EXTON, Pennsylvania, June 25, 2018 /PRNewswire/ --
Essential Medical, Inc., a private medical device company focused on innovative solutions for large bore vascular closure, today announced the results from the SAFE MANTA IDE clinical trial, the first pivotal trial for a dedicated large bore closure device. Dr. David Wood, Co-Principal Investigator and founding member of the Centre of Heart Valve Innovation in Vancouver, Canada, presented the results in the Late-Breaking Clinical Science Forum in the Main Arena on June 22nd 2018 at the Transcatheter Valve Therapies (TVT) conference in Chicago.
The SAFE MANTA trial, a prospective, single arm study, utilized 20 sites with 42 operators, and had a total enrollment of 341 patients, with 263 patients in the Primary Analysis Cohort (PAC) and 78 roll-in patients. The primary safety endpoint was incidence of IDE Protocol Major Complications at 30 Days, and the primary effectiveness endpoint was Time to Hemostasis. The more academically relevant Major Valve Academic Research Consortium-2 (VARC-2) Major Vascular Complications were tracked as a secondary endpoint.
The study required rigorous use of imaging at the access site, with angiography at access and closure, as well as duplex ultrasound within 48 hours of the procedure and at 30-day follow-up. Follow-up was at 30 and 60 Days. Within the PAC cohort, TAVI was performed in 210 (79.8%), and PEVAR or TEVAR was performed in 53 (20.2%) cases. The 14F MANTA device was used in 42 cases (16%) and the 18F device was used in 221 cases (84%).
VARC-2 Major Vascular Complications occurred in 11 patients (4.2%), where 4 patients received a covered stent (1.5%), 3 patients had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). Chief Medical Officer at Essential Medical, Dr. Gary Roubin, commented "The results from this study validate our expectations for the promise of MANTA technology, of particular note is the extremely low occurrence of bleeding, which directly relates to the potential for improved clinical and cost outcomes with both TAVR and EVAR."
The mean Time to Hemostasis was 65±157 seconds, and median Time to Hemostasis was 24 seconds. Hemostasis was achieved in less than 1 minute in 86% of the PAC, and in less than 5 minutes in 94% of the PAC. Additionally, the Technical Success rate of the MANTA device was 97.7% in the PAC.
"Data from the IDE study is exciting, particularly the rapid time to hemostasis, and compares favorably to current published outcomes," stated Dr. Wood, "The ease of use associated with the MANTA device and the promising data collected through this trial indicates that MANTA could be the answer to the complex issue of large bore vascular closure. We demonstrated this ease of use during our live case shown in Thursday's session at TVT."
Zvonimir Krajcer MD, co-PI and Director of Peripheral Vascular Diseases at Texas Heart Institute in Houston, TX, which was the highest single enrolling investigational site with 54 patients, reports, "The combination of clinical effectiveness and ease of use provided our lab with an elegant solution to a complex and costly clinical problem during this study."
Essential Medical's MANTA™ Vascular Closure Device is the only device specifically designed for large bore femoral artery closure following percutaneous transcatheter interventions that is currently commercially available outside the U.S. With simple deployment of its resorbable collagen material, a single MANTA device is designed to achieve fast, reliable closure with rapid hemostasis in access sites ranging from 12F to 25F.
Percutaneous cardiac and peripheral catheterization procedures that use a large-bore device, such as transcatheter aortic valve implantation (TAVI), endovascular aneurysm repair (EVAR), ventricular assist device (VAD), and balloon aortic valvuloplasty (BAV), are the fastest growing segment of the cardiovascular market and are driving the potential worldwide market for large bore vascular closure devices to exceed $600 million within 5 years.
Currently investigational in the US and Canada, MANTA is CE marked and available for sale in 14 countries throughout Central and Northern Europe with continued expansion through the rest of Europe ongoing.
About Essential Medical
Essential Medical is a privately held medical device company dedicated to improving patient outcomes with a large bore closure device that achieves fast, reliable closure with rapid hemostasis for cardiovascular procedures requiring percutaneous transcatheter interventions. By fulfilling the unmet need for simple yet effective large bore closure, Essential Medical is mastering closure to support and enable growth of the fastest growing interventional segments within the cardiology market.
SOURCE Essential Medical, Inc.