Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - June 22, 2007

St. Jude Medical Announces CE Mark Approval of OptiSense Pacing Lead

New Lead Clinically Proven to Improve Implantable Device Therapy; Trial Results to be Presented at Europace 2007 in Lisbon

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced CE Mark approval of its new OptiSense(TM) lead, a first-of-its-kind pacing lead designed to offer more accurate sensing in the upper chamber of the heart (right atrium). The lead, which will be introduced at the Europace 2007 Meeting in Lisbon, Portugal, incorporates a new tip design that increases the device's ability to detect and classify electrical signals in the atrium more accurately by avoiding picking up signals from the heart's lower chambers (ventricles). This improves the pacemaker's response to sensed signals and the accuracy of device diagnostic reports.

This improved device therapy has now been demonstrated in two completed clinical trials. The results from the International OptiSense Lead Clinical Study will be presented on June 24, at Europace 2007 by Johannes Sperzel, M.D., of the Kerckhoff-Klinik in Bad Nauheim, Germany. (Results from the U.S. OptiSense Lead Clinical IDE (investigational device exemption) Study were presented in May at the Heart Rhythm Society's Scientific Sessions in Denver, Colo.)

Because the design of the OptiSense lead allows for more accurate detection of impulses from the patient's atrium, the new lead offers physicians more flexibility in programming the device's atrial sensitivity settings while avoiding the sensing of signals from the ventricles. 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.

By reducing the detection of unwanted signals, the OptiSense lead also may give physicians greater freedom in lead placement options. With the OptiSense lead, physicians may be able to place leads lower in the atrium - a potentially optimal location for pacing that previously created challenges because of interfering signals from the heart's lower chambers.

"Accurate atrial sensing is especially important when using pacemaker therapy for patients with atrial tachyarrhythmia," said Dr. Sperzel. "In clinical studies of the OptiSense lead, we had greater freedom in lead placement and were able to use higher atrial sensitivity settings to more readily detect even very fine atrial signals."

The improved sensing performance of the OptiSense lead is a result of compressed spacing between the lead's tip and ring. The 1.1 mm tip-to-ring spacing 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). Conclusions from the U.S. OptiSense Lead Clinical IDE Study showed:

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 lead 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. In addition to the OptiSense lead, St. Jude Medical also will debut its newest pacemakers--the Zephyr(TM) family of devices--at Europace 2007. The Zephyr pacemaker is designed to save valuable clinic time by automatically performing all standard follow-up testing before the patient arrives in the clinic. When a Zephyr device is interrogated during a follow-up visit, the stored diagnostics, trends and measurements from the automatic tests are displayed for evaluation. Physicians can validate each test by viewing the associated stored electrograms. The Zephyr device also is the first pacemaker that can, in about 90 seconds, tell physicians which device timing settings are optimal for each patient's needs, via the company's QuickOpt(TM) Timing Cycle Optimization feature.

"The enhanced sensing capability of the OptiSense lead promotes pacing that more closely mimics the natural workings of the heart," said Joseph H. McCullough, president of St. Jude Medical's International Division. "Both the OptiSense lead and Zephyr pacemaker represent St. Jude Medical's commitment to providing physicians with innovative systems that provide optimal therapy for their patients."

The OptiSense Lead Clinical Study results will be presented by Dr. Sperzel at Europace 2007 on June 24 at 15:45 in the Guarda Meeting Room of the Lisbon Congress Centre.

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 pages 13-20) and Quarterly Report on Form 10-Q filed on May 9, 2007 (see pages 23-24). The Company does not intend to update these statements.


Source: St. Jude Medical

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