St. Jude Medical Receives FDA Approval to Resume U.S. Evaluation of the Portico System

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the resumption of the company’s U.S. IDE trial evaluating the Portico™ Transcatheter Aortic Valve Implantation System. The Portico IDE trial originally launched in May 2014, and is designed to support U.S. approval of the Portico system.

The approval follows a comprehensive review of the Portico system by the U.S. Food and Drug Administration (FDA) after St. Jude Medical temporarily paused implants of the valve worldwide in September 2014. The company decided to pause implants due to reports of reduced leaflet motion observations in patients implanted with Portico within the IDE study. The observation was subsequently identified in the study’s control arm, which consisted of commercially-available TAVR valves.

St. Jude Medical’s review found no excess rate of clinical events associated with the leaflet motion observation. The company’s findings were then confirmed by independent reviews, which found reduced leaflet mobility is a class effect, present in TAVR and surgical valves across the industry. The data also confirmed that the observation is not linked to excess adverse clinical events, has not been shown to impact valve clinical performance and can be resolved by medical therapy.

“We are excited to resume our U.S. IDE trial, which is a critical step toward providing the Portico valve to more patients in need,” said Dr. Mark Carlson, chief medical officer for St. Jude Medical. “We have been encouraged by the clinical results and the response of physicians to the Portico valve in Europe and other geographies. We look forward to continuing to partner with physicians in the U.S. to further evaluate the benefits of the Portico system.”

Aortic stenosis is the third most prevalent form of cardiovascular disease in the Western world after hypertension and coronary artery disease. Considered a potentially life-threatening condition, in patients suffering from severe aortic stenosis the aortic heart valve becomes calcified and does not open properly. TAVR procedures offer physicians an additional treatment option for patients who are considered too high of a risk to undergo open heart surgery.

The Portico system was developed to simplify TAVR procedures for physicians by improving control, ease of use and accuracy over other commercially-available TAVR valves. The system also offers the ability to be fully recaptured and repositioned prior to full deployment and release from the delivery system, allowing physicians to obtain optimal placement to improve patient outcomes.

“I’m very proud to work alongside a team of investigators that partnered with St. Jude Medical to prioritize patient safety and support the industry’s current understanding of leaflet motion observations relative to transcatheter and surgical valves,” said Dr. Raj Makkar, director of interventional cardiology at Cedars-Sinai Heart Institute in Los Angeles and a co-principal investigator for the Portico U.S. IDE. “I’m excited to be able to resume our IDE study and advance the evaluation of the Portico valve in the U.S.”

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 January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2015. 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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Contact information

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
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Justin Paquette, 651-756-6293
Public Relations
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