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Jump to Key Points The FDA has granted Breakthrough Device Designation to the Trans-Abdominal Gastric Surgical System (TAGSS; Endo-TAGSS) for use in patients with medically refractory gastroparesis.
The TAGSS system is a sterile, single-use percutaneous intragastric trocar that enables physicians to use standard laparoscopic instruments inside the stomach to help achieve pyloric dilatation (pyloroplasty). The 12-mm device is placed endoscopically, similar to a pull-type percutaneous endoscopic gastrostomy tube. Once in place, it creates an airtight seal against the gastric wall, allowing the stomach to be inflated through a built-in carbon dioxide insufflation port, giving surgeons broad working access to the stomach and pylorus. A soft dilator tip facilitates placement.
Gastroparesis, a chronic disorder of delayed gastric emptying in the absence of mechanical obstruction, can cause severe nausea, repeated vomiting, bloating, upper abdominal pain, and unintended weight loss. In people with diabetes, it may make blood sugar regulation problematic.
Citing a 2018 study, Endo-TAGGS reported on its website that surgical pyloroplasty yields early improvement in symptoms in 90%-100% of patients, improves gastric emptying by 85%-96%, and normalizes radiologic and scintigraphy studies in 54%-77% of patients.
- FDA granted Breakthrough Device Designation to Endo-TAGSS for medically refractory gastroparesis.
- TAGSS = sterile, single-use percutaneous intragastric trocar.
- Enables standard laparoscopic instruments inside stomach for pyloroplasty/pyloric dilation.
- 12-mm endoscopic placement; airtight gastric seal + CO2 insufflation port.
- Gastroparesis can cause nausea, vomiting, bloating, pain, weight loss; diabetes complicates glycemic control.
“Patients with severe gastroparesis often run out of options,” said Craig Davidson, MBA, chief executive officer of Endo-TAGSS. “Medications stop working or cannot be used long-term, and the surgical alternatives are demanding procedures that few centers perform. Breakthrough Device Designation is an important validation of the TAGSS system and of the unmet need it addresses.”
According to the FDA, Breakthrough Device Designation does not change the requirements for marketing authorization and does not guarantee that a device will be authorized.
Marilynn Larkin, MA, is an award-winning medical writer and editor based in New York City whose work has appeared in numerous publications.
