate and long-term savings and gains in both life expectancy and quality of life when compared to intravenous tPA treatment alone.

Having the American Heart Association and American Stroke Association include endovascular treatment for acute ischemic stroke in their 2015 guidelines also has helped the cause of encouraging new and better treatment, said Brett Wall, president of brain therapies for Medtronic. With 17 million strokes occurring each year —15 million of them ischemic — the need for more treatment better access to high-quality treatment is dramatic, Wall said.

As an example, he pointed to the experience of a fellow employee’s father who was driving in Oklahoma when he had a stroke. The man was transported to a hospital, but that hospital was incapable of providing endovascular treatment.

“That is what our real challenge is,” Wall said. “We have to address that particular issue because all of us should have that opportunity, and if it doesn’t happen here in this market, there’s very little chance of it happening in other markets.”

Sixty percent of today’s neurovascular market lies outside the United States, centering largely in Europe, according to Tom Wilder,  who was CEO of Sequent Medical Inc. until its acquisition by Terumo in 2016 for up to $380 million. Sequent is developing a new medical device for aneurysm embolization.

Hospitals in Europe are more likely than their American counterparts to have providers with ordinary skill levels providing a variety of very complex neurological procedures, Wilder added.

“There’s a constant demand for further enhancements, ease of use, and clinical applicability,” he said. “That’s going to be a source of future innovation in both hemorrhagic stroke and ischemic stroke.”

Medtech will probably develop technology to treat other areas of the brain, added George Wallace,  a partner in Intersect Partners, LLC, a medtech research and investment company.

“Most of the technology now is still probably considered first- or second-generation technology,” Wallace said. “I think you’re going to see devices that can go much more distally in the brain to treat disease and maybe treat with less complications. So I think there’s lots of opportunity there as well.”

Photo: Topp_Yimgrimm, Getty Images