The trial, which is being conducted at 15 academic and private medical centers in the US and Europe, will evaluate the safety and effectiveness of the Linx system in patients suffering from gastroesophageal reflux disease (GERD) despite medical therapy.
According to Torax Medical, the Linx reflux management system is intended to restore the normal barrier function in the esophagus for patients who suffer from GERD and is designed to be an outpatient, minimally invasive procedure. The device is implanted laparoscopically, with the patient likely to resume normal activities and diet at discharge.
In addition to its therapeutic benefits, Torax Medical anticipates that the Linx system will have the potential to eliminate the burdens associated with lifelong drug therapy and the typical complications associated with conventional surgical repair.
Todd Berg, president and CEO of Torax Medical, said: “We believe the simplest approach to treating GERD is to augment the body’s existing sphincter so that it can function normally. Excellent clinical results were achieved in feasibility trials with the Linx system and we expect these positive clinical outcomes to continue in this pivotal trial.”