Route 92 Medical has announced new results from a multicentre clinical study evaluating the efficacy, safety and efficiency of the Tenzing 7 delivery catheter as a means for delivering therapeutic devices for mechanical thrombectomy in acute ischaemic stroke.
The results—now published in Stroke: Vascular and Interventional Neurology—demonstrate a 95.9% success rate in delivering large-bore reperfusion catheters to the clot face without needing a stent retriever to anchor.
In addition, 94.9% of cases achieved successful recanalisation, and 54.2% of cases achieved successful first-pass reperfusion with a 0.068-inch (inner diameter) aspiration catheter. According to Route 92, this compares favourably with the best stent-retriever data, including with the use of “cumbersome” balloon guides.
Patients also experienced a significant median National Institutes of Health stroke scale (NIHSS) improvement of 10 at hospital discharge, while 41% of patients achieved a good 90-day functional outcome in the study.
“Early clinical and in-vitro experiences have always shown the potential of the Tenzing 7 delivery catheter,” said Dan Tonetti (Cooper University Health Care, Camden, USA), one of the lead contributors to the study. “These multicentre results support its position as a game-changer in the field of neurointervention.”
“These findings underline our unwavering commitment to elevating patient outcomes through the development of best-in-class neurovascular intervention tools,” added Joey D English, chief medical officer at Route 92. “The results illustrate the power of the Tenzing technology to elevate the clinician experience, improve patient outcomes, and set a new benchmark of thrombectomy for the industry as part of a complete stroke treatment solution, such as our recently launched FreeClimb 70 reperfusion system powered by Tenzing 7. Large-bore aspiration catheters reaching the target consistently, without crossing the embolus, have the potential to create less downstream effects. Tenzing is a major advance.”