Tagss Pyloroplasty

• Large unmet need
• Breakthrough designation with FDA
• Lack of significant competition
• Relatively simple procedure with limited learning curve

• Sizeable market:

  • 10% of population has diabetes mellitus
  • 10% of type-II diabetics have gastroparesis
  • Rising prevalence of diabetes associated with obesity epidemic
• Clear benefit shown for surgical pyloroplasty, but:
  • Technically difficult
  • Requires multiple incisions, general anesthesia, higher risks, and greater costs vs TAGSS pyloroplasty
• TAGSS pyloroplasty possible in outpatient setting without general anesthesia
• Well-defined, simple proof of efficacy (radiology, scintigraphy)

MTI Consensus Conference, Miami Beach, Florida – June 2025

“A syndrome of objectively delayed gastric emptying of solids in the absence of a mechanical obstruction: Effecting 10% of Type 11 Diabetics (~3 million Americans)”

Symptoms

• Extreme Nausea
• Vomiting
• Bloating
• Weight Loss
• Upper Abdominal Pain

Current Treatment Options

• G-POEM: Only available in academic centers
• Gastric Pacing: Only treats nausea
• Reglan & Gimoti (metaclopramide)
  • Cannot be taken more than 12 weeks
  • Tardive dyskinesia (involuntary muscle movements) listed as an irreversible  potential side effect
• Laparoscopic Pyloroplasty
  • Requires general anesthesia
  • Laborious and difficult for surgeons
  • Less than 5% of referred patients accepted by surgeons due to difficulty and risk of complications

• Early improvement of symptoms in 90–100% of patients
• Improves gastric emptying by 85–96%
• Normalizes radiologic & scintigraphy studies in 54–77%

Based on these results, surgical pyloroplasty should be considered as a primary treatment for gastroparesis. However, it is invasive and carries a high risk of complications.

Swanstrom, Surgical Endoscopy (2018)

“Hybrid pyloroplasty (TAGSS) is a feasible alternative for the treatment of gastric outlet obstruction syndrome. This approach retains the advantages of endoscopic and laparoscopic instruments while being less invasive than laparoscopic pyloroplasty. The procedure can be performed in a reasonable time and learned by surgeons and endoscopists with a short learning curve.”

— Swanstrom, Surgical Endoscopy, 2018

Image 1. Normal anatomy of the pylorus

Image 2. Placement of TAGSS device with laparoscopic stapler inserted Image 3. Completed pyloroplasty to facilitate gastric emptying

Fig. 6 Hybrid endoluminal stapled pyloroplasty Swanstrom, Surgical Endoscopy 2018