Route 92 Medical Announces Impressive Clinical Results for its Tenzing® Technology.

2023-11-14

临床结果临床研究

Multicenter clinical study showcases how Tenzing® technology is improving neurovascular intervention outcomes

SAN MATEO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced compelling results from a multicenter clinical study1 on the Tenzing® 7 Delivery Catheter published in Stroke: Vascular and Interventional Neurology. The research, conducted across multiple institutions, aimed to evaluate the efficacy, safety, and efficiency of the Tenzing 7 Delivery Catheter in delivering therapeutic devices for mechanical thrombectomy in acute ischemic strokes.

Key findings from the study include:

A 95.9% success rate in delivering large-bore reperfusion catheters to the clot face powered by Tenzing 7 delivery catheter without needing a stent-retriever to anchor.

94.9% of cases achieved successful recanalization.

54.2% of cases achieved successful first-pass reperfusion with a 07-sized aspiration catheter. This compares favorably with the best stent retriever data including with use of cumbersome balloon guides.2

Patients experienced a significant median NIHSS improvement of 10 at hospital discharge.

41.0% of patients achieved a good 90-day functional outcome.

"Early clinical and in vitro experiences have always shown the potential of the Tenzing 7 delivery catheter. These multicenter results support its position as a game-changer in the field of neurointervention," said Dan Tonetti, MD, Director, Acute Stroke and Neurointerventional Suite at Cooper University Health Care, and one of the lead contributors to the study.

"These findings underline our unwavering commitment to elevating patient outcomes through the development of best-in-class neurovascular intervention tools,” said Joey D. English, MD, PhD, Chief Medical Officer at Route 92 Medical. “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.”

For more information about Route 92 Medical and the Tenzing 7 Delivery Catheter, visit www.route92medical.com.

About Route 92 Medical, Inc.

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.route92medical.com or follow the company on LinkedIn.

1 Tonetti et al. Novel Tenzing 7 Delivery Catheter for Thrombectomy in Acute Stroke: A Clinical Multicenter Experience. Stroke Vasc Interv Neurol. 2023 Available: https://www-ahajournals-org.libproxy1.nus.edu.sg/doi/10.1161/SVIN.123.000940

2 Zaidat et al. First Pass Effect. A New Measure for Stroke Thrombectomy Devices. Stroke 2018; 49: 660-666. Available: https://www-ahajournals-org.libproxy1.nus.edu.sg/doi/10.1161/STROKEAHA.117.020315?url_ver=Z39.882003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

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