Medical technology company Route 92 Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its FreeClimb 70 Reperfusion System.
The system consists of a FreeClimb 70 Aspiration Catheter and a Tenzing 7 Delivery Catheter.
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Physicians can use the system to remove clots safely and quickly in patients who are suffering from acute ischemic stroke.
Route 92 Medical CEO Tony Chou said: “Route 92 Medical aims to provide neurovascular interventionists with innovative endovascular thrombectomy solutions, helping them maximise their opportunity to restore blood flow to the brain on their first attempt.
“The 510(k) clearance for the FreeClimb 70 Reperfusion System is a key addition to our portfolio of products that are designed to simplify removal of the embolus and seek to improve outcomes.”
The FreeClimb 70 Reperfusion System is a fully integrated solution developed around the Tenzing 7 delivery catheter.
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By GlobalDataWithout the need for a guidewire, the catheter provides predictable access and better navigation to occluded distal vessels.
Furthermore, the advanced design of the system eradicates the ledge effect which is frequently observed in catheters with a large bore.
The FreeClimb 70 Reperfusion System forms part of the company’s family of endovascular interventional devices being developed to improve stroke treatment.
At present, the company is engaged in the enrolment of patients for the SUMMIT MAX clinical study.
The study is designed to support regulatory submissions for the next-generation Monopoint Platform, which includes a super-bore HiPoint 88 catheter that is delivered to the target vessel using Tenzing 8 for thrombectomy procedures.
