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FDA approves Medrobotics’ Flex System for colorectal procedures

Wed, 08/16/2017 - 12:10
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The minimally invasive Flex Robotic System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point to operate in difficult-to-reach places

Medrobotics has received FDA regulatory clearance to market the Flex Robotic System for colorectal procedures in the US. According to the company, it is the first and only company to offer minimally invasive, steerable and shapeable robotic products for colorectal procedures in the US. The Flex Robotic System is the world’s first robotic surgical platform to offer Scarfree access to hard-to-reach anatomy in otolaryngology and colorectal procedures. This provides surgeons treatment options that may not be possible with straight, rigid instruments.

“The human gastrointestinal system is full of twists and turns, and rigid surgical robots were not designed to operate in that environment. The Flex® Robotic System was. Two years ago, Medrobotics started revolutionizing treatment in the head and neck in the US. We can now begin doing that in colorectal procedures,” said CE, Dr Samuel Straface. “American hospitals, surgeons and patients will be able to enjoy the benefits of the world’s only flexible, surgical robotic platform. It will easily integrate into hospitals due to its mobility and short learning curve.”

 Flex Robotic System
 Flex Robotic System

The minimally invasive Flex Robotic System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point to operate in difficult-to-reach places. Today, access is gained through the mouth and anus. In future applications, access may be obtained through other natural orifices such as the vagina, or through small incisions in the abdomen. Medrobotics is developing new surgical applications for its core platform technology in the areas of general surgery, gynaecology, and urology, among others. These new applications are not yet cleared for use in the US.

"The Flex Robotic System offers the promise to treat select colorectal patients transanally with a more consistent and an easier approach because it overcomes the limits of straight surgical instrumentation,” said Dr Alessio Pigazzi, Professor of Surgery at the University of California, Irvine. “Medrobotics is ushering in the first of a new generation of shapeable and steerable robotic surgical systems that offer the potential to reduce the invasiveness of surgical procedures for more patients.”

Medrobotics received its initial FDA clearance for the Flex Robotic System in July 2015, and the CE Mark in March 2014.