MALVERN, Pennsylvania, January 8, 2016 /PRNewswire/ --
Essential Medical, Inc., a privately held medical device company addressing the rapidly emerging large bore vascular closure market, announced today that it is in the final stages of a 50 patient 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.
45 patients have been successfully enrolled in the study to date. Only 5 patients remain to finalize enrollment, with two centers having completed their allocation of patients. A third center is finalizing its enrollments throughout the month of January and submission of all data for approval will occur shortly thereafter. Preliminary clinical results are very positive with a MANTA device deployment-to-hemostasis time of less than 2 minutes. This easy to use and rapid closure technique translates into a significant 20-30 minute or greater savings in total procedure time compared to the current standard of care. Encouragingly, only two patients required adjunctive endovascular ballooning, which is much more common in other closure methods. MANTA has now been implanted in over 60 patients including previous feasibility studies.
MANTA is a novel vascular closure device designed to close punctures ranging from 10F to 24F 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, however their growth is limited by the lack of a safe and reliable large-bore percutaneous closure device. 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.
The leading enrollers in the study were Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands and Azeem Latib, MD, of San Raffaele Scientific Institute and Columbus Hospital, Milan, Italy. Dr. Van Mieghem 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. Latib, MD, said: "the MANTA device simplifies large-bore arterial access closure. The device is easy to use, has a short learning curve, is not operator-dependent and results in immediate hemostasis."
Dr. Gary Roubin, MD, PhD, Essential Medical's Chief Medical Officer, commented on this most recent experience; "we've been impressed with the usability and performance of MANTA in this important study and look forward to starting our FDA IDE study in the very near future."
In other recent news, the Company has now enrolled 42 patients to date in a 50 patient post-market-follow-up study (PMFU) in Germany utilizing its X-Seal™ small-bore closure device. Preliminary results show Time-To-Hemostasis less than one minute with no complications, indicating that X-Seal performs on par or better than existing small-bore VCD's. Tobias Graf, MD, Medical Director, University Heart Clinic in Rostock, Germany, commented "the tension gage within the device is really innovative [and] minimizes risk of device misuse". X-Seal is CE Marked and commercialization is expected through a strategic partner.
About Essential Medical
Essential Medical, Inc., is a privately held company focused on transforming the large bore vascular closure market by delivering products that meet the unmet need for closure without complications. The company was founded in 2010 by Greg Walters, a senior product development executive with 20 years' experience creating innovative cardiovascular products, and Dr. Gary Roubin, MD, PhD, a coronary and carotid stenting pioneer.
SOURCE Essential Medical, Inc.