Route 92’s FreeClimb 70 Reperfusion System Cleared by FDA

April 24, 2023—Route 92 Medical, Inc., a privately held medical technology company focused on neurovascular intervention, announced receipt of FDA 510(k) clearance for the FreeClimb 70 reperfusion system that includes a FreeClimb 70 aspiration catheter with a Tenzing 7 delivery catheter.

According to the company, the FreeClimb 70 reperfusion system enables rapid and safe removal of clots in patients experiencing an acute ischemic stroke. The system is designed to work harmoniously for superior deliverability and high procedural efficiency with a refined bi-axial approach for restoring blood flow to the brain during endovascular thrombectomy procedures. The Tenzing 7 delivery catheter offers superior navigation and predictable access to occluded distal vessels without the need for a guidewire. The system is designed to eliminate the ledge effect that is found in large-bore catheters, noted the company.

James Caldwell, MD, an early user of the system at Auckland City Hospital in Auckland, New Zealand, commented in the company press release, “In our initial experience with FreeClimb 70 and Tenzing 7, the system easily delivered to the target occlusion allowing rapid, effective, and safe reperfusion. Tenzing-based delivery can reduce procedure time and may reduce complications. This comprehensive solution will help clinicians overcome challenging neurovascular anatomy with greater ease and efficiency, providing better care for their patients.”

The FreeClimb 70 reperfusion system is part of Route 92 Medical’s catalog of endovascular interventional devices that are being designed to refine stroke treatment.

The company advised that it is currently recruiting patients for the SUMMIT MAX clinical trial that will support regulatory submissions for the next-generation Monopoint platform, which is a super-bore HiPoint 88 catheter delivered with Tenzing 8 for thrombectomy procedures. More information about the trial is available on the company’s website.