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Route 92 Medical picks up CE mark for stroke portfolio

November 20, 2024 By Sean Whooley

Route 92 Medical stroke treatment FreeClimb 70 Reperfusion System
The FreeClimb 70 Reperfusion System. [Image courtesy of Route 92 Medical]
Route 92 Medical announced today that it received CE mark for its line of neurovascular intervention products for treating stroke.

The company also picked up clearance under the MDSAP program, giving broad access to international markets. 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

Route 92 develops a suite of reperfusion and access systems leveraging the patented Tenzing delivery catheter. The products aim to improve the efficiency of endovascular thrombectomy procedures. The company designed its technology to enable the quick restoration of blood flow to the brain following acute ischemic stroke.

Route 92 Medical’s products treat acute ischemic stroke. The Tenzing catheters offer new, improved ways to atraumatically advance through the challenging-to-navigate neurovascular. The technology allows clinicians to reach and remove clots without the need for guidewires and crossing the clot.

“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 Dr. Tony Chou, Route 92 Medical founder and CEO. “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.”

Filed Under: Applications, Catheters, CE Mark, Neurology, Regulatory, Technologies & Devices Tagged With: Route 92 Medical

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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