ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of its Ellipse™ implantable cardioverter defibrillator (ICD). Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD offers physicians unique design advancements, resulting in the industry’s smallest high-energy ICD.
The Ellipse ICD’s unique shape was conceptualized by physicians during focus groups where they crafted in clay their vision for the ideal device design. The physician-inspired shape is unlike any device currently available and designed to increase patient comfort and physician ease-of-use. The angled header and rounded edges were designed to improve the way a lead wraps around the device once connected, which can result in a smaller incision and reduced pocket size for the device.
“The St. Jude Medical Ellipse ICD not only will streamline the implant procedure and improve patient comfort with its innovative design, but the device adds safety features with its new discrimination algorithms intended to minimize inappropriate shocks,” said Rahul N. Doshi, M.D., at Fullerton Cardiovascular Medical Group, Inc., in Fullerton, Calif.
The Ellipse ICD features SecureSense™ RV Lead Noise Discrimination, an algorithm that expands St. Jude Medical ShockGuard® Technology, differentiating lead noise (over-sensing of electrical signals) from true ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes requiring therapy. The technology is expected to assist physicians by more proactively lowering the risk of lead-related complications through its ability to automatically withhold tachycardia therapy in the presence of lead noise.
The Ellipse ICD provides all of the industry-leading features offered by the Fortify Assura™ ICD inside the smallest volume, high-voltage device on the market. The Ellipse ICD allows for 36 J in delivered energy, providing a downsized option without compromising on energy, longevity, safety or reliability. Similar to the Fortify Assura ICD, the Ellipse ICD adheres to the International Standards Organization (ISO) DF4 connector specification. The DF4 connector reduces the number of connections between the defibrillation lead and the device. St. Jude Medical was the first manufacturer to offer DF4 technology in early 2009.
“We feel collaboration with physicians in regards to the planning and design of our devices is imperative in order to develop truly breakthrough technologies,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “With the launch of the Ellipse ICD and the Assura family of implantable defibrillators, St. Jude Medical is able to provide physicians with a complete portfolio of devices that meet the individualized needs of patients, and our customers’ needs for reliable, efficient technologies.”
The St. Jude Medical high-voltage portfolio is augmented by the Durata™ defibrillation lead. With more than 10,000 leads actively monitored in prospective active registries and more than 27,000 patient years of data, the Durata lead continues to demonstrate excellent performance by any measure.
ICDs are advanced implantable devices that treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardia or ventricular fibrillation) that often lead to sudden cardiac death (SCD).
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 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012. 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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