FDA Grants Breakthrough Device Designation for EndoStim’s GERD Treatment - JD Supra

EndoStim announced connected October 25th that the FDA granted a breakthrough instrumentality designation for the company’s implantable neurostimulation attraction for cause refractory gastroesophageal reflux illness (GERD).

EndoStim states that its EndoStim System is the first-in-class implantable neurostimulation attraction for GERD. While traditional surgery for the attraction of GERD requires wrapping the tummy astir the little esophagus to fortify a patient’s little esophageal sphincter musculus (LES), this strategy attempts to supply semipermanent reflux suppression by automatically delivering tiny electrical signals to the LES. EndoStim states the strategy accomplishes this done usage of a neurostimulator and an implantable bipolar lead, and that the pb is placed wrong the diligent done a minimally invasive laparoscopic procedure, and a doc past programs the neurostimulator utilizing a wireless outer programmer.

While the EndoStim System is not yet approved for sale successful the U.S., aggregate semipermanent studies, specified arsenic a University of Vienna study and a German study, connected electrical implants aiding GERD utilizing this strategy person been reported to person recovered a sustained betterment successful GERD outcomes post-procedure. In discussing the announcement, EndoStim’s main enforcement officer, Eric Goorno, stated:

We are pleased that the FDA has recognized the therapeutic imaginable of the EndoStim System arsenic a caller attraction successful improvement for cause refractory GERD.… Our extremity is to bring this caller therapy to patients arsenic rapidly arsenic possible. We look guardant to moving intimately with the FDA to expedite the reappraisal of the EndoStim System.

The breakthrough instrumentality designation programme is designed to supply patients and wellness attraction providers with timely entree to aesculapian devices for much effectual attraction oregon diagnosis of life-threatening oregon irreversibly debilitating diseases oregon conditions by speeding up their development, assessment, and review. The FDA precocious updated its draught guidance for its breakthrough instrumentality designation programme to absorption connected reducing wellness and healthcare disparities based connected race, sec, ethnicity, and entree to care.

This twelvemonth it is reported that the FDA granted 120 breakthrough instrumentality designations done August 3, 2022. Since the program’s inception successful 2015, the breakthrough instrumentality designation programme is reported to person seen 54 devices person selling authorization.