FDA Grants Breakthrough Device Designation for EndoStim’s GERD Treatment
EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD).
EndoStim states that its EndoStim System is the first-in-class implantable neurostimulation treatment for GERD. While traditional surgery for the treatment of GERD requires wrapping the stomach around the lower esophagus to strengthen a patient’s lower esophageal sphincter muscle (LES), this system attempts to provide long-term reflux suppression by automatically delivering small electrical signals to the LES. EndoStim states the system accomplishes this through use of a neurostimulator and an implantable bipolar lead, and that the lead is placed within the patient through a minimally invasive laparoscopic procedure, and a physician then programs the neurostimulator using a wireless external programmer.
While the EndoStim System is not yet approved for sale in the U.S., multiple long-term studies, such as a University of Vienna study and a German study, on electrical implants aiding GERD using this system have been reported to have found a sustained improvement in GERD outcomes post-procedure. In discussing the announcement, EndoStim’s chief executive officer, Eric Goorno, stated:
The breakthrough device designation program is designed to provide patients and health care providers with timely access to medical devices for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment, and review. The FDA recently updated its draft guidance for its breakthrough device designation program to focus on reducing health and healthcare disparities based on race, sec, ethnicity, and access to care.
This year it is reported that the FDA granted 120 breakthrough device designations through August 3, 2022. Since the program’s inception in 2015, the breakthrough device designation program is reported to have seen 54 devices receive marketing authorization.