Surgical Innovations Regulatory News (SUN)

Surgical Innovations Group plc

("SI" or "the Group")

FDA Approval for Logi®Flex

Surgical Innovations Group plc (AIM:SUN), the designer and manufacturer of innovative medical devices, is pleased to announce that it is has received 510(k) clearance from the US Food and Drug Administration ("FDA") for its Logi®Flex device.

This clearance permits the use of Logi®Flex in the US market for both gastric band deployment and other associated bariatric procedures.

Logi®Flex is a Resposable® articulating instrument which combines both reusable and disposable elements - the insert is single use and the handle is reusable - to offer surgeons a high quality and cost effective solution.

The device has a sterile insert which allows surgeons to fix gastric bands around the top of a patient's stomach. It also has a unique slot design which provides a positive grip on the suture allowing the band to be pulled into position with the minimum of inconvenience.

It is estimated that 250,000 anti-obesity procedures are performed annually in the US where obesity affects more than 60 million people, representing the second largest cause of preventable death.

Graham Bowland, Chief Executive Officer of the 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 Logi®Flex offers the ideal high quality, cost effective solution."

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About Surgical Innovations Group plc

Surgical Innovations Group plc specialises in the design and manufacture of innovative devices for use in minimally invasive surgery and industrial markets. The Group's main focus is on developing medical instruments for the laparoscopic surgery market - minimally invasive surgery of the abdomen.

Surgical Innovations has pioneered Resposable® instrumentation combining both single use and reusable components ensuring ongoing revenue streams and delivering the optimum procedure performance to cost ratio. 

Through an established network of 45 distribution partners, SI sells in all major medical markets including North America, Europe, South Africa, the Middle East, South-East Asia and Australia. The Group's strategy is to sell its own branded instruments as well as to provide large medical device companies on an OEM basis including Teleflex Medical, Gyrus, Olympus and CareFusion.

The Group's products include:

The Group employs over 100 people at its 32,000 square feet facility in Leeds, with in-house design and the manufacturing of products to the highest quality standards. 

 For more information, see www.surginno.com