12.10.14
San Mateo, Calif.-based EndoGastric Solutions (EGS), which makes incisionless procedural therapy for gastroesophageal reflux disease (GERD), has released Esophyx2 HD (high definition), the latest-generation of the company’s Esophyx platform.
The original Esophyx device was cleared by the FDA in 2007. It is inserted through the patient’s mouth with visual guidance from an endoscope, and is used to reconstruct the gastroesophageal valve in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.
The new system is deigned to provide 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 (FDA) in September, is available in the United States and is the second product iteration in the past 18 months.
“We developed the Esophyx2 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 President/CEO Skip Baldino. “Now, physicians with either traditional scopes or the latest endoscopic imaging technology may choose the scientifically proven TIF procedure for select patients.”
“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 Esophyx2 HD accommodates HD endoscopes while retaining the functionality, features and many dimensions of the Esophyx2 Plus device. The new version has an increased endoscope channel diameter to accommodate a broader range of endoscopes.
The original Esophyx device was cleared by the FDA in 2007. It is inserted through the patient’s mouth with visual guidance from an endoscope, and is used to reconstruct the gastroesophageal valve in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.
The new system is deigned to provide 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 (FDA) in September, is available in the United States and is the second product iteration in the past 18 months.
“We developed the Esophyx2 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 President/CEO Skip Baldino. “Now, physicians with either traditional scopes or the latest endoscopic imaging technology may choose the scientifically proven TIF procedure for select patients.”
“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 Esophyx2 HD accommodates HD endoscopes while retaining the functionality, features and many dimensions of the Esophyx2 Plus device. The new version has an increased endoscope channel diameter to accommodate a broader range of endoscopes.