InSeal Medical Receives CE Mark for Vascular Closure Device
InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood vessels. The figures below show InSeal’s InClosure VCD, before (left) and after (right) biodegradation.
According to PRNewswire, the need for such a device is, at least partially, driven by the increased prevalence of transcatheter heart valve procedures, which involve the delivery of relatively large medical device through a patient’s blood vessels. While superior in some respects to open-heart surgical alternatives, these transcatheter procedures still require making a large puncture in a blood vessel in order to introduce the medical device. The InClosure device is aimed at addressing these punctures.
InSeal Medical, Ltd. is a subsidiary of E-Pacing, Inc., and is based in Caesarea, Israel.
Essential Medical, Inc. Successfully Completes First in Man Studies for MANTA Large Bore Vascular Closure Device
Essential Medical, Inc., a privately held medical device company aiming to create and commercialize new vascular closure devices for femoral punctures after cardiac catheterization procedures, announced that it has successfully completed First in Man studies for its MANTA Large Bore Vascular Closure device, a device designed to seal 18F large bore femoral punctures.
According to the press release, the MANTA devices were deployed in less than one minute in each of five patients, achieving hemostasis at the large bore puncture site with exceptional clinical, angiographic and hemodynamic success in all patients. The press release also indicated that none of the patients showed evidence of hematoma, and all patients were discharged the next day.
Essential Medical stated that Dr. Gary Roubin, MD, PhD, a leading interventional cardiologist, performed the first two cases. Dr. Roubin remarked:
“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.”
According to Essential Medical, MANTA seals femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA), employing sealing components similar to the Company’s other closure device, X-Seal, which received CE mark approval last month, and is said to be indicated for smaller punctures for angiography, angioplasty, and stenting.
Essential Medical indicates that large bore femoral access has been associated with bleeding complications, the need for transfusions, increased hospital costs, and patient discomfort and disability. Dr. Lawrence Garcia, Chief of International Cardiology at St. Elizabeth’s Medical Center in Boston, also participated in the study and stated that the device satisfies a “critical unmet need for endovascular procedures in being able to quickly and reliably close large bore catheter channels.”
Greg Walters, founder and CEO, states in the announcement that Essential Medical seeks to commence a CE-marketing study of the MANTA device in early 2015.
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