Now physicians can utilize the latest-generation high definition (HD) endoscopes when performing Transoral Incisionless Fundoplication (TIF®) procedures to treat the underlying, anatomical causes of GERD
SAN MATEO, Calif. (Dec. 10, 2014)–EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced the launch of the EsophyX®2 HD (high definition), the latest-generation of the company’s EsophyX® platform.
The new system allows surgeons and gastroenterologists to use a wider selection of endoscopes–including larger high-definition versions—when performing Transoral Incisionless Fundoplication (TIF®) procedures to treat the underlying anatomical causes of GERD.
The new device, which received 501(k) clearance from the U.S. Food and Drug Administration in September, is available in the U.S and is the second product iteration in the past 18 months.
“We developed the EsophyX®2 HD device to be compatible with a wider range of endoscopes, including the latest generation high-definition scopes, that generally have larger diameters than traditional devices,” said Skip Baldino, President and CEO of EGS. “Now, physicians with either traditional scopes or the latest endoscopic imaging technology may choose the scientifically proven TIF procedure for select patients.”
“Insertion was essentially no different from the previous devices; overall, a great experience,” said Peter Janu, M.D. of Wisconsin.
Michael Murray, M.D. of Nevada commented, “Much better visualization of fastener deployment.”
“As with all of our innovations, it is our goal to continually improve our products and make them easier to use,” said Darren Crow, General Manager at EGS. “It is our belief that this particular iteration will enable improved intraoperative visualization, and provide customers with a broader range of high-resolution scope compatibility.”
The new model of EsophyX®2 HD accommodates HD endoscopes while retaining the functionality, features and many dimensions of the EsophyX2 Plus device. EGS engineers increased the endoscope channel diameter of EsophyX2 HD to accommodate a broad range of commercially available endoscopes and it is compatible with the existing 6.5 mm and 7.5 mm SerosaFuse® Implantable Fastener cartridges.
About GERD
Gastroesophageal Reflux Disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to wash back up into the esophagus, causing heartburn and possible injury to the esophageal lining. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.
GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 23 million people two or more times per week in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g. diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum dose usage of prescription medications has been linked to a variety of other health complications.
About the EsophyX® device
The original EsophyX device was FDA-cleared in 2007, and is commercially available in the United States. Inserted through the patient’s mouth with visual guidance from an endoscope, the EsophyX device is used to reconstruct the gastroesophageal valve (GEV) in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
Performed entirely through the mouth without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.
The TIF procedure has an established safety and efficacy profile with more than 16,000 patients treated worldwide. For more information, visit www.GERDHelp.com.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in San Mateo, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to combine the most advanced concepts in gastroenterology and surgery to develop products and procedures that address unmet needs in gastrointestinal diseases.
Contacts:
Debbie Donovan
EndoGastric Solutions, Inc.
Phone: 650-578-5120
ddonovan[at]endogastricsolutions[dot]com
Hollister Hovey
Lazar Partners, LTD
Phone: 646-871-8482 (direct)
hhovey[at]lazarpartners[dot]com
Twitter: @GERDHelp
Facebook: GERDHelpcom
Google+: GERDHelp
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
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NP02405-04A
