Essential Medical, Inc., says it has successfully completed First in Man studies for its MANTA Large Bore Vascular Closure device, a revolutionary vascular closure device designed to seal 18F large bore femoral punctures.
The inexorable shift towards more catheter-based approaches to the heart still leaves interventional cardiologists with the problem that large bore femoral access has been associated with significant morbidity. This includes bleeding complications, the need for transfusions, increased hospital costs, patient discomfort and disability.
Essential Medicine is hoping its MANTA device, while not yet at market, will provide the answer, and has now seen it deployed in five patients.
MANTA closes femoral arterial punctures made during cardiac catheterization procedures, using sealing components similar to the Company’s other closure device, X-Seal, itself CE marked in recent months. The company claims it will seal openings up to 18F, which is 6mm, meaning it would have utility that is expected to extend to transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA).
The initial series of five saw 18F MANTA devices were safely and effectively used to achieving immediate or rapid hemostasis at the large bore puncture site with excellent clinical, angiographic and hemodynamic (Duplex) success in all patients. Patients were discharged the following day with no evidence of hematoma in any of them. Usefully, the MANTA devices were deployed in less than one minute in each patient.
Co-founder of Essential Medicine, interventional cardiologist Dr. Gary Roubin, MD, PhD, performed the first two cases and commented, “In interventional cardiology it’s critical to define the problem that the patient is facing, solve the problem and use the best clinical science available to confirm beneficial outcomes. We’re doing that with MANTA and it promises to be a truly transformative technology for providing percutaneous access for large bore therapeutic devices.”
Dr. Lawrence Garcia, Chief of Interventional Cardiology, St. Elizabeth’s Medical Center in Boston and internationally recognized as a thought leader in peripheral vascular interventions who also participated in the study stated, “This device fills a critical unmet need for endovascular procedures in being able to quickly and reliably close large bore catheter channels. This ability, done simply and safely is a major step to full percutaneous procedures in both the Cardiac and Peripheral markets.”
“Our team is thrilled to bring forward a device technology that can manage challenging 14F and 18F closures,” commented Greg Walters, Essential Medicine’s founder and CEO. “We look forward to initiating a CE-marking study in early 2015.”
Source: Essential Medical, Inc., PR Newswire