The MANTA vascular closure device (Essential Medical, Inc., Exton, Pennsylvania) had a successful US investigational device exemption (IDE) study with low major and minor complication rates and a short average time to hemostasis, according to results presented recently at the Transcatheter Valve Therapies (TVT) conference in Chicago.
The study is formally known as the Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device: The SAFE MANTA Study. The study’s primary analysis cohort consisted of 263 patients in 20 North American centers who were candidates for elective transcatheter aortic valve replacement (TAVR) (79.8%), or endovascular aneurysm repair or percutaneous endovascular aneurysm repair (20.2%). To be included in this open-label, single arm study patients had to have minimum vessel size as determined by CT angiography of 6 mm for the 18F MANTA (84%) and 5 mm for the 14F MANTA (16%).
MANTA is a vascular closure device intended for use following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large-bore (10-18F) interventional devices. MANTA’s function is to percutaneously close the puncture of the artery wall through which the catheters were inserted for the procedure.
The study’s primary safety endpoint was major complications within 30 days of procedure. There were 14 patients (5.3%) who experienced defined major complications: 6 cases of bleeding (2.3%), 4 cases of covered stent (1.5%), 2 cases of surgical repair (0.8%), and 2 cases of balloon inflation (0.8%), according to data presented at TVT by study co-principal investigator David Wood, MD, of the University of British Columbia in Vancouver.
The primary effectiveness endpoint was time to hemostasis from time of MANTA sheath withdrawal. The mean time to hemostasis was 65±158 seconds with median of 24 seconds. Most patients, 227 (86.3%), achieved hemostasis in <1 minute.
A secondary safety endpoint was major vascular complications as defined by the Valve Academic Research Consortium (VARC)-2. There were 11 patients (4.2%) with VARC-2 major vascular complications: 3 cases of bleeding (1.1%), 4 cases of covered stent (1.5%), 2 cases of surgical repair (0.8%) and 2 cases of balloon inflation (0.8%).
Another secondary safety endpoint was minor complications. There were 9 minor complications (3.4%): 8 pseudoaneurysms and 1 transient access site nerve injury.
“Data from the IDE study is exciting, particularly the rapid time to hemostasis, and compares favorably to current published outcomes,” Wood said in an Essential Medical news release. “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.”
The secondary effectiveness endpoint was technical success, which was 97.7%.
"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," co-principal investigator Zvonimir Krajcer, MD, of the Baylor College of Medicine in Houston, Texas, said in Essential Medical’s news release.
MANTA is investigational in the US and Canada. The device is CE-marked and available for sale in 14 countries throughout Central and Northern Europe with continued expansion throughout the rest of Europe ongoing, according to the company.
The study is sponsored by Essential Medical, Inc.
Essential Medical, Inc.