Route 92 Medical’s Neurovascular Interventions Portfolio Approved in Australia

April 1, 2025—Route 92 Medical, Inc. announced approval from the Australian Therapeutic Goods Administration (TGA) for its neurovascular intervention portfolio, which includes its 0.088-inch super-bore reperfusion systems: the FreeClimb 88 catheter powered by Tenzing technology and the Monopoint-based HiPoint 88 super-bore catheter.

The company introduced its technology at the Australian and New Zealand Society of Neuroradiology annual scientific meeting held March 27-29, 2025, in Perth, Australia.

Specifically, the regulatory authorization includes the following Route 92 Medical products:

• HiPoint 70/Tenzing 7 reperfusion system
• HiPoint 88/Tenzing 8 reperfusion system
• FreeClimb 70/Tenzing 7 reperfusion system
• FreeClimb 88/Tenzing 8 reperfusion system
• Base Camp sheath system

Hal Rice, MBBS, Director of Neurointervention at Gold Coast University Hospital in Southport, Australia, commented on the portfolio in the company’s press release. “We’ve had great success in our initial evaluation of Route 92 Medical’s stroke-treatment portfolio. It offers superb enhanced delivery with the Tenzing system to navigate easily in the most tortuous of neurovasculature to quickly and efficiently reach the site of stroke vessel occlusion.

“The system offers robust capabilities that address a broad range of neurovascular intervention challenges, including efficiently navigating to and effectively aspirating stroke-causing clots to deliver rapid cerebral reperfusion and a high proportion of first-pass effect in cases we have recently treated.”