Medrobotics gets CE Mark approval for first robot-assisted flexible endoscopic system

19 March 2014 (Last Updated March 19th, 2014 18:30)

Medrobotics has received CE Mark approval for its Flex system, a robotic-assist platform that enables surgeons to gain single-site access and visualisation to difficult-to-access anatomical locations.

Medrobotics has received CE Mark approval for its Flex system, a robotic-assist platform that enables surgeons to gain single-site access and visualisation to difficult-to-access anatomical locations.

With this approval, Medrobotics will initiate a limited commercial launch of the Flex system in select European markets. The company prepares for the European commercialisation of the Flex system in otolaryngology.

Medrobotics claims that the robotic-assist platform enables physicians to navigate the Flex endoscope around anatomical structures to hard-to-reach locations through a single access site, and then use the onboard high-definition vision system to precisely deploy a range of third-party flexible surgical instruments.

The uniquely wristed 3mm Flex instruments enables the surgeon to operate in confined spaces. It provides a unique platform to access and visualize surgical targets in difficult to reach locations such as the oropharynx and endolarynx.

"The system enables surgeons to access and visualise hard-to-reach anatomical locations and deploy specially designed flexible surgical instruments to perform procedures."

The Flex system is anticipated to provide a cost-effective, robot-assisted surgical platform for hospitals and surgeons eager to expand their offering of minimally-invasive treatment options to the broadest number of patients.

It provides a precise and stable platform for enhanced visualization and enables two-handed dexterousness with compatible third-party instruments having tactile feedback.

Medrobotics president and CEO Dr Samuel Straface said the Flex system is the first robot-assisted flexible endoscopic platform for use during surgical procedures.

"The system enables surgeons to access and visualise hard-to-reach anatomical locations and deploy specially designed flexible surgical instruments to perform procedures," Dr Straface said.

In November 2013, Medrobotics gained ISO 13485: 2003 Certification for the design, manufacture, service and distribution of the Flex system.

Medrobotics medical advisory board co-chair, professor and chairman emeritus of Cleveland Clinic Head and Neck Institute Dr Marshall Strome said: "With currently available technologies, we are often trading off between access, visualisation and two-handed surgery, but the Flex System gives us all three."

According to GlobalData estimates, the Flexible endoscopes market in Europe was valued at $813.4m in 2012 and is expected to grow at a CAGR of 3.9% to reach $1.06bn by 2019.