“The analysis of the data from patients in the per-protocol group and the as-treated group provide compelling evidence that PFO closure with the AMPLATZER PFO Occluder is superior to medical management from both clinical and statistical perspectives,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “The totality of evidence from this study, including the strong performance and safety profile of the device, demonstrates the compelling clinical benefits of closure versus medical management in reducing the likelihood of recurrent stroke in this patient population.”
According to the World Health Organization (WHO) an estimated 15 million people worldwide suffer from stroke each year. Of these, 5 million die and another 5 million are left permanently disabled, placing a burden on families and communities. It is estimated that 87 percent of all strokes are ischemic strokes, which occur when blood clots block the blood vessels to the brain. Up to 40 percent of ischemic strokes are classified as cryptogenic, which means the cause of the stroke is unknown.
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. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.