Results Presented From Pivotal Trial of Essential Medical's Manta Vascular Closure Device
June 25, 2018—Essential Medical, Inc. announced the results from the pivotal SAFE MANTA investigational device exemption (IDE) clinical trial, which is evaluating the company's Manta dedicated large-bore vascular closure device. The study's Coprincipal Investigator David Wood, MD, presented the results at the Transcatheter Valve Therapies (TVT) conference held June 21–23, 2018 in Chicago, Illinois.
The prospective, single-arm SAFE MANTA trial was conducted at 20 sites with 42 operators. The study enrolled 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 Valve Academic Research Consortium-2 (VARC-2) major vascular complications were tracked as a secondary endpoint.
According to the company, 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 days and 60 days. Within the PAC cohort, transcatheter aortic valve replacement was performed in 210 (79.8%) patients, and percutaneous endovascular aneurysm repair or thoracic endovascular aneurysm repair was performed in 53 (20.2%) patients. The 14-F MANTA device was used in 42 patients (16%) and the 18-F device was used in 221 patients (84%).
VARC-2 major vascular complications occurred in 11 patients (4.2%), where four patients received a covered stent (1.5%), three patients had access site bleeding (1.1%), two underwent surgical repair (0.8%), and two underwent balloon inflation (0.8%).
The mean time to hemostasis was 65 ± 157 seconds, and median time to hemostasis was 24 seconds. Hemostasis was achieved in < 1 minute in 86% of the PAC, and in < 5 minutes in 94% of the PAC. Additionally, the technical success rate of the Manta device was 97.7% in the PAC.
Dr. Wood commented, “Data from the IDE study is exciting, particularly the rapid time to hemostasis, and compares favorably to current published outcomes. 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, the study's Coprincipal Investigator, stated, “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 device is designed for large-bore femoral artery closure after percutaneous transcatheter interventions. It features simple deployment of its resorbable collagen material and is designed to achieve fast, reliable closure with rapid hemostasis in access sites ranging from 12 to 25 F.
The Manta vascular closure device has received CE Mark approval and is commercially available in 14 countries in central and northern Europe with continued expansion through the rest of Europe ongoing. It is currently an investigational device in the United States and Canada, the company noted.