The SAFE MANTA IDE clinical trial to evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device

Teleflex Incorporated announced the publication of the “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device.” The SAFE MANTA IDE Clinical Trial, the largest U.S. prospective multi-center study of a purpose-designed large bore femoral arterial access site closure device to date, demonstrated the safety and effectiveness of the MANTA Device. Results were published in Circulation: Cardiovascular Interventions.

The study demonstrated that, in a selected population, the MANTA Device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve (TAVR) replacement, percutaneous endovascular abdominal aortic aneurysm (EVAR) repair, and thoracic endovascular aortic aneurysm (TEVAR) repair devices. The study authors noted that open surgical closure as well as adapted small-bore suture-based pre-closure devices have significant limitations.

The MANTA Device is innovatively designed to potentially reduce bleeding complications and offset other procedural costs.The study demonstrated that the median time from deployment to hemostasis was 24 seconds (65 second mean time). Technical success was achieved in 97.7% of patients, and a single device was deployed in 99.6% of cases. The IDE-defined major complications, the primary safety end point for the study, occurred in 5.3% of patients and Valve Academic Research Consortium -2 (VARC-2) major vascular complications occurred in 4.2% of cases. This VARC-2 rate is lower than published rates for suture-mediated closure.

See- Wood D, et al. "Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device: The SAFE MANTA Study ". Circulation: Cardiovascular Interventions. 2019 July. Vol 12, Issue 7.