Device for Treatment of Gastro-Esophageal Reflux Disease (GERD) – Case History 8

Gastro-Esophageal Reflux Disease (GERD) close_up
Close-up of opened distal tip showing implant deployment mechanism

Market
Upper GI Endo-Surgery

Client Type
VC-funded startup (NDO Surgical)

Unmet Need
Minimally-invasive treatment for reflux disease that is less traumatic than current surgical practice (Nissen fundoplication) and more effective than drugs, including proton pump inhibitors like Prilosec.

Approach
Develop a trans-esophageal instrument capable of forming a full-thickness plication (fold) in the stomach wall just below the gastro-esophageal junction (GEJ). The instrument deploys a soft implant to maintain the plication. This plication tightens the GEJ and prevents reflux of stomach acids into the esophagus.

Gastro-Esophageal Reflux Disease (GERD)Product Features
50fr shaft conducts gastroscope into stomach. Controls on ergonomic handle provide control of distal articulation, jaw opening/closing, extension/retraction of tissue screw, and deployment of implant. Implant comprised of two soft pledgets (pads) connected by sutures. Procedure done under topical anesthesia in a doctor’s office in as little as 10 minutes. FDA approved and on the market.

Services Provided by OTI

  • Mechanical engineering, including design of unique articulating vertebrae, transmission mechanism, control cabling, molded silicon part design, injection molded part design & vendor sourcing
  • Development of assembly methods, including bonding, overmolding and fastening
  • FDA-compliant drawings
  • Prototyping
  • Verification & validation testing
  • Transfer to manufacturing

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