How It Works
A laparoscopic surgery means no new skills are needed for surgeons, and quick relief for patients with acid reflux.
CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.
Omega PF™ stands out from other treatment products in being a partial surround device (partial fundoplication) designed to control reflux yet allow easy swallowing. Less problems arise post-op due to the device not disrupting physiology or anatomy and its unique flexible architecture. Plus, the laparoscopic procedure does not require new surgical skills, allowing all qualified surgeons to easily replicate.
Several key opinion leaders in the field of gastroenterology and GI surgery have provided valuable input and advice for this project to complete the pre-clinical animal study without adverse events and achieve an FDA IDE approval for a clinical feasibility study. Three renowned surgeons, Drs. Reginald Bell, Tripp Buckley, and John Lipham, consented to be principal investigators for this NIH SBIR grant-supported clinical study (see patient recruitment brochure – PDF file). We look forward to Drs. Bell, Buckley, and Lipham, their co-investigators, and surgical teams to successfully completing the study.
Key factors of Omega PF:
- Omega PF is a nitinol device that is easy to manufacture.
- Omega PF’s design avoids dysphagia.
- The laparoscopic 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.
- This NIH SBIR grant supported clinical study is being conducted by three renowned surgeons and key opinion leaders in the GERD treatment field.
The Omega PF exemplifies ‘Aplos’—the Greek word for simplicity—through its design and functionality.
Omega Partial Fundoplication (Ω-PF) is a nitinol-based, flexible, non-occlusive device designed as a safe, durable, and simpler surgical option for GERD. The procedure is straightforward: surgeons measure the esophageal circumference for a device size, position the device, and secure it with two sutures without altering anatomy or physiology. Omega PF works in harmony with the esophageal swallowing process and reduces dysphagia and side effects common to other operations.
Omega PF has advanced through preclinical and clinical testing. The device passed ISO 10993 biocompatibility, corrosion, nickel leaching, and durability standards and is MRI compatible at 1.5 and 3.0 Tesla. In a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approved clinical feasibility study, all patients were discharged on the same day, demonstrated reduction in or discontinuation of targeted medications, and reported improved quality of life.
