“Confirmation of this latest agreement with CareFusion affirms a long standing and successful partnership and gives us increased exposure to a growing US market for innovative MIS products”
Minimally invasive surgery(MIS) device maker Surgical Innovations Group plc (SI), and healthcare company CareFusion Inc. have agreed an eight year exclusive US distribution agreement for SI’s clever PretzelFlex® laparoscopic retractor.
At medlatest we’ve covered PretzelFlex® before, most recently with the news that the device had gained FDA 510(k) clearance for sale in the United States, here.
SI developed and patented PretzelFlex® as an effective means of retraction or repositioning of large organs, such as the liver, to provide proper access and visualisation during complex MIS procedures. The device is already popular in the retraction of the liver during a gastric bypass for which type of operation the liver must be moved in order to obtain access to the upper stomach. The PretzelFlex®, designed for MIS insertion, forms a robust makes it much easier for doctors to retract large or swollen livers that are common in obese individuals.
Under the terms of the agreement, the device will be manufactured by SI and marketed in the U.S. under the CareFusion brand. CareFusion has acquired exclusive US rights to PretzelFlex® for eight years. This replaces the existing licensing agreement for the Diamond-Flex® which is due to end in 2012 and is based on minimum contracted volumes.
Outside U.S, SI retains the right to manufacture and distribute the device under the SI brand in all other markets, with an SI branded PretzelFlex® already successfully launched in Europe.
PretzelFlex® generated significant interest from US surgeons at the recent SAGES congress (Society of American Gastrointestinal and Endoscopic Surgeons) in San Diego, and having received FDA 510(k) clearance in March 2012 SI is clearly pleased to have secured this deal which ensures continuous revenue streams in an already established market.
Graham Bowland, Chief Executive Officer of SI, said: “Confirmation of this latest agreement with CareFusion affirms a long standing and successful partnership and gives us increased exposure to a growing US market for innovative MIS products.”
Source: Surgical Innovations PLC