Healthcare Industry News:  neuromodulation 

Devices Cardiology

 News Release - May 11, 2010

St. Jude Medical Announces European Launch of Industry's First Quadripolar Pacing System

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced the European launch of its Promote Quadra™ cardiac resynchronization therapy defibrillator (CRT-D). The Promote Quadra CRT-D is the industry’s first quadripolar pacing system, which offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure. It integrates multiple pacing configurations and features that enable physicians to optimize the system at implant and follow-up, as well as better manage common complications without having to surgically reposition the lead.

The Quartet™ left ventricular pacing lead, used as part of the Promote Quadra system, features four pacing electrodes on the left ventricular lead – enabling up to 10 pacing configurations. Multiple pacing configurations allow the physician to implant the lead in the most stable position, while still being able to select the most optimal pacing location. Having multiple pacing electrodes also provides physicians more options to optimize CRT performance, such as pacing around scar tissue in the heart, and avoiding common pacing complications.

“The Promote Quadra CRT-D gives me a greater number of less-invasive methods for managing my heart failure patients using CRT and reduces my patients’ risk of needing multiple surgical procedures. The Quartet lead also allows me more options for placing the pacing lead, without any compromises on handling characteristics,” said Dr. Wolfgang Kranig of Schüchtermann-Schiller´sche Kliniken in Bad Rothenfelde, Germany. “Because of the benefits this quadripolar technology offers without any significant tradeoffs, it should be considered a new standard of care for CRT.”

Common pacing complications that can occur in patients implanted with a CRT system include high pacing thresholds and unintentional phrenic nerve or diaphragmatic stimulation. Patients with high pacing thresholds require significantly higher energy to pace the heart; this may reduce the device’s battery life or cause pacing to be ineffective. Phrenic nerve and diaphragmatic stimulation occur when the electrical output from a device inadvertently activates the diaphragm muscle (either directly or via the phrenic nerve), causing hiccups upon each pacing stimulus. In particular, phrenic nerve and diaphragmatic stimulation may be body position sensitive and not be evident at the time of the implantation procedure while the patient is lying on their back. Both high pacing thresholds and phrenic nerve or diaphragmatic stimulation are often due to the location of the pacing lead electrode and up until now, have often required that the lead be repositioned surgically.

In addition to multiple pacing options, the Quartet pacing lead features other St. Jude Medical technologies such as Optim™ insulation – a material that combines the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, to provide increased durability, flexibility and improved handling characteristics – and the “S-curve” design of the QuickFlex™ lead family, which increases stability.

“The launch of our Promote Quadra system means that physicians no longer need to make a trade-off between positioning the lead in the most stable location and positioning the electrodes in the best pacing location. It also gives physicians more control over patient therapy by providing the flexibility to non-invasively adjust the pacing location or configuration to meet patient needs,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “This launch of the industry’s first quadripolar pacing system is representative of our strong pipeline of technologies that address the most important clinical needs of patients with heart failure.”

Cardiac resynchronization therapy, which can be delivered by an implantable cardioverter defibrillator (ICD) or a pacemaker, resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Approximately 23 million people worldwide are afflicted with congestive heart failure (CHF), and 2 million new cases of CHF are diagnosed each year worldwide.

The Promote Quadra CRT-D and Quartet pacing lead have both received European CE Mark approval, and are also currently under an investigational device exemption (IDE) trial for United States Food and Drug Administration (FDA) approval.

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

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