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November 28th – December 4th

November 28th: St. Jude Medical Announces FDA Approval of Optim Lead Insulation for Cardiac Rhythm Management Therapy

St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of an innovative insulation material for cardiac leads used with pacemakers and implantable cardioverter defibrillators (ICDs). Optim(TM) lead insulation is the first silicone-polyurethane co-polymer material created specifically for cardiac lead use.

The new Optim insulation is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation.

Optim insulation is a new hybrid insulation material, blending the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane. St. Jude Medical is introducing Optim lead insulation on two of its newest leads, the Riata® ST Optim ICD lead and the Tendril® ST Optim pacing lead.

A lead is a thin insulated wire that is placed through the vein as part of a pacemaker or ICD implantation procedure. Its tip is attached to the heart tissue, and its other end connects to the pacemaker. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device.

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.

November 28th: Life Spine Announces FDA Approval of Kinetic(R)

Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to Kinetic®, a revolutionary new internally dynamized anterior cervical plating system.

Michael S. Butler, Life Spine's president, CEO and founder, said Kinetic's flexibility of design will allow surgeons another option when performing cervical spine surgery. "This is a unique product that allows surgeons to accommodate the differing needs of an individual patient's anatomy," Butler said. "The surgeon feedback we've had on this product is tremendous."

Kinetic features 2mm of fully adjustable internal dynamization per level and an ultra slim pre-lordosed profile. The dynamic plates range in sizes from 21mm to 111mm; levels 1-5. It has a unique design that allows for generous screw angulation while providing a large graft window, a feature which competitive products do not have. In addition, the bone screws utilized with Kinetic feature the company's patented Secure-Snap(TM) locking mechanism, which produces an audible and tactile "click" when locked. This unique locking mechanism prevents both screw rotation and backout while still allowing for screw angulation.

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