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Route 92 Medical Gains EU and MDSAP Certification for its Neurovascular Stroke-Intervention-Focused Product Portfolio

By: via GlobeNewswire

SAN MATEO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the achievement of European Union approval (CE mark) under the EU Medical Device Regulation (MDR) 2017/745 for its innovative line of neurovascular intervention products. The company also announced 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,” said Tony Chou, M.D., Route 92 Medical’s founder and Chief Executive Officer. “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., MSc, 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."

For more information about Route 92 Medical, visit www.r92m.com.

About Route 92 Medical, Inc.

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn.


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Gwen Gordon
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