FDA clears Route 92 Medical’s FreeClimb 54 reperfusion system

Route 92 Medical today announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system.

The FreeClimb54 system uses an aspiration catheter of the same name paired with a Tenzing 5 delivery catheter. The new system is part of the company’s growing portfolio of neurovascular devices designed to work as complete endovascular thrombectomy solutions for neurovascular interventions.

“Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, helping them maximize their opportunity to restore blood flow to the brain on their first attempt,” CEO Tony Chou said. “The FreeClimb 54 reperfusion system is an essential addition to our product portfolio, enabling clinicians to use our products to address a wider range of patient needs.”

Route 92 Medical’s FreeClimb 54 system can telescope through the company’s complementary products to allow physicians to rapidly and predictably reach and remove …

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FDA clears stroke treatment system from Route 92 Medical

The FreeClimb 70 Reperfusion System. [Image courtesy of Route 92 Medical]Route 92 Medical announced that it received FDA 510(k) clearance for its FreeClimb 70 reperfusion system for treating ischemic stroke.

San Mateo, California-based Route 92 designed the reperfusion system with the FreeClimb 70 aspiration catheter. It also features a Tenzing 7 delivery catheter.

The system enables physicians to treat patients experiencing acute ischemic stroke by removing clots rapidly and safely. Route 92 said it offers a more refined bi-axial approach for restoring blood flow to the brain during endovascular thrombectomy procedures.

Dr. James Caldwell, an early user, said the system offers easily delivery to the target occlusion for effective, safe reperfusion. Caldwell used the system at Auckland City Hospital in Auckland, New Zealand.

“Tenzing-based delivery can reduce procedure time and may reduce complications,” Caldwell said.…

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Route 92 Medical raises $111M for its aspiration catheter to treat strokes

Route 92 Medical this week said it raised over $110 million in a combined Series E and debt financing round.

Capital raised included $56 million in a Series E financing round led by new investors InnovaHealth Partners and Norwest Venture as well as existing investors The Vertical Group and U.S. Venture Partners. Runway Growth Capital complemented the equity financing round with an up to $550 million senior secured term loan, according to Route 92 Medical.

Get the full story on our sister site, Medical Tubing + Extrusion.

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