We think of UK MIS device company Surgical Innovations Group plc, as a “one to watch” and as such find ourselves writing about it from time to time. Now it has announced that it has shipped the first batch of PretzelFlex® devices under the distribution agreement with CareFusion we announced here a few months back. A second batch is planned for December, suggesting the group is bullish about its prospects.
PretzelFlex® has been developed by Surgical Innovations for the effective elevation or retraction of organs and tissue during MIS procedures to provide better access as well as visualisation of surgical sites. The device has a slim line shaft that can be inserted through a 5mm port access system. Then, once inside the abdomen it forms into the innovative pretzel shape when deployed by the surgeon. The device was granted 510(k) clearance from the US FDA in March 2012.
In June, SI announced an eight-year distribution agreement with CareFusion, a leading, global medical device company, giving it exclusive rights to sell PretzelFlex® in the US. The device will be marketed in the US under the CareFusion brand and SI will retain the right to manufacture and distribute the device under the SI brand in all other markets.
Graham Bowland, Chief Executive Officer, commented: “We are extremely pleased to announce the first shipment of the PretzelFlex® device in accordance with agreed delivery dates. The American College of Surgeons congress in Chicago was a great success with substantial interest in the device from attending surgeons of all nationalities. With our distribution agreement with CareFusion, we are confident that this product will be the retractor of choice with US surgeons.”
Source: Surgical Innovations Group, plc