Route 92’s Neurovascular Intervention Devices Gain CE Mark Approval Under EU MDR

December 3, 2024—Route 92 Medical, Inc. recently announced that its line of neurovascular intervention products has received CE Mark approval under the European Union (EU) Medical Device Regulation (MDR) 2017/745. The company also announced clearance under the Medical Device Single Audit Program, or MDSAP, which gives broad access to international markets.

The press release advised that the regulatory authorization covers the majority of Route 92 Medical’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,” commented Francesco Massari, MD, in the company’s press release. “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.”

The company noted Dr. Massari is an Associate Professor of Radiology at Boston University Medical School and a neurointerventionalist at Boston Medical Center in Boston, Massachusetts.

Route 92 Medical’s founder and Chief Executive Officer Tony Chou, MD, stated in the press release, “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. 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.”

Dr. Chou added, “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 United States, we can now work toward commercializing our products in Europe.”