FDA Clears St. Jude’s ACross Transseptal Access System

 

July 26, 2007

July 26, 2007 - St. Jude Medical Inc. announced that the U.S. FDA cleared the ACross Transseptal Access System, a device designed to improve control and simplify the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation ablation, in addition to receiving a Health Canada License.

The device, engineered to enable access to the left atrium of the heart, consolidates the sheath, dilator and needle into a single interlocking handle for greater control over the system’s components and more intuitive positioning within the heart. The device’s handle allows the components to fit precisely together, ensuring that the puncture needle is not deployed until the physician is confident in its location, and that it is only advanced a pre-determined distance. Also, the ergonomic design incorporates a directional fin, or ridge, on the handle, designed for the physician to intuitively know the orientation of the needle and sheath tip within the heart.

For more information: www.sjm.com