The FDA has granted Breakthrough Device Designation to Endo-TAGSS, a minimally invasive system designed for patients with medically refractory gastroparesis. The device — a percutaneous intragastric trocar — lets surgeons perform pyloroplasty using standard laparoscopic tools inside the stomach. It's a potential game-changer for patients who've exhausted medications and have limited surgical options.
For patients with severe gastroparesis who've tried everything and hit a wall, a new device may offer a way forward. The FDA has granted Breakthrough Device Designation to Endo-TAGSS's Trans-Abdominal Gastric Surgical System (TAGSS) — a sterile, single-use, 12-mm percutaneous intragastric trocar that enables minimally invasive pyloroplasty (pyloric dilation) using standard laparoscopic instruments inside the stomach.
The device is placed endoscopically — similar to a pull-type PEG tube — and creates an airtight seal against the gastric wall. A built-in CO₂ insufflation port inflates the stomach, giving surgeons broad working access to the stomach and pylorus. Gastroparesis, a chronic condition causing delayed gastric emptying, leads to debilitating nausea, vomiting, bloating, and weight loss — and in diabetic patients, it can severely disrupt blood sugar control.
By the Numbers:
Why it matters: Most gastroparesis patients eventually exhaust medication options, and traditional surgical alternatives are complex procedures performed at only a handful of centers. Breakthrough Device Designation signals FDA recognition of a significant unmet need — though it does not guarantee eventual approval.
