A bariatric device from Leeds-based company Surgical Innovations Group has received 510(k) clearance from the FDA for sale in the US.

The LogiFlex device is used in gastric band deployment and associated procedures. Its sterile insert allows the surgeon to fix gastric bands around the top of the patient's stomach.

A 'resposable' instrument, LogiFlex combines a reusable handle and a single-use insert. The US market traditionally uses disposable instruments for these procedures, but increasing pressure to reduce costs means that LogiFlex will appeal as a cost-effective alternative.

It is estimated that 250,000 anti-obesity procedures are performed annually in the US, where obesity affects more than 60 million people.

Graham Bowland, CEO of SI Group, said: "We are delighted to be able to announce this approval, which will see the pioneering device now being sold into the US. The majority of surgical instruments in the US are single use; however with growing financial constraints being placed on hospital budgets, procurement managers are continuously looking for cost-effective instrumentation and LogiFlex offers the ideal high-quality, cost-effective solution."

SI Group manufactures devices for use in minimally invasive surgery. It has pioneered 'resposable' instrumentation with single-use and reusable components, delivering an optimum performance to cost ratio.

Based in Leeds, SI sells in all major medical markets including North America and Europe through a network of distribution partners. The Group sells its own branded instruments as well as being an OEM provider to major medical device companies, including Olympus and CareFusion.

LogiFlex