Ten years after it first won clearance from the Food & Drug Administration, Mederi Therapeutics Inc.’s Stretta treatment for gastro-esophageal reflux disease is hitting the market in the U.S.
CEO Will Rutan told MassDevice that the system, which uses radiofrequency waves to restore the function of the valve separating the esophagus from the stomach, first won 510(k) clearance from the FDA in 2000, when the technology was owned by Curon Medical Inc. Curon went bust in 2006, filing for Chapter 7 bankruptcy protection, and Mederi acquired its assets in 2008, Rutan told us. Mederi re-submitted the 510(k) application for the Stretta technology and won clearance about six months ago, he said.
The device is a balloon catheter containing a needle that delivers RF energy. Rutan said the system is inserted into the esophagogastric junction, the sphincter controlling the entrance of food into the stomach and preventing stomach acids from backing up into the esophagus.
"Our treatment induces collagen deposition. We create create small thermal lesions which reform the lower esophageal sphincter and restore it to normal function," Rutan said. "There are substantial, long-term data demonstrating high effectiveness rates and durability beyond four years, – so it not only works, but it lasts."
The company’s target markets are the 20 percent of patients with GERD who don’t respond to proton pump inhibitors such as Prilosec or Nexium and the 40 percent of patients who don’t respond to surgical treatment, he said.
The release was timed to coincide with the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons slated for April 14-17 in Landover, Md., Rutan said.
Mederi also makes a treatment for fecal incontinence, the Secca system, based on the same technology used in its Stretta device.