ST. PAUL, Minn.--(Torax Medical Inc., a medical device company focused on the minimally invasive treatment of gastro-esophageal reflux disease (GERD), has received CE Mark for its LINX® Anti-Reflux treatment. The company has started commercial launch of the LINX device at select centers in Europe.)--
“CE Mark approval for the LINX device is the first in a family of products to address clinical conditions benefiting from magnetic sphincter augmentation”
Patients with GERD typically experience burning pain and tissue damage, the result of stomach juices refluxing into the esophagus. This is due to a defective esophageal sphincter muscle between the esophagus and the stomach. These juices, which include acid and bile, are harmful to the lining of the esophagus and are prevented from entering the esophagus when the sphincter muscle is normal. The LINX device is designed to augment an abnormal sphincter and restore its barrier function.
“The LINX device has been implanted in over 150 patients in Europe and the U.S. as part of clinical trials. With CE Mark, our focus is commercial release in Europe with centers which are known thought leaders in the treatment of the disease. We will continue our collaboration with these select centers as they start providing this new treatment option for their patients,” said Todd Berg, CEO of Torax Medical.
Luigi Bonavina, Professor of Surgery at University of Milano and Chief of Surgery at Policlinico San Donato University Hospital, who has completed nearly 50 LINX procedures, said, “we are pleased that Torax has received CE Mark and are eager to continue our experience with LINX through a newly formed clinical Registry. The Registry data will be critical as we expand this needed treatment option for GERD patients.”
Approximately 7-10% of adults in western countries suffer daily from the symptoms of GERD. Physicians recognize that many patients continue to have GERD-related symptoms despite taking prescribed acid suppression medications. Patients refractory to drug therapy are often not comfortable electing the current surgical treatment options, therefore leaving many patients within a treatment gap. Chronic exposure of the esophagus to reflux may lead to numerous complications including ulcerations, Barrett’s esophagus and esophageal cancer. The incidence of esophageal cancer is increasing at the fastest rate among all types of cancer in the U.S.
“CE Mark approval for the LINX device is the first in a family of products to address clinical conditions benefiting from magnetic sphincter augmentation,” said Timothy Mills, Managing Director with Sanderling Ventures and Chairman of Torax Medical.
About the LINX Anti-Reflux Device
The LINX device is a ring of interlinked, miniature titanium beads with magnetic cores. The device is placed around the esophagus just above the stomach using a standard laparoscopic procedure. The design is intended to augment the existing sphincter, preventing it from opening to acid and other reflux. When swallowing, the beads can momentarily separate, allowing food to pass into the stomach; magnetic attraction between beads helps the device to close. Patients are expected to resume normal activities and a normal diet upon discharge. In the U.S., the LINX System is not approved for commercial distribution and is currently limited by Federal law to investigational use.
About Torax Medical
Torax Medical Inc. is a privately held medical device company focused on the medical application of its platform technology to restore human sphincter functions. For more information, please visit www.toraxmedical.com.