Essential Medical has received CE mark approval for its new vascular closure device, X-Seal. X-Seal closes femoral arterial punctures made during cardiac catheterisation procedures such as angiograms, angioplasty, and stenting. X-Seal is designed to provide cath lab professionals with improved closure and haemostasis. The potential worldwide market for vascular closure products is approximately $1bn.
In addition to X-Seal, Essential Medical is developing MANTA, a large bore device for sealing larger femoral arterial punctures made during transcatheter aortic valve replacement, balloon aortic valvuloplasty, and the endovascular treatment of abdominal aortic aneurysms. This large bore device utilises sealing components similar to X-Seal, and can be easily deployed within 60 seconds.
First in man studies are starting soon and a larger EU study is expected to begin in 2015. “We expect our large bore device will provide a closure solution that will improve patient outcomes and reduce the overall cost of the respective procedures with an easy to use product,” says Greg Walters, chief executive officer.