Essential Medical has successfully commenced EU clinical studies using its Manta large bore vascular closure device, a vascular closure device designed to seal both 14F and 18F large bore femoral punctures.
Initial patients in the study were enrolled in Rotterdam, the Netherlands, and Milan, Italy, where Manta 18F devices were successfully deployed achieving immediate haemostasis following transcatheter aortic valve replacement with “excellent clinical, angiographic and haemodynamic (Duplex Ultrasound) results,” according to a company press release. The Manta devices were deployed in less than one minute, without pain or discomfort for the patients. None of the patients experienced any complications associated with the device.
Manta closes femoral arterial punctures made during cardiac catheterisation procedures such as transcatheter aortic valve replacement, endovascular treatment of abdominal aortic aneurysms, ventricular assist, and balloon aortic valvuloplasty.
Essential Medical says that these procedures are the fastest growing segment of the cardiovascular market but the growth is limited by the lack of a safe and reliable large-bore percutaneous closure device. Manta was designed to address the complexities of closing large holes in high-pressure vessels utilising novel closure technology. Manta’s deployment closes large punctures in less than 60 seconds, providing immediate haemostasis in order to reduce complications associated with large bore closure. The potential worldwide market for large bore vascular closure device exceeds US$650m.
Cases were conducted by Nicholas Van Mieghem, medical director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, who commented that Manta “is a revolutionary device that will transform how we close cases,” and Antonio Colombo, director of the Invasive Cardiology Department at San Raffaele Scientific Institute and Columbus Hospital, Milan, who commented that Manta “is a nice step [toward] making large bore closure a simple and reliable procedure.”
Closure of large bore femoral access sites has been associated with significant morbidity including long time to achieve haemostasis, extended operating room time, need for a vascular surgeon in the catheterisation lab, delayed ambulation, higher rate of complications and higher total cost of care. Gary Roubin, Essential Medical chief medical officer, said, “The deployment of the devices was flawless, and both clinicians found the Manta to be intuitive, easy-to-use and efficacious. Including our first-in-man studies, we have now enrolled 19 patients to date with rapid haemostasis and no major complications. We look forward to enrolling other centres in Hamburg and Vancouver shortly.”
The company has also now enrolled 23 patients to date in a post-market-follow-up study (PMFU) in Germany utilising its X-Seal small-bore closure device. This study is a 50-patient PMFU study as a requirement for X-Seal CE mark approval. Commercialisation of X-Seal is expected through a strategic partner once the PMFU study is completed.