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Product approval

CE Mark Approval for neoClose Laparoscopic Port Closure Device

neoClose delivers two absorbable AutoAnchor into the abdominal wall, both consisting of a suture and an anchor

neoSurgical has received CE Mark approval for the neoClose Laparoscopic Port Closure device, allowing the company to sell and distribute neoClose to the 28 countries in the European Economic Area. According to the company, 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 utilising bio-absorbable anchors and a Vector-X closure, neoClose is changing the standard of care in port site closure. 

"This marks a significant milestone for neoSurgical as we continue on our path of advancing surgical wound healing," said 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 delivers two absorbable AutoAnchor into the abdominal wall, both consisting of a suture and an anchor. The sutures are knotted at the end of a procedure, facilitating approximation of the incision (Figure 1).

Figure 1: neoClose Overview (Credit: neoSurgical)

neoClose’ method of approximation (Vector X) is associated with reduced tension at wound sites compared to more traditional methods of closed loop approximation (Figure 2). According to the company, closed loop approximation in the lower abdomen is associated with a 5% risk of clinically significant pain due to nerve injury. neoClose has the potential to lower this risk, due to reduced tension.

Figure 2: Less Stress with neoClose means potential to reduce complications from port site closure following lap surgery. Sources - 1. Shin JH, Howard FM. Abdominal wall nerve injury during laparoscopic gynecologic surgery: incidence, risk factors, and treatment outcomes. J Minim Invasive Gynecol. 2012 Aug;19(4):448–53. 2. Nawaz Z, Bentley G. Surgical incisions and principles of wound healing. Basic Ski. 2011 Feb;29(2):59–62. 3. Greenberg JA, Clark RM. Advances in suture material for obstetric and gynecologic surgery. Rev Obstet Gynecol. 2009;2(3):146–58. 4. Independent Study completed by the National University of Ireland, Galway. Data on file at neoSurgical. (Credit: neoSurgical)

The company believes that minimising wound tension contributes to a suitable environment for optimal wound healing, as over-tightened sutures can lead to tissue necrosis and excessive tissue overlap, which results in reduced tensile strength in the healed tissue.

neoClose has been report to result 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," said Ronan Keating, CTO of neoSurgical.

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