Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - May 13, 2010

St. Jude Medical Advances Integration of Electrophysiology Lab Equipment with Launch of EnSite Derexi Module

New EnSite Derexi module provides an interface between the EnSite Velocity Cardiac Mapping System and the EP-Workmate Recording System

ST. PAUL, Minn.--(HSMN NewsFeed)--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.

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.

About the EnSite Velocity System and the EP-Workmate System

The EnSite Velocity System is an advanced cardiac mapping system designed to help physicians more efficiently diagnose and guide therapy to treat abnormal heart rhythms. The EnSite Velocity System creates a three-dimensional (3D) model of the patient’s heart, allowing physicians to visualize their patient’s unique anatomy with great detail. Physicians can then quickly locate the source of the arrhythmia and formulate a treatment strategy.

The EP-WorkMate™ Recording System is a highly sophisticated, yet simple to use, system that displays intra-cardiac signals for diagnosis by an electrophysiologist. With its unique real-time information sharing capabilities, the EP-Workmate puts nearly everything needed to complete a study right at the EP’s fingertips. The EP-Workmate Recording System was added to the St. Jude Medical product portfolio through the acquisition of EP MedSystems in the third quarter of 2008.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2010. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

Issuer of this News Release is solely responsible for its content.
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