Prospective, Multi-Center, Single-Arm Study Demonstrates Effectiveness of Terumo Medical Corporation’s Cross-Seal™ Suture-Mediated Vascular Closure Device (VCD) System
– IDE trial results show primary safety endpoint was achieved –
SOMERSET, NJ, March 20, 2023 – Terumo Medical Corporation (TMC) announced the results of the Investigative Device Exemption (IDE) trial for its Cross-Seal Suture-Mediated VCD System*. It showed, among other things, that the primary safety endpoint — freedom from major complications at the target limb access site within 30 days post-procedure — was achieved.
“We are excited to have successfully completed this study evaluating our novel, suture-based, large-bore closure device, which we believe will significantly and safely simplify femoral arterial closure with the placement of two sutures using a single device,”[1] said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation.
Prakash Krishnan, MD, FACC, FSCAI, Icahn School of Medicine at Mount Sinai, and Mazin Foteh, MD, FACS, FSVS, Texas Vascular Associates, served as principal investigators for the study.
“I was very privileged to have an opportunity to present the data from the Cross-Seal IDE study on behalf of the study investigators,” said Dr. Krishnan, after the Late Breaking Trial session at the VIVA ’22 Congress in Las Vegas. “The study met both safety and performance objectives. Moreover, this novel Suture Mediated Vascular Closure Device System allows us to close arteriotomy of <18 Fr in the majority of the patients in less than 10 seconds.”[2]
Study Results and Criteria
The study was conducted in 19 U.S. hospitals from August 2019 to March 2021 and included 147 patients requiring intravascular treatment through large-bore femoral arterial access. Transcatheter aortic valve replacement was performed in 53.7%, and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 46.3%. Technical success, defined as achievement of hemostasis with the investigational device without the need for any access-site intervention was achieved in 92.3% of subjects, and in 73% of patients hemostasis was achieved in less than 10 seconds. The primary safety endpoint of freedom from major complications at the target limb access site within 30 days post-procedure was also reached.
*Note: Caution – investigational device, limited by federal law to investigational use; not available for sale in the United States.
About Terumo Medical Corporation
Terumo Medical Corporation (TMC) is a subsidiary of Terumo Corporation, founded in 1972 as the United States expansion of our larger Tokyo-based parent. For over 50 years, TMC has continued the Terumo mission of offering the best possible solutions to healthcare providers and the people they serve. TMC provides products and services across four divisions: Terumo Health Outcomes (THO), which provides healthcare systems with solutions designed to reduce care variation, improve quality metrics, minimize cost and maximize revenue; Terumo Interventional Systems (TIS), which offers solutions for entry site management and lesion access; Terumo Medical Products (TMP), which provides devices for injection and infusion therapy; and Terumo Pharmaceutical Solutions (TPS), which develops drug delivery devices.
About Terumo
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for over 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. More information can be found at www.terumo.com.
[1] 008_Section 4 - Clinical Study Results 4-25 Conclusion “The results of the Cross-Seal™ Suture-Mediated Vascular Closure Device System confirm safety and effectiveness of the device…”
[2] 008_Section 4 - Clinical Study Results 4-20 4.5.3 Primary Effectiveness Endpoint “Median (IQR) 0.05 (0.017 - 0.15)”