First FSIE Patients Implanted in the NECTAR Trial

FSIE Investigators are part of a multi-center trial testing a new endoscopic therapy for patients with early GERD interested in eliminating or decreasing their dependence on medical therapy: NECTAR Pivotal Trial 
Aluvra, also known as Durasphere, has been used to treat stress urinary incontinence for over 18 years and is now under study at the GEJ to treat GERD. Aluvra is an injectable bulking material composed of >99% non-pyrogenic carbon beads, coated with pyrolytic carbon and suspended in a biocompatible, water-based carrier gel containing beta glucan, which provides lubricity to aid in the beads' delivery down the lumen of the delivery catheter. This substance, when injected submucosally at the GEJ, creates bulking of the submucosal tissue in the area of the LES. Over time collagen is deposited around the beads, creating an encapsulated fibrous sheath around the injected particles that produces tissue bulking and improved coaptation of the LES/GEJ, ultimately preventing gastroesophageal reflux. A small pilot study has shown very promising results with the endoscopic out-patient procedure (Ganz et al, Gastrointest Endosc. 2009). The study shows that the procedure was well tolerated with minimal patient discomfort and no dysphagia. At 12 months, 90% of patients reduced PPI use by greater than 50% and 70% discontinued all antacid medication completely. There was no esophagitis, no erosion, ulceration or sloughing of material was noted at any injection site and the beads did not appear to migrate. FSIE enrolled it's first 3 patients this week.