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.”
