Excisionless Device for GERD Surgery Launched
The EsophyX, from EndoGastric Solutions, received approval from the FDA. The device is used to perform transoral incisionless fundoplication (TIF) surgery to treat patients with gastroesophageal disease (GERD). The press release was published by EndoGastric.
The single use device allows completion of endoluminal fundoplication. The tissue can be reorganized to create a gastroesophageal valve, as well as reducing hiatal hernias. Both of these are tactics to reduce the symptoms that arise from GERD. The tool is intended to deliver the same therapeutic benefits as laparoscopic fundoplication, while minimizing the risks that arise secondary to incisions.
The tool eliminates the need for three to six incisions, as are frequently used to complete procedures laparoscopically. But it still completes all the tasks that would otherwise be conducted laparoscopically, including recreation of the valve, cardia calibration, lengthening of the esophagus, and minimizing hiatal hernia. Procedures completed in such a manner are based on the natural orifice approach or natural orifice surgery (NOS).
This is the second product launch for EndoGastric in the United States. The product had already received the CE mark for European marketing.
An additional product was recently approved to improve the health of patients with GERD that is not surgical in nature. The Plicator II implant allows restoration of the gastric cardia endoscopically, as detailed on Hospital Buyer
September 27, 2007 Related topics: Product Approval & Certification, New Technology & Innovation, Surgery, Gastroenterology