Safety and Efficacy Data Published for Teleflex's Manta Closure Device
July 12, 2019—Findings from SAFE MANTA, the pivotal clinical study to evaluate the safety and effectiveness of the Manta percutaneous vascular closure device (Teleflex), were published by David A. Wood, MD, et al in Circulation: Cardiovascular Interventions.
The Manta device, which features collagen-based technology, is designed to close large-bore arteriotomies created by devices with an outer diameter ranging from 12 to 25 F. The investigators stated that this study demonstrated the safety and effectiveness of the Manta vascular closure device. In February, Teleflex announced FDA approval of the device for large-bore femoral artery access site closure.
As summarized in Circulation: Cardiovascular Interventions, this prospective, single-arm, multicenter investigation included patients undergoing transcatheter aortic valve replacement (TAVR), percutaneous endovascular abdominal aneurysm repair (EVAR), or thoracic endovascular aneurysm repair (TEVAR) at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were access site–related vascular injury or bleeding complications. The study investigators enrolled a total of 341 patients (78 roll-in and 263 in the primary analysis cohort) in the study between November 2016 and September 2017. For the primary analysis cohort, TAVR was performed in 210 (79.8%) patients and percutaneous EVAR or TEVAR was performed in 53 patients (20.2%).
The 14-F Manta device was used in 42 (16%) patients, and the 18-F Manta device was used in 221 (84%) patients. The mean effective sheath outer diameter was 22 F (7.3 mm). The mean time to hemostasis was 65 ± 157 seconds, with a median time to hemostasis of 24 seconds.
The investigators reported that technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: four (1.5%) received a covered stent, three (1.1%) had access site bleeding, two (0.8%) underwent surgical repair, and two (0.8%) underwent balloon inflation.
In a selected population, this study demonstrated that the Manta percutaneous vascular closure device can safely and effectively close large-bore arteriotomies created by current-generation TAVR and percutaneous EVAR and TEVAR devices, concluded the investigators in Circulation: Cardiovascular Interventions.