How It Works
A simple laparoscopic surgery means no new skills needed for medical professionals and quick and easy relief for patients with acid reflux.
Omega PF™’s main differentiator from other competitors on the market is that it is a partial surround device (partial fundoplication) with a mechanical advantage for swallowing. Less problems arise post-op due to the device’s intuitive design, allowing it to not disrupt physiology or anatomy. Plus, the surgury takes less than an hour, and does not require any new training or skills from the medical staff.
Several key opinion leaders in the field of gastroenterology and GI surgery have provided valuable input and advice on this project including Robert A. Ganz, MD, an ASGE Schindler awardee. We look forward to continuing our working relationship with Dr Ganz on the medical advisory board, and others, as the product moves to the clinical testing stages.
Some other key factors:
- Omega PF™ is a nitinol device that is easy to manufacture.
- Omega PF™’s design avoids dysphagia.
- The simple surgery means no nerve manipulation.
- Omega PF™’s large, flat footprint minimizes erosion.
- Omega PF™ does not prevent patients from receiving MRI diagnostic procedures.
- Omega PF™ did not have any adverse events in its GLP animal study.
- Omega PF™ has passed all FDA required pre-clinical safety and efficacy study requirements, and has been granted an IDE to begin clinical studies.
