Route 92 Medical today announced US Food and Drug Administration 510(k) clearance for the FreeClimb 46 catheter with Tenzing 4—two components that are engineered as an integrated system to provide neurovascular access.
“In neurovascular intervention, access is critical,” said Matthew Alexander (Sutter Medical Center, Sacramento, USA). “Tenzing supports consistent navigation through even the most challenging cases, allowing us to reach the anatomy we need to treat. The FreeClimb 46 with Tenzing 4 expands Route 92’s catheter technologies to smaller and more distal vessels, where the clinical need is large and accurate delivery is critical to achieving the best outcomes for my patients. I look forward to bringing this next level of neurovascular access into my practice.”
FreeClimb 46 and Tenzing 4 are the newest offerings in Route 92’s portfolio of advanced neurovascular catheters. The FreeClimb 46 system joins FreeClimb 54, 70 and 88, and complements the HiPoint 70 and HiPoint 88 systems, which also feature the company’s proprietary Monopoint single-operator system. All Route 92 access and aspiration catheters are powered by custom-sized Tenzing delivery catheters. According to the company, the navigational capabilities of Tenzing enable atraumatic, precise and controlled access through neurovascular anatomy, establishing stable access for the treatment of complex neurovascular diseases.
The FreeClimb 46 catheter system—including Tenzing 4—and all Route 92 catheters and systems are covered by a portfolio of more than 200 issued patents in the US and international jurisdictions, the company also states in today’s press release.
