Route 92 Medical has announced its first commercial cases in Canada following receipt of a Health Canada medical device licence for the company’s portfolio of advanced neurovascular technologies.
As per a Route 92 press release, the company’s HiPoint 88 system featuring the unique Monopoint approach was used in the first commercial Canadian procedures by Vitor Mendes Pereira (St Michael’s Hospital, Toronto, Canada).
“In the cases we performed, Route 92’s platform enabled smooth, atraumatic navigation through complex neurovascular anatomy and successful delivery of implants to the target vessels,” said Pereira. “The ability to advance the system without guidewires from a single point of control simplifies access and supports procedural efficiency. Moreover, the telescoping design coupled with the Tenzing delivery catheter allows for atraumatic navigation, particularly in challenging anatomy.”
According to Route 92, Canada’s established neurovascular treatment infrastructure and reimbursement pathways provide a “significant commercial opportunity” for the company’s differentiated portfolio.
“Receiving Health Canada authorisation marks an important milestone in Route 92’s international expansion, and enables us to bring our differentiated neurovascular intervention platform to physicians and patients across Canada,” said Tony Chou, founder and chief executive officer (CEO) of Route 92. “We are particularly encouraged by the successful first clinical experience at St Michael’s Hospital and look forward to supporting Canadian physicians treating patients with acute ischaemic stroke and other neurovascular conditions.”
Route 92 says this Canadian regulatory authorisation covers the company’s product portfolio, including the HiPoint 70/Tenzing 7 reperfusion system, HiPoint 88/Tenzing 8 reperfusion system, FreeClimb 54/Tenzing 5 reperfusion system, FreeClimb 70/Tenzing 7 reperfusion system, and Base Camp sheath system.
