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neoClose indications expanded

neoSurgical expands neoClose laparoscopic indications

some 25% currently use a port site closure device, 5-50 percent of all laparoscopic incisions herniate, with a 10-45 percent chance of recurrence after a first hernia.

neoSurgical has expanded its neoClose product offerings to include port site incisions up to 30mm (3cm), which may include bariatric, colorectal and cholecystectomy Lap surgeries. The FDA-cleared neoClose device may now be used to close port site incisions from 5mm to 30mm (3cm) in length. With more than three million laparoscopic procedures annually in the US, some 25% currently use a port site closure device. However, 5-50 percent of all laparoscopic incisions herniate, with a 10-45 percent chance of recurrence after a first hernia. With laparoscopic surgery in-patient costs as high as US$30,000, herniation and recurring herniation add US$3 billion annually in costs to the US healthcare system.

“Surgeons in hospitals across the United States now have the opportunity to perform the gamut of standard laparoscopic surgeries using our neoClose device,” said Barry Russell, CEO of neoSurgical. “The reason that neoClose is being adopted so rapidly by Lap surgeons is because of the demonstrated clinical superiority of neoClose versus standard of care techniques for closing port sites - a decades-old standard, by the way, that must be recast in order to improve patient outcomes and safety.”

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)

Until 2014, trocar site hernia (TSH) complications were thought to occur at a reported rate of about 1-6% among the six million laparoscopic surgery port sites closed each year. A clinical study by Comajuncosas et al (Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study) reported that nearly 26% of patients were diagnosed with TSHs. Thus, TSHs have been grossly under-diagnosed. Following the Comajuncosas study, a second published study by Scozzari et al (High incidence of trocar site hernia after laparoscopic or robotic Roux-en-Y gastric bypass), the total trocar site hernia rate was 39.3% at three years. A third, multi-institutional study by Holihan JL et al (Adverse events after Ventral Hernia repair: The vicious Cycle of complications) revealed that hernia occurrence can lead to a repetitive cycle of repeat procedures and complications.

The standard for port site closure has been Closed Loop Suture. Now, there’s neoClose, which works by the use of a Vector X closure, approximating the tissue together and tying into place for a secure closure with up to 75% less tension compared to standard closed loop suture.

In January 2016, neoSurgical revealed that it has begun a Postmarket Surveillance Study of its FDA-cleared device, neoClose, at University of Texas Health Sciences Center at Houston, TX. The randomised study will compare neoClose against the standard of care for closure in a bariatric surgery gastric bypass population of 70 adults aged 18-70 years with BMI>35. Principal investigators include: Drs Erik B Wilson, Professor of Surgery; Peter A Walker, Assistant Professor of Surgery and Shinil K Shah, Assistant Professor of Surgery.

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 is approved for sale in the US and Europe. The company’s neoClose system for port site closure has now been used more than 7,000 times in hospitals across the US.

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