HAIFA, Israel, April 14 /PRNewswire/ -- ES Vascular Ltd. announced today that it has received a CE Mark approval for its Open Aortic Stapler (OAS) system for mechanical suturing technology of aortic synthetic grafts during open repair of AAA and other aortic reconstructions, enabling commercialization of the device in most European countries. Based on its proprietary stapling technology, the OAS stapler is a unique device that enables one shot stapling of synthetic grafts to aorta in open repair of abdominal and thoracic aneurysmal and occlusive disease, replacing lengthy and cumbersome manual suturing in these major procedures.
"We are very pleased to have received CE Mark for our OAS device and will immediately implement our strategy to make it available in approved countries. Positive clinical data position OAS to be a break-through product for patients and physicians alike," said Shuki Porath, CEO of ES Vascular.
Prof. Ralf Kolvenbach, Chief of Vascular Surgery and Endovascular Therapy at Augusta Hospital in Dusseldorf, Germany and a principal investigator for the OAS clinical trial program, commented, "OAS provides the construction of a geometrically perfect, uniform and standardized anastomosis that will not depend on the skills of the surgeon, is one of the principles lying behind the design of the OAS. This safety and feasibility trial showed that we now have the technology to use aortic stapling in a clinical setting. The aortic stapler can create a uniform staple line between any synthetic vascular prosthesis and the aortic wall. It is a simple, safe, rapid and reliable technique to perform a sutureless, end-to-end anastomosis in patients with aortic aneurysms or occlusive disease."
ES Vascular will be presenting the OAS and other products at the MedtechInsight conference "Investment In Innovation (In3) Europe", Paris, April 29-30.
About OAS System
The OAS system is comprised of applier and implantable staples and also includes specially designed clamp. The OAS device consists of two parts: a barrel shaped head and a handle. The head of the OAS device is pre-loaded with 10 stainless steel (316 LVM) staples that can be fired in one shot from the inside of the aorta to the outside through the synthetic graft. The staples form a pseudo-continuous suturing line, firmly attaching the graft to the aorta. The OAS is available in 16, 18, 20 and 22 mm diameters.
About ES Vascular, Ltd.
ES Vascular Ltd., http://www.esvascular.com, a privately held company, is engaged in the development, licensing and commercialization of its proprietary product line of one-shot, instantaneous anastomotic stapling devices for open, laparoscopic and endovascular abdominal and thoracic aortic surgery and for minimally invasive surgery of SFA. Their use is anticipated to revolutionize vascular surgery resulting in improved clinical outcome, higher patient benefit and decreased costs.
ES Vascular will be presenting the OAS and other products at the MedtechInsight conference "Investment In Innovation (In3) Europe", Paris, April 29-30.
SOURCE ES Vascular Ltd.
