Essential Medical has successfully completed First in Man studies for its Manta large bore vascular closure device, a vascular closure device designed to seal 18F large bore femoral punctures.
The series saw 18F Manta devices safely and effectively deployed in five patients, achieving immediate or rapid haemostasis at the large bore puncture site with excellent clinical, angiographic and haemodynamic (duplex) success in all patients. Patients were discharged the following day. There was no evidence of haematoma in any patient. The Manta devices were deployed in less than one minute in each patient.
Manta closes femoral arterial punctures made during cardiac catheterisation procedures such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA). Manta can be deployed in less than 60 seconds and utilises sealing components. The potential worldwide market for vascular closure products is approximately US$1bn.
Gary Roubin performed the first two cases and comments: “In interventional cardiology it is 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 are doing that with Manta and it promises to be a truly transformative technology for providing percutaneous access for large bore therapeutic devices.”
Lawrence Garcia, chief of interventional cardiology, St Elizabeth’s Medical Center, Boston, who also participated in the study states: “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.”