St. Jude Medical Announces CE Mark Approval of the World’s Only MultiPoint Pacing Pacemaker

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of the Quadra Allure MP^™ cardiac resynchronization therapy pacemaker (CRT-P). The Quadra Allure MP is the world’s first and only quadripolar CRT-P with the MultiPoint Pacing option, a technology that has been shown to enhance patients’ response to CRT, potentially improving quality of life for patients with heart failure. The MultiPoint Pacing technology enables physicians to pace multiple locations on the left side of the heart, giving the clinician more choices to best optimize CRT pacing based on patient need and reducing the rate of CRT non-responders, as well as the likelihood of costly and invasive lead revision through a second intervention procedure.

A recent study demonstrates that MultiPoint Pacing technology may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy, which accounts for approximately one third of the total population of patients receiving cardiac resynchronization therapy (CRT). The technology, developed by St. Jude Medical, has demonstrated a 19 percent improvement in responder rates for patients with MultiPoint Pacing at 12 months compared to traditional methods of CRT. Additionally, research found improvement in left-ventricular (LV) function in patients who were already classified as a responder to CRT therapy.

The Quadra Allure MP CRT-P is designed to work with the Quartet™ LV lead, which has four electrodes to offer maximum flexibility for different pacing configurations to help manage heart failure patients. The MultiPoint Pacing capability allows physicians to program simultaneous or sequential delivery of two LV pulses at two different anatomical locations per pacing cycle, rather than the standard single pacing pulse, which can result in more effective resynchronization, potentially leading to better clinical outcomes compared to single site pacing.

St. Jude Medical developed the quadripolar technology, launching the first ever quadripolar lead in 2011 and entered the pacemaker market in April 2013 with the Allure Quadra™ CRT-P System. Quadripolar technology offers physicians more options to manage heart failure and facilitates additional pacing configurations within the heart that offer physicians options not available in traditional bipolar systems. Earlier this year, the MORE-CRT prospective, randomized clinical trial of more than 1,000 patients demonstrated a 40 percent relative risk reduction of lead-related complications for patients implanted with the Quartet LV lead. To date, more than 100 clinical publications have provided broad clinical evidence supporting the advantages of quadripolar technology from St. Jude Medical.

Today’s announcement follows data that was presented during the XVI International Symposium on Progress in Clinical Pacing in Rome December 2 – 5, 2014. Building upon the 19 percent improved responder rate, data shows that MultiPoint Pacing improved LV function for both responders and non-responders compared to traditional CRT. Additionally, a study suggests that multipoint LV pacing may reduce the burden of premature ventricular contractions (PVC), potentially improving the effectiveness of CRT.

“From our initial experience, we think MultiPoint Pacing improves cardiac function, resulting in better resynchronization and could be a further advantage of CRT,” said study investigator, Dr. Francesco Zanon, MD, FESC, FHRS, director of the Electrophysiology Unit Department of Cardiology from Santa Maria della Misericordia Hospital in Rovigo, Italy. “We observed significant improvement over traditional CRT pacing, and therefore believe this technology could have wide application because it is accessible for all CRT implanters.”

“The St. Jude Medical quadripolar pacing system has been successfully designed for optimized outcomes, now adding MultiPoint Pacing as an additional set of tools designed to decrease the rate of non-responders and improve clinical outcomes even in difficult to treat patients with ischemic heart disease,” said Eric S. Fain, M.D., group president of St. Jude Medical. “Building upon the industry’s first quadripolar platform, the MultiPoint Pacing technology is an excellent example of our continued commitment to investing in innovative solutions that reduce health care costs and improve outcomes for patients.”

MultiPoint Pacing is an investigational device and is not commercially available in the U.S.

Quadripolar Pacing Technology from St. Jude Medical

St. Jude Medical introduced the industry’s quadripolar pacing system featuring four pacing electrodes. The quadripolar pacing system offers physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The system integrates multiple pacing configurations and Tailored Therapy^™ 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 Quartet lead design allows 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 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.

About St. Jude Medical’s Heart Failure Business

St. Jude Medical’s introduction of the Quadra Allure MP™ CRT-P expands the suite of heart failure intervention products designed to support the care of approximately 26 million people worldwide who suffer from heart failure. This technology portfolio includes the CardioMEMS^™ HF Monitoring System, implantable cardioverter defibrillators (ICD), quadripolar and multi-point pacing systems.

St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to develop these innovative, cost-effective solutions for heart failure patients around the world. For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

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 Annual Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

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