Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - May 9, 2007

St. Jude Medical Announces FDA Approval of the OptiSense(TM) Pacing Lead

New lead allows for more sensitive sensing of signals from the upper chamber of the heart

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of its new OptiSense(TM) lead, a first-of-its-kind "smart" pacing lead designed to offer more accurate sensing in the upper chamber of the heart (right atrium). The lead incorporates a new tip design that reduces extraneous signals from the heart's lower chambers (ventricles) that can interfere with a pacemaker's sensing mechanism and disrupt optimal therapy.

The OptiSense lead's improved sensing of desired electrical signals in the atria allows physicians more flexibility in programming atrial sensitivity settings while avoiding sensing signals from the ventricles. This allows for more accurate detection of impulses from the patient's atrium. In the past, physicians sometimes had to program a pacemaker to be less sensitive to avoid the detection of interfering signals. However, while decreasing the sensitivity settings helps to reduce the interfering signals, it can also reduce the sensing of important signals, like the small signals that can occur during atrial arrhythmias.

More sensitive atrial sensitivity settings are, therefore, especially important in patients with atrial tachyarrythmias (an abnormally fast heart rate), such as atrial fibrillation.

By reducing the detection of unwanted signals, the OptiSense lead may also provide physicians greater freedom in lead placement options. Now, leads may be able to be placed in areas, such as the lower inner atrium, that may be optimal for pacing, but that may have previously been ruled out because of interfering signals from the heart's lower chambers.

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

The improved sensing performance of the OptiSense lead is a result of an innovative 1.1 mm tip-to-ring spacing, which reduces oversensing of far-field R-wave signals (an electrical signal originating in the lower chamber of the heart and sensed by the lead in the upper chamber of the heart). The conclusions reached by the OptiSense Lead Clinical Study (the results of which will be presented on May 9 at 5:45 p.m. Mountain time during the Featured Poster Session at the Heart Rhythm 2007 meeting) include the following:
  • The OptiSense lead had no evidence of paced far-field signals in 90.9 percent of patients compared to 40.9 percent of the control patients (p less than 0.0001).
  • The OptiSense lead group exhibited a highly statistically significant reduction (p = 0.03) in the percentage of patients with inappropriate mode switching (6.9 percent of OptiSense patients versus 25.7 percent of control group patients) as well as a highly statistically significant reduction (p = 0.009) in the percentage of episodes of inappropriate mode switching (3 percent versus 49 percent). Inappropriate mode switching is not desirable because, if it occurs, it can cause a loss of synchrony between the upper and lower chambers of the heart.
"The innovative design of the OptiSense lead offers significant advantages for both physicians and patients," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "These new features enhance pacemaker function, support physician preferences to pace more physiologically and provide better therapies for patients."

Heart Rhythm 2007 is the most comprehensive educational program for heart rhythm professionals, featuring over 200 educational sections and more than 130 innovative products and services. This year, the meeting will open with the AFib Summit, a two-day intensive summit on atrial fibrillation featuring world-renowned experts. The Heart Rhythm Society's Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

About St. Jude Medical

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. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 11,000 people worldwide. For more information, please visit www.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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). 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

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