St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP ™ cardiac resynchronization therapy defibrillator (CRT-D). Built upon the company’s first-to-market Quadripolar Pacing System, the Quadra Assura MP CRT-D features MultiPoint ™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy (CRT) pacing to meet individual patient needs.
Preliminary results from a study presented at this year’s Heart Rhythm Society (HRS) Scientific Sessions showed that after three months, 89 percent of patients treated with the St. Jude Medical MPP were classified as responders, an increase of nearly 20 percent. On average, the response rate to traditional CRT is approximately 70 percent.More than 80 publications provide broad clinical evidence for the advantages of the St Jude Medical quadripolar technology. A number of additional studies are underway to support that MPP may provide improvements in cardiac function and hemodynamics. St. Jude Medical is currently conducting a pivotal U.S. clinical study, under an Investigational Device Exemption (IDE), on the MultiPoint™ CRT pacing feature. The study is evaluating outcome benefits such as improved hemodynamics (blood flow) and cardiac function in heart failure patients who receive CRT. Additionally, a single-center, research study will compare six month efficacy of CRT with MPP at various programmed parameters. The results from these studies will strengthen the clinical evidence for MPP. Additionally, starting later this year, a European post-market study will further evaluate the efficacy of MPP therapy in patients not responding to traditional CRT. EHRA EUROPACE 2013 attendees can visit St. Jude Medical at Booth # H3-A400 to see the new MPP technology. Quadra Assura MP ™ CRT-D is an investigational device in the U.S and is not commercially approved in the U.S. 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 Annual Report on Form 10-K for the fiscal year ended December 29, 2012 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 30, 2013. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.