Essential Medical has completed enrolment of its European CE mark clinical study of Manta, the company’s large bore vascular closure device.
Preliminary results from the single arm, 50 patient study show that Manta successfully achieves immediate haemostasis in the femoral arterial access site in patients undergoing percutaneous large bore procedures using a 14F to 24F sheath. With immediate haemostasis, and a device deployment time of 1-2 minutes, operators are seeing 20-30 minutes or greater savings in total procedure time when compared to suture mediated closure devices. There were zero (0%) minor device-related vascular complications, and one major (2%) device-related vascular complication.
Lead investigator Nicolas Van Mieghem, medical director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands comments, “Access management becomes faster, safer and reproducible in the hands of many more operators.”
Azeem Latib, San Raffaele Scientific Institute and Columbus Hospital, Milan, Italy finished the study on Friday with his 12th Manta case. He states “Manta is very easy to use for everyone. I can teach you how to use Manta effectively within two to three cases. And the haemostasis is immediate. No oozing, just perfect. Compared to what is currently offered, there is no comparison.”
Jan van der Heyden, St. Antonius Ziekenhuis, Niewegein, Netherlands comments, “Manta should become a mantra when performing transcatheter aortic valve implantation (TAVI). The Manta is very intuitive to use and provides instant haemostasis. It’s a great asset in the lab and will make transcatheter aortic valve replacement (TAVR) cases even more successful going forward.”
Gary Roubin, Essential Medical’s chief medical officer, comments, “Operator acceptance and outcomes allowed Essential Medical to complete our EU Manta Study ahead of schedule.”
Manta is a novel vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterisation procedures such as TAVR, endovascular treatment of abdominal aortic aneurysms, ventricular assist, and balloon aortic valvuloplasty. These procedures are the fastest growing segment of the cardiovascular market. Closure of large bore femoral access sites has been associated with significant morbidity including long times to achieve haemostasis, extended procedure time, need for a vascular surgeon in the catheterisation lab, delayed ambulation, higher rate of complications and higher total cost of care. Manta was designed to address the complexities of closing large punctures in high-pressure vessels utilising novel closure technology. Manta’s fail-safe deployment provides immediate haemostasis in order to reduce complications associated with large bore closure.
A CE mark submission is currently being prepared with expected commercial approval in mid-summer. Essential Medical is in the process of submitting an investigational device exemption application to the US Food and Drug Administration for a US pivotal study of Manta.