Medigus obtains FDA 510(k) approval for GERD treatment system

24 March 2014 (Last Updated March 24th, 2014 01:00)

Israel-based Medigus has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its MUSE system, a minimally invasive treatment device for gastroesophageal reflux disease (GERD).

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Israel-based Medigus has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its MUSE system, designed to perform minimally invasive treatment of gastroesophageal reflux disease (GERD).

Previously known as SRS system for transoral fundoplication, MUSE is a single operator system that enables endoscopists to treat GERD by performing a fundoplication procedure through the mouth.

The next-generation system provides symptomatic chronic GERD patients with a potential long-term solution that aims to restore the esophageal anatomy with a minimally invasive tool in order to reduce or eliminate their GERD symptoms.

Medigus's new MUSE system incorporates an improved graphical user interface and is easier to use. The intuitive endosurgical platform consists of a single-use surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder.

The system uses LED illumination and advancements in one of the world's smallest video cameras to achieve enhanced, digital resolution and an improved field of view.

"This is an important achievement in our 2014 strategic plan, and allows us to focus on the implementation of a scalable commercial, clinical and physician training model through the establishment of 'centres of excellence' in the US."

It has a more compact console, motorised stapler ejection mechanism, software controls ensuring safe operation, and an alignment pin mechanism to ensure precise alignment prior to staple delivery. The new features complement existing elements such as ultrasound guidance and easy handling, enabling single operator surgery.

Medigus CEO Chris Rowland said FDA clearance of the MUSE system is a significant milestone for the company.

"This is an important achievement in our 2014 strategic plan, and allows us to focus on the implementation of a scalable commercial, clinical and physician training model through the establishment of 'centres of excellence' in the US," Rowland said.

In 2011, a multicentre clinical trial was completed and success was attained in the primary efficacy and safety endpoints according to the trial protocol. In 2007, a pilot study produced five-year follow-up results that are similar to results received in surgical laparoscopic procedures, considered the gold standard for GERD treatment.

The two studies were completed with a previous generation of MUSE, however they used the same surgical staples and stapling patterns as the new MUSE system.


Image: Medigus obtains FDA 510(k) approval for MUSE System. Photo: courtesy of PRNewswire/Medigus Ltd.