Surgical Innovations Group plc
("SI" or the "Company")
FDA 510(k) approval for reusable 3mm PretzelFlex™
Surgical Innovations Group plc (AIM: SUN), the designer and manufacturer of creative solutions for minimally invasive surgery ('MIS'), announces that it has received 510(k) clearance from the US Food and Drug Administration ('FDA') for its Reusable 3mm PretzelFlex™ device.
This clearance permits the use of the 3mm PretzelFlex™ in the US market for organ and tissue retraction. The device is easily inserted through a 3mm laparoscopic port and when deployed, forms the unique pretzel shape by way of patented segment technology. The 3mm PretzelFlex™ device combines strength and stability within a significantly reduced profile to support organ retraction through a smaller port incision, which makes it a particularly useful tool in minimally invasive paediatric surgery.
The 3mm PretzelFlex™ is a strategic line extension to the recently launched 5mm PretzelFlex™ (FDA approval for which was announced in March 2012) and complements the SI 3mm YelloPort+plus™ Access system. The Board looks forward with confidence to the forthcoming US product launch.
Graham Bowland, Chief Executive Officer, commented: "I am delighted we have attained FDA approval for the 3mm PretzelFlex™ device. Such technology allows us to access new areas of MIS and enhances SI's reputation as a leader in innovative organ retraction devices."
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Enquiries:
Surgical Innovations Group plc |
www.sigroupplc.com |
Doug Liversidge, Non-Executive Chairman |
Tel: +44 (0) 113 230 7597 |
Graham Bowland, Chief Executive Officer |
[email protected] |
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Seymour Pierce Limited |
www.seymourpierce.com |
Mark Percy (Corporate Finance) |
Tel: +44 (0) 20 7107 8000 |
David Banks (Corporate Broking) |
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Walbrook PR Ltd |
Tel: +44 (0) 20 7933 8780 |
Paul McManus |
Mob: 07980 541 893 or [email protected] |
Lianne Cawthorne |
Mob: 07584 391 303 or [email protected] |
Notes to Editors:
About Surgical Innovations Group plc
Surgical Innovations Group plc specialises in the design and manufacture of creative solutions for 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.
Over 120 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 distribution partners, Surgical Innovations branded products are sold in major medical markets including North America, Britain, South East Asia, Australasia and the Indian subcontinent. |
OEM and IP |
The Group supplies large medical device companies on an OEM basis, generating both sales and IP royalty fees. Clients include Teleflex Medical, Olympus 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, in situ with minimum disassembly and downtime. |
For more information, see www.sigrouplplc.com
