Apollo Endosurgery Inc (NASDAQ:APEN) Gets FDA Nod For OverStitch™ Sx Endoscopic Suturing System


Apollo Endosurgery Inc (NASDAQ:APEN) reported that it has received a clearance from U.S. FDA for OverStitch Sx. Flexible endoscopic suturing utilizing company’s existing version of OverStitch is a vital tool for both gastroenterologists and surgeons, but it is presently only compatible with a limited count of dual channel endoscopes and doctors without access to this particular capital equipment cannot pull the benefits of endoscopic suturing.

The details

OverStitch Sx eliminates this access constraint, and will work with most single channel endoscopes having diameters in between 8.8 mm and 9.8 mm. Once launched, the combination of the prevailing version of OverStitch Sx and OverStitch will offer most physicians access to the many advantages of flexible endoscopic suturing irrespective of their hospital’s choice of endoscope manufacturer or endoscopic capital equipment.

The OverStitch Sx, in addition to increasing endoscope compatibility, is projected to offer maneuverability and optimal visualization for the physician. Christopher Gostout, MD, the Chief Medical Officer at Apollo, expressed that endoscopic suturing is rapidly becoming an international standard of care for different endoscopic procedures supported by an increasing level of clinical evidence.

The release of OverStitch Sx will enable suturing know-how to be available to almost any physician with convenient access to an endoscope. This will enable for greater patient access to numerous minimally invasive endoscopic treatments. The company intends to launch the Sx system in the United States and Europe in 1H2018.

The OverStitch™ is meant for endoscopic placement of sutures as well as approximation of soft tissue. It allows advanced endoscopic surgery by permitting physicians to insert full-thickness sutures using a flexible endoscope. This latest know-how allows a protected approximation of tissue endoscopically and enables a broad range of less invasive offerings for physicians who cure defects in both the lower and upper GI tract of their patients.

In the last trading session, the stock price of Apollo Endosurgery jumped 33% to close the day at $5.40.

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