FDA 510(k) approval for reusable PretzelFlexT

RNS Number : 3850Z

Surgical Innovations Group PLC

15 March 2012

 



Surgical Innovations Group plc

("SI" or the "Company")

FDA 510(k) approval for reusable PretzelFlex™

Surgical Innovations Group plc (AIM: SUN), the designer and manufacturer of creative solutions for minimally invasive surgery ('MIS'), is pleased to announce that it has received 510(k) clearance from the US Food and Drug Administration ('FDA') for its Reusable PretzelFlex™ device.

This clearance permits the use of PretzelFlex™ in the US market for organ and tissue retraction. The device is easily inserted through a 5mm laparoscopic port and when deployed, forms the unique pretzel shape by way of patented segment technology. The PretzelFlex™ device is noted for its strength and stability to support large organs, which makes it a particularly useful tool in minimally invasive obesity surgery.

At the recent SAGES congress (Society of American Gastrointestinal and Endoscopic Surgeons) in San Diego the PretzelFlex™ product attracted significant interest from attending US surgeons. The Board looks forward with confidence to the forthcoming product launch.

Graham Bowland, Chief Executive Officer, commented: "I am delighted we have attained FDA approval for the PretzelFlex™ device, especially given the rapturous reception the product received at SAGES. The approval allows us to launch the product into the US market, which we previously stated is a strategically important market for the Company, and further, shows our importance as a leading designer and manufacturer of MIS devices."

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Enquiries:

Surgical Innovations Group plc	www.surginno.com
Doug Liversidge, Non-Executive Chairman
Graham Bowland, Chief Executive Officer	Tel: [phone] [e-mail]
Seymour Pierce Limited	www.seymourpierce.com
Freddy Crossley / Sarah Jacobs (Corporate Finance)	Tel: [phone]
David Banks / Jacqui Briscoe (Corporate Broking)
Walbrook PR Ltd	Tel: [phone]
Paul McManus	Mob: [phone] or [e-mail]
Fiona Henson	Mob: [phone] or [e-mail]

Notes to Editors:

About Surgical Innovations Group plc

Surgical Innovations Group plc specialises in the design and manufacture of innovative devices for use in minimally invasive surgery (MIS) and industrial markets. 

As well as manufacturing single-use and reusable instruments for the laparoscopic market, the Group has pioneered its flagship Resposable® instrumentation combining both single use and reusable components, ensuring ongoing revenue streams and delivering the optimum procedure performance to cost ratio.

Around 130 people are employed at the Group's 32,000 square feet facility in Leeds, with in-house design, plastic injection moulding and manufacturing equipment, producing products to the highest quality standards.

The Group's patented products are sold through three main channels:

SI brand	Through an established network of 45 distribution partners, Surgical Innovations branded products are sold in all major medical markets including North America, Europe, South Africa, the Middle East, South-east Asia and Australia.
OEM and IP	The Group supplies large medical device companies on an OEM basis, collecting sales fees as well as IP license and royalty fees.  Clients include Teleflex Medical, Gyrus and CareFusion.
Industrial	SI's patented segment technology has been applied to the industrial market enabling customers to undertake inspection and maintenance of large-scale equipment, such as turbines, in situ with minimum disassembly and downtime.

For more information, see www.sigrouplplc.com

 

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