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|St. Jude Medical Announces FDA Approval of Industry's First Quadripolar Pacing System|
ST. PAUL, Minn., Nov 29, 2011 (BUSINESS WIRE) --
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Unify Quadra(R) cardiac resynchronization therapy defibrillator (CRT-D) and Quartet(R) Left Ventricular Quadripolar Pacing Lead. The company will begin shipping the products to its sales force to begin providing to customers immediately.
As the industry's first quadripolar pacing system, the Unify Quadra CRT-D and Quartet lead offer physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The system integrates multiple pacing configurations and TailoredTherapy(TM) features that enable physicians to optimize the system at implant and follow-up, as well as better manage common pacing complications without having to surgically reposition the lead. The system is also approved for remote patient management utilizing the Merlin.net(R) Patient Care Network.
The Quartet lead - used as part of the Unify Quadra system - features four electrodes spaced over 4.7 centimeters, enabling up to 10 pacing configurations. Multiple pacing configurations allow the physician to implant the lead in the most stable position without making trade-offs in electrical performance. This includes pacing closer to the base of the left ventricle, which recent studies associate with better patient outcomes and which may be more difficult with traditional bipolar leads. The quadripolar pacing electrodes also provide physicians more options to optimize CRT performance, such as pacing around scar tissue in the heart and avoiding the most common pacing complications. The many benefits conferred from the Quartet lead's unconventional pacing have been demonstrated by implanters around the world and reported in a number of published studies.
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 requiring patients to have more surgeries to replace devices 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 patients to hiccup with the delivery of the pacing stimuli. In particular, phrenic nerve and diaphragmatic stimulation may be body-position sensitive and not 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 with limited pacing options, may require that the lead be repositioned surgically or CRT be disabled.
"The Unify Quadra system allows me to deliver effective CRT therapy by programming different lead configurations rather than surgically repositioning the lead itself," said Dr. Charles Gornick, of the Minneapolis Heart Institute at Abbott Northwestern Hospital, a premier cardiovascular facility and the flagship center of the Allina healthcare system in Minneapolis. "This new technology makes it possible to further tailor CRT therapy by being able to select different pacing vectors and adds to my potential options for treating patients who do not respond to CRT therapy."
The Quartet pacing lead is built on the proven QuickFlex(R) u lead platform, featuring Optim(R) insulation. Optim is designed to combine the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, to provide increased durability. The lead's "S-curve" fixation mechanism delivers exceptional stability.
"In addition to not needing to compromise between lead stability and electrical performance when placing the lead, the Quartet lead demonstrates excellent handling characteristics that make the implant procedure more efficient," said Dr. Gery Tomassoni, of Lexington Cardiology at Central Baptist Hospital in Lexington, Ky.
"This new system is designed to manage the dynamic challenges of heart failure," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "Based on the clinical experiences and publications to date, this innovative CRT system has the potential to redefine the standard of care in resynchronization therapy for heart failure patients around the world."
Cardiac resynchronization therapy, which can be delivered by an implantable cardioverter defibrillator (ICD), 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.
For more information visit SJMquadripolar.com.
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.
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 Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2011. 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, Inc.
St. Jude Medical, Inc.