In short
UK device maker Surgical Innovations Ltd (SI) has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Reusable PretzelFlex™ device, permitting the use of PretzelFlex™ in the US market for organ and tissue retraction.
Background
So named because of its shape, the PretzelFlex™ device is easily inserted through a 5mm laparoscopic port and when deployed, adopts its unique “Pretzel” configuration which has been designed to act as an organ retractor. The device works by way of patented “segment technology” and according to the manufacturer is noted for its strength and stability , which makes it a particularly useful tool with which to support larger organs, especially in minimally invasive obesity surgery.
Surgical Innovations exhibited PretzelFlex™ at the recent Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) congress in San Diego, where it claims the product attracted significant interest from attending US surgeons.
SI made a lasting impression on delegates by shipping out a giant sized pretzel shaped ‘Scalextric’ track to help promote PretzelFlex™.
Company comments
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.”
“We had an incredible show and it was a real honour to be the only British company at the Congress.”
“In a market that is dominated by expensive throw-away devices our Resposable™ instruments were seen as a ‘breath of fresh air’ by both surgeons and procurement managers alike.”
“Using our instruments surgeons can still enjoy high quality instrumentation but also save their hospitals hundreds of pounds per procedure. This concept really triggered a nerve with US surgeons and they are excited about the technologies that we have to offer.”
Source: Surgical Innovations
published: March 23, 2012 in: Approval/Clearance, General Surgery, Gynaecology/Obstetrics, Regulatory