St. Jude Medical announces FDA clearance and CE Mark approval for EnSite Derexi module

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) clearance, CE Mark approval and the launch of the EnSite Derexi™ module, which provides improved electrophysiology (EP) lab efficiency and workflow by enabling communication between the EnSite™ Velocity™ Cardiac Mapping System and the EP-Workmate™ Recording System.

“The integration of the EnSite Velocity System and the EP-Workmate System is an important first step for St. Jude Medical toward our ultimate goal of creating a fully integrated and networked EP lab”

Debilitating cardiac arrhythmias affect millions of people worldwide, creating the need for diagnostic, mapping and ablative technologies which aid treatment. With the introduction of each new proprietary device in the EP lab, communication between technologies becomes more fragmented. The EnSite Derexi module is designed to streamline access, collection and storage of patient data, advancing the communication between commonly used devices.

The EnSite Derexi module enables procedural data (including relevant images, waveforms and other clinical data) and patient medical history information to be shared between the mapping and recording system to produce a single, synchronized patient record of a procedure. Through this integration, the EnSite Derexi module provides an efficient way to manage consolidated diagnostic information to better assist physicians in developing comprehensive treatment strategies. It also has been designed to increase productivity and reduces the potential for data entry errors by eliminating the need for technicians to input redundant patient data on multiple systems.

"The integration of the EnSite Velocity System and the EP-Workmate System is an important first step for St. Jude Medical toward our ultimate goal of creating a fully integrated and networked EP lab," said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. "Increasing procedural workflow efficiency is an important way to help manage the cost of delivering care, and we look forward to advancing technologies that do so by streamlining productivity and optimizing functionality in the EP lab."

The EnSite Derexi module will be displayed at Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions, at the Colorado Convention Center in Denver, on Thursday, May 13 and Friday, May 14 from 9 a.m. to 5 p.m. and on Saturday, May 15 from 9 a.m. to noon.

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