neoSurgical® Announces CE Mark Approval of the neoClose® Laparoscopic Port Closure Device
18 Oct, 2016, 15:49 BST
NEWTON, Massachusetts, Oct. 18, 2016 /PRNewswire/ -- neoSurgical, Inc., a private medical technology company focused on advancing surgical wound healing, announced it has received CE Mark approval for the neoClose® Laparoscopic Port Closure device.
The CE Mark enables neoSurgical to sell and distribute neoClose® to the 28 countries in the European Economic Area.
"This marks a significant milestone for neoSurgical as we continue on our path of advancing surgical wound healing," stated Steve Anderson, Vice President Sales & Marketing of neoSurgical. "To date we have performed over 18,000 cases in the United States and we are now very excited to offer the benefits of neoClose® to the many surgeons and patients within Europe."
neoClose® brings a simple, intuitive and reliable solution to assist the surgeon in closing port site defects, up to 3cm, following laparoscopic abdominal surgery. By utilizing bio-absorbable anchors and a Vector-X closure, neoClose® is changing the standard of care in port site closure.
"neoClose® is a simple to use port closure device and is a handy adjunct in port site closure," stated Mr. Sean Johnston, General Surgeon, Midland Regional Hospital, Tullamore, Ireland.
neoClose® results in an approximation of the tissue with up to 75% less tension than conventional closure methods which utilize a closed loop closure method that has been associated with clinically significant pain due to nerve injury (Shin & Howard, 2012) and hernia rates as high as 39% (Scozzari et al., 2014). neoClose® can help lower these risks due to its unique reduced tension closure.
Today, an estimated 7 million laparoscopic procedures are performed globally each year. Each of these procedures results in multiple abdominal port site defects where neoClose® can be deployed. With the continued trend towards minimally invasive and robotic surgery, there will be a growing requirement for effective port site closures.
"In the future we look to expand into additional modalities to address some of the unmet clinical needs in both minimally invasive and open surgery. neoClose® is just the first of a platform of products neoSurgical is planning on commercializing to address the growing need of improving surgical wound healing," stated Ronan Keating, CTO of neoSurgical.
About neoSurgical
neoSurgical® is a commercial-stage company focused on being the global leader in advancing surgical wound healing. The company's initial product is neoClose®, approved for sale in the US and Europe and designed to be the new standard for Laparoscopic surgery port site closure, a potential $400 million opportunity. The company's neoClose® system for port site closure used in Laparoscopic surgery has now been used more than 18,000 times in hospitals across the United States.
To learn more, visit www.neosurgical.com
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SOURCE neoSurgical