“The overall trial demonstrates that PFO closure with the AMPLATZER PFO Occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.About PFO and the RESPECT Trial Normal in a developing fetus, the foramen ovale allows oxygenated blood from the placenta to bypass the lungs. This small, flap-like opening typically closes shortly after birth. When the flap remains open, or patent, it is referred to as a PFO. A PFO can potentially allow dangerous clots to pass from the right side of the heart to the left, travel up to the brain and cause a stroke. Visit the St. Jude Medical PFO and Stroke Answers website for more information. The RESPECT clinical trial was a prospective, randomized (1:1), event driven-study designed to determine if PFO closure with the AMPLATZER PFO Occluder plus medical management was superior over medical management alone in the prevention of recurrent cryptogenic (unknown cause) stroke. The study enrolled 980 patients across 69 centers in the U.S. and Canada. Enrollment in the trial stopped once 25 primary events occurred, all of which were recurrent, non-fatal strokes. Of the 25 strokes, nine were in patients randomized to the device group. It’s important to note that three of the nine strokes in the device group occurred in patients who didn’t have a device in place. Prior to participating in the trial, all patients, ages 18 – 60 (average age was 46 years), suffered a stroke confirmed by MRI imaging, which was ruled cryptogenic. Participants were randomly assigned to one of two groups. One group received the AMPLATZER PFO Occluder and medical management, and the other group was treated using the current medical management standard of care alone, which consists of receiving medicine to prevent clots and potentially decrease the risk of another stroke. Patients enrolled in the trial will continue to be followed until a regulatory decision is made by the U.S. Food and Drug Administration (FDA).
The primary efficacy endpoint in the RESPECT trial was defined as a composite rate of non-fatal stroke, post-randomization (<45 days) death or fatal ischemic stroke. Four protocol-specified analyses were applied to the primary efficacy endpoint data to statistically test whether device treatment was superior to medical management.The trial’s original primary endpoint was a 75 percent reduction in the risk of recurrent ischemic stroke in the Intent-To-Treat (ITT) population driven by a raw count distribution of stroke events between the device and medical groups. This was determined to be invalid because of a difference in the number of patients lost to follow-up in each arm of the trial. Of the three valid protocol-specified analyses, the Intent-to-Treat Kaplan-Meier analysis demonstrated risk reduction that did not reach statistical significance, while the other two analyses (Per-Protocol and As-Treated) demonstrated clinically impactful and statistically significant benefits of PFO closure compared to medical management. 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 www.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 September 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.