OverStitch NXT™ NeXT Generation Single-Channel Endoscopic Suturing System

• OverStitch NXT™ is an endoscopic suturing system designed for use on single-channel gastroscopes and compatible with a wide range of gastroscopes across multiple manufacturers.
• Provides reliable suturing regardless of anatomy site or type of treatment.¹ In a clinical study, patients achieved long-lasting weight loss results via bariatric endoscopic approach.²
• NXT Tissue Helix Pro’s physician-controlled tissue acquisition and suturing capabilities may help to minimize the need for an experienced assistant to operate the device.³

• Full-Thickness Endoscopic Suturing - Tissue approximation by placement of anchor-sutures for endoscopic bariatric procedures and defect closure in therapeutic endoscopic procedures.
• Advanced Scope Retroflexion - MaxFlex advanced scope retroflexion provides physicians with the ability to supplement control of the retroflexion capabilities of their endoscope.
• Physician-Controlled Tissue Acquisition Option - NXT Tissue Helix Pro gives the physician full device control over tissue acquisition and suturing. OverStitch NXT™ is also compatible with the Assistant-controlled Tissue Helix.

GI procedures

Traditional clips may offer a quick solution for closing small defects but are limited by their size and rely on mucosal fixation. Using multiple clips to close a larger defect may increase costs. The OverStitch NXT™ Endoscopic Suturing System allows you to close defects and engage healthy tissue giving you advantage to address defects of multiple sizes and tissue qualities. Full thickness suturing incorporates the muscle layer and allows a stable construct during the healing process.

With the ability to customize suture patterns, the OverStitch NXT™ Endoscopic Suturing System allows you to place running sutures to approximate either a small or large area of tissue. Additional sutures can be placed as needed to enhance construct stability.

Bariatric procedures

The OverStitch NXT™ Endoscopic Suturing System allows you to place durable full-thickness sutures in a wide range of endobariatric procedures such as Endoscopic Sleeve Gastroplasty (ESG) and Transoral Outlet Revision.

When used to perform ESG, the OverStitch NXT™ System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through ESG in adult patients with obesity who have not been able to lose weight, or maintain weight loss, through more conservative measures.

• The IFSO Bariatric Endoscopy Committee endorses Endoscopic Sleeve Gastroplasty (ESG) as an effective and valuable treatment for obesity.⁴ The IFSO position statement is based on a systematic review and meta-analysis of the available literature on ESG with OverStitch™. The systematic review included 44 articles encompassing 15,714 patients receiving ESG. These results demonstrate significant weight loss following ESG. The pooled serious adverse event (SAE) rate was 1.25%.⁵
• ESG procedure reduces stomach volume and delays gastric emptying, resulting in earlier satiety and weight loss.
• Patients lose an average of 13.6% of total body weight at 1 year, according to a level 1 clinical evidence study⁶.
  
• The body of evidence supporting the safety, effectiveness, and durability of the ESG procedure has been developed over 10 years and includes both level 1 evidence and large meta-analyses.
  
• The Multicenter Endoscopic Sleeve Gastroplasty Randomized Interventional Trial (MERIT) evaluated the safety and effectiveness of ESG versus a medically monitored regimen of diet and healthy lifestyle over a 2-year period.