Enrollment Completed in EU Clinical Studies for Essential Medical's Manta Large-Bore Vascular Closure Device

February 1, 2016—Essential Medical, Inc. announced that it has completed enrollment of its European CE Mark clinical study of Manta, the company's large-bore vascular closure device. The study enrolled patients at San Raffaele Scientific Institute and Columbus Hospital in Milan, Italy; Erasmus Medical Center in Rotterdam, the Netherlands; and St. Antonius Ziekenhuis in Nieuwegein, the Netherlands.

Essential Medical was founded in 2010 by Greg Walters and Gary Roubin, MD, a coronary and carotid stenting pioneer. Dr. Roubin, the company’s Chief Medical Officer, commented, “The excellent operator acceptance and outcomes allowed Essential Medical to complete our European Union Manta Study ahead of schedule.”

The Manta device is designed to close punctures ranging from 10 to 24 F at femoral arterial access sites after cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), endovascular treatment of abdominal aortic aneurysms, ventricular assist, and balloon aortic valvuloplasty. 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 to reduce complications associated with large-bore closure.

Essential Medical’s submission for CE Mark approval is currently being prepared, with expected commercial approval by midsummer. Essential Medical is also in the process of submitting an investigational device exemption application to the US Food and Drug Administration for a United States pivotal study of Manta.

According to the company, preliminary results from the single-arm, 50-patient study demonstrated that Manta achieved immediate hemostasis in the femoral arterial access site in patients undergoing percutaneous large-bore procedures using a 14- to 24-F sheath. With immediate hemostasis and a device deployment time of 1 to 2 minutes, operators are seeing 20 to 30 minutes or greater savings in total procedure time when compared to suture-mediated closure devices. There were zero minor (0%) and one major (2%) device-related vascular VARC-2 complications.

In the company’s press release, lead investigator Nicolas Van Mieghem, MD, 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.” Dr. Van Mieghem is Medical Director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center.

Azeem Latib, MD, of the San Raffaele Scientific Institute and Columbus Hospital, finished the study on January 29, with his twelfth Manta case. He stated in the announcement, “Manta is very easy to use for everyone. I can teach you how to use Manta effectively within two to three cases. And the hemostasis is immediate. No oozing, just perfect. Compared to what is currently offered, there is no comparison.”

Jan van der Heyden, MD, of St. Antonius Ziekenhuis, added, “Manta should become a mantra when performing TAVR. 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.”