St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the European launch of the Unify Quadra(TM) cardiac resynchronization therapy defibrillator (CRT-D). The Unify Quadra CRT-D works with the company’s Quartet(TM) left ventricular pacing lead. The combined system offers physicians the ability to effectively and efficiently manage the changing pacing needs of patients with heart failure with a downsized quadripolar pacing system. In Europe, heart failure affects more than 14 million people and is projected to affect about 30 million by 2020.
St. Jude Medical introduced quadripolar technology last year in Europe with the Promote Quadra(TM) CRT-D, and is the only company to offer quadripolar technology. The system integrates multiple pacing configurations and features that enable physicians to optimise the system at implant and throughout the life of the patient, as well as better manage common pacing complications without exposing the patient to additional surgeries to reposition the lead.
The Unify Quadra is the next generation of the technology, providing all the benefits of quadripolar technology in a device with the industry’s smallest footprint. The device’s narrower shape allows physicians to implant the system using a shorter incision, with less time spent closing the incision, and a smaller scar for the patient.
The Unify Quadra uses the new International Standards Organization (ISO) DF4 and IS4 connector specifications to further streamline the procedure. The DF4 connector reduces the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest. The IS4 connector enables four electrodes to be used on the Quartet left ventricular pacing lead while connecting to a single standard connector on the Unify Quadra device.
The Quartet left ventricular pacing lead – used as part of the Unify Quadra system – features four electrodes, instead of the usual two. Multiple pacing configurations allow the physician more options, including pacing closer to the base of the left ventricle, which recent studies associate with better patient outcomes and which may be less possible with traditional leads that only have two electrodes. The quadripolar pacing electrodes also provide physicians additional benefits, such as pacing around scar tissue in the heart and avoiding the most common pacing complications.
Commenting on the technology, Dr. Amir Zaidi, consultant cardiologist at the Central Manchester University Hospitals NHS Foundation Trust, said, “Diaphragmatic stimulation is the most common implant-related problem that prevents my patients from receiving effective cardiac resynchronization therapy. Unify Quadra is my “go to” technology in these cases and I believe its benefits can make it the standard of care for cardiac resynchronization. With quadripolar technology, I can deliver effective treatment to patients who would otherwise be denied gold-standard therapy for heart failure using conventional CRT devices.”
Because the physician can non-invasively adjust pacing locations or configurations, the technology has the potential to reduce patients’ risk of needing multiple surgeries. This is important because some complications, such as phrenic nerve or diaphragmatic stimulation are body-position sensitive and may not be evident while patients are lying on their back during the implantation procedure. More than thirty publications provide clinical evidence supporting the benefits of the quadripolar technology in managing common pacing complications, enabling better clinical efficiency, and providing a greater opportunity for efficacy.
“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 evidence, positive 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.”
In heart failure patients, the heart often beats out of sync. Cardiac resynchronization therapy resynchronizes the beating of the heart by pacing both lower chambers (ventricles) rather than just one (the right ventricle). 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. Currently, heart failure results in more than 3.6 million hospitalizations per year in Europe, and related costs represent approximately 2 percent of overall health care expenditures.
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.