Devices & Diagnostics

Stent-maker Silk Road Medical in the stroke prevention biz; raising $22.5 million

About half of all strokes could be caused by a narrowing of the carotid artery – the pipeline that ushers blood flow through the neck and to the brain. The Bay Area’s Silk Road Medical may have found a less-invasive way to increase the blood flow to the brain, using traditional stenting concepts but kicking ’em up a notch. […]

About half of all strokes could be caused by a narrowing of the carotid artery – the pipeline that ushers blood flow through the neck and to the brain. The Bay Area’s Silk Road Medical may have found a less-invasive way to increase the blood flow to the brain, using traditional stenting concepts but kicking ’em up a notch.

To do so, Silk Road has just raised $15 million from four investors as part of a $22.5 million round, according to regulatory filings. This brings total investment in the company, founded in 2007, to more than $50 million. The company has listed Warburg Pincus and The Vertical Group as its main investors, though more are clearly involved.

The company has got a “transcarotid stent” that’s equipped with what’s called dynamic flow reversal, a mechanism that protects the brain by temporarily redirecting blood flow away from the brain while the stent is being inserted. It also carries away debris that’s inadvertently created during the procedure, Silk Road said, trapping it in a filter outside the body.

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And Silk Road’s less-invasive device allows doctors to insert a stent directly from the neck, as opposed to the femoral artery in the groin – thus avoiding complications associated with working through extra piping in the body.

“That leaves you, as we say, with about three feet less of adventure” through some hairpin curves in the artery, CEO Erica Rogers told Ron Leuty at the San Francisco Business Times in April. Leuty describes the stent insertion process nicely:

With the river of blood in reverse, doctors can place across the lesion a stent that serves as a sort of scaffold. The vessel then is gently pushed open, creating a channel about the size of a slim pen or pencil, and the stent holds it open.

The company last month completed enrollment of its “ROADSTER” clinical trial, which will provide the data needed to receive 510(k) clearance from the FDA. It’s already received testing clearance in many European countries, the company said. It expects to report data from the trials early next year.