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.
Contact:
Shuki Porath, CEO,
+972-544-336-486,
Shuki@esvacular.com.
ES Vascular Ltd.
