FDA Approval for Logic™ reusable instrument range

Wednesday, 6 June, 2012

Surgical Innovations (SI) is pleased to announce that it is has received 510(k) clearance from the US Food and Drug Administration for its Logic™ range of reusable instruments and permits the use of the range in the US market.

 

The instruments are compatible with SI's Logic™ Handles, which already have approval in the US, and are currently used with SI’s Resposable™ Logi™Range.

 

Graham Bowland, Chief Executive Officer at SI, said: “We are delighted to announce the FDA approval of our reusable instruments in the US.  The economic drivers away from single use instruments in the US are clear, and our modular instruments are ideally positioned to satisfy current surgical procedure budgets.”

 

We are also pleased to announce that our  US master dealer, SI USA,  has been awarded a contract by the Premier healthcare alliance for the sale of our Resposable™ Logi™Range, and Logic™ range of reusable instruments.  The contract will run from 1 April 2012 for three years, with the option to extend a further two years upon the agreement of both parties. 

 

The contract will provide SI with additional access to hospitals and hospital networks across the US, and replaces previous, but more limited, contracts already held with Premier. 

 

Graham Bowland continued: “This latest contract with Premier provides us with much more flexibility in the products we can offer whilst giving us access to hospitals that we were previously unable to approach.  This is a very exciting development and strengthens our position in our largest target market.”