Health Canada Grants Medical Device License to Route 92 Medical’s Neurovascular Tech

Route 92 Medical Inc. announced the first commercial cases in Canada, having recently earned a Health Canada Medical Device License for its portfolio of advanced neurovascular technologies. 

Route 92 Medical’s HiPoint 88 system featuring the unique Monopoint approach was used in the first commercial Canadian procedures by Vitor Mendes Pereira, M.D., at St. Michael’s Hospital in Toronto, a neurovascular center.

“In the cases we performed, Route 92 Medical’s platform enabled smooth, atraumatic navigation through complex neurovascular anatomy and successful delivery of implants to the target vessels,” said Dr. Pereira, a professor of Surgery and Medical Imaging at the University of Toronto and director of Endovascular Research and Innovation at St. Michael’s Hospital. “The ability to advance the system without guidewires from a single point of control simplifies access and supports procedural efficiency. Moreover, the telescoping design coupled with the Tenzing delivery catheter allows for atraumatic navigation, particularly in challenging anatomy.”

More than 100,000 patients suffer from strokes annually in Canada, including acute ischemic strokes, many of whom could benefit from endovascular treatment. The country’s established neurovascular treatment infrastructure and reimbursement pathways provide a significant commercial opportunity for Route 92 Medical’s differentiated portfolio, according to the company.

“Receiving Health Canada authorization marks an important milestone in Route 92 Medical’s international expansion and enables us to bring our differentiated neurovascular intervention platform to physicians and patients across Canada,” Route 92 Medical Founder/CEO Tony Chou, M.D., stated. “We are particularly encouraged by the successful first clinical experience at St. Michael’s Hospital and look forward to supporting Canadian physicians treating patients with acute ischemic stroke and other neurovascular conditions.”

The Canadian regulatory authorization covers the company’s product portfolio, including:

• HiPoint 70/Tenzing 7 Reperfusion System
• HiPoint 88/Tenzing 8 Reperfusion System
• FreeClimb 54/ Tenzing 5 Reperfusion System
• FreeClimb 70/Tenzing 7 Reperfusion System
• Base Camp Sheath System

Route 92 Medical is striving to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and product design. Founded by physicians, the company collaborates with neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success.