CE Mark Granted to Route 92 Medical’s Neurovascular Intervention Portfolio

Route 92 Medical Inc. has garnered CE mark approval under the European Union Medical Device Regulation (MDR) for its neurovascular intervention product line. The company also secured clearance under the MDSAP program, which gives broad access to international markets.

“Securing EU MDR certification for our portfolio of reperfusion systems opens the door to entering the European market, and can lower the regulatory barriers to enter other new markets,” Route 92 Medical Founder/CEO Tony Chou, M.D., said. “Navigating the EU MDR certification process was a significant challenge, requiring compliance with an extensive framework of regulations and guidance documents, as well as extensive communications with our notified body. This approval represents a critical milestone in our progress towards becoming a global player in the neurovascular intervention market. While our focus today is the U.S., we can now work toward commercializing our products in Europe.”

Route 92 Medical’s products are covered by a global portfolio of more than 100 patents. The regulatory authorization covers the majority of the company’s products including:

• 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

“European clinicians welcome the availability of additional, high-quality tools to support neurovascular procedures and treat acute ischemic stroke,” said Francesco Massari, M.D., Ph.D., associate professor of Radiology at Boston University Medical School and NeuroInterventionalist at Boston Medical Center, who trained at the University of Rome Tor Vergata. “Leveraging the power of its Tenzing catheters, Route 92 Medical’s products offer clinicians new and improved ways to atraumatically advance through the challenging-to-navigate neurovasculature to reach and remove clots, without the need for guidewires and crossing the clot, thus facilitating efficient procedures and robust first-pass effect.”

Route 92 Medical strives 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 differentiated solutions that promote clinical success.