MALVERN, Pennsylvania, February 1, 2016 /PRNewswire/ -- Essential Medical, Inc., a privately held medical device company addressing the rapidly growing large bore vascular closure market, announced today that it has completed enrollment of its European CE Mark clinical study of MANTA, the company's Large Bore Vascular Closure Device. The potential worldwide market for large bore vascular closure devices exceeds $600 million.
Preliminary results from the single arm, 50 patient study show conclusively that MANTA successfully achieves immediate hemostasis in the femoral arterial access site in patients undergoing percutaneous large bore procedures using a 14F to 24F sheath. With immediate hemostasis, 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 0 minor (0%) and 1 major (2%) device related vascular VARC-2 complications.
Lead Investigator Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands commented: "The MANTA vascular closure device revolutionizes any catheter based transfemoral procedure that requires large-bore arterial access. Access management becomes faster, safer, and reproducible in the hands of many more operators."
Azeem Latib, MD, San Raffaele Scientific Institute and Columbus Hospital, Milan, Italy finished out 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 2 to 3 cases. And the hemostasis is immediate. No oozing, just perfect. Compared to what is currently offered, there is no comparison."
Dr. Jan van der Heyden, MD, PhD, St. Antonius Ziekenhuis, Niewegein, Netherlands commented: "MANTA should become a mantra when performing TAVI. The Manta is very intuitive to use and provides instant hemostasis. It's a great asset in the lab and will make TAVR cases even more successful going forward."
Dr. Gary Roubin, MD, PhD, Essential Medical's Chief Medical Officer, commented; "The excellent 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 10 Fr to 24 Fr at femoral arterial access sites after cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), endovascular treatment of abdominal aortic aneurysms (AAA), ventricular assist (VAD), and balloon aortic valvuloplasty (BAV). 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 hemostasis, extended procedure time, need for a vascular surgeon in the catheterization 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 utilizing novel closure technology. MANTA's fail-safe deployment provides immediate hemostasis 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 also in the process of submitting an Investigational Device Exemption (IDE) application to the US FDA for a US pivotal study of MANTA.
The following sites participated in this study:
- San Raffaele Scientific Institute and Columbus Hospital, Milan, Italy
- Erasmus Medical Center, Rotterdam, the Netherlands
- St. Antonius Ziekenhuis, Nieuwegein, the Netherlands