Medigus Ltd. (TASE:MDGS) Ltd. (TASE: MDGS), a medical device company developing minimally invasive endosurgical tools and procedures, announced today that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the next generation MUSE system (formerly known as the SRS system).
MUSE enables an incisionless procedure by performing an anterior partial fundoplication with standard surgical staples in a less invasive way. The procedure currently targets patients with symptomatic chronic gastroesophageal reflux disease (GERD), one of the most common chronic diseases in the Western world. The MUSE system provides these patients, who are typically at higher risk of developing esophageal cancer, with a potential long-term solution which aims to restore the esophageal anatomy with a minimally invasive tool in order to reduce or eliminate their GERD symptoms.
“FDA clearance of the MUSE system is a significant milestone for Medigus and will allow patients in the US to have access to the most advanced technology for treating GERD,” said Medigus CEO Chris Rowland, “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 'centers of excellence' in the US It also positions our company for sustained, significant long-term growth and becoming a leader in the field of minimally invasive endosurgical devices.”
The new MUSE system is easier to use, with an improved graphical user interface. It leverages LED illumination and advancements in one of the world’s smallest video cameras to achieve enhanced, digital resolution and an improved field of view. The surgical endoscope remains disposable, ensuring patient safety.
Published by Globes [online], Israel business news - www.globes-online.com - on March 23, 2014
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