Healthcare Industry News: PFO Occluder
News Release - January 3, 2012
St. Jude Medical Announces Achievement of Stopping Rule and Closing of Patient Enrollment in RESPECT Clinical TrialEight-year trial examines the safety and efficacy of PFO closure for stroke
ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced that it has met a stopping rule in its RESPECT clinical trial – triggered by reaching the protocol-required number of primary events in the trial, defined as stroke and all-cause mortality – and is closing patient enrollment.
“With more than eight years of patient investigation and follow up that includes enrolling 980 patients and collecting more than 2,300 patient-years of data, we’re thrilled to announce that we have achieved a significant milestone in our RESPECT trial,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “We’re confident in the robust design of our clinical study and in our differentiated product design. We are currently focused on analyzing data from the trial and anticipate presenting results at a major medical meeting sometime in 2012.”
The RESPECT trial is a randomized, multi-center study investigating whether closure of the Patent Foramen Ovale (PFO), a congenital heart defect, using the St. Jude Medical AMPLATZER® PFO Occluder device, is safe and effective compared to current standard-of-care treatment in the prevention of a cryptogenic stroke. A cryptogenic stroke is one for which the origin or cause of stroke is unknown.
The RESPECT trial is an event-driven, adaptive design that utilized defined outcome events to determine sample size via a series of stopping rules. This design allows the trial to continue until sufficient events have accumulated to be able to assess treatment effectiveness. The study design also means that by protocol, patients enrolled in the trial will continue to be followed until regulatory approval is granted by the U.S. Food and Drug Administration (FDA), thus providing substantial long-term follow-up on this patient population.
A PFO is one potential suspected cause of cryptogenic stroke. The foramen ovale is a flap or tunnel-shaped hole in the atrial septum, the wall that divides the upper two chambers of the heart, which forms during fetal development to allow blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. A PFO results if this opening does not completely close shortly after birth, and can allow a blood clot from one part of the body to travel through the flap and up to the brain, causing a stroke.
For more information on the clinical trial and the warning signs of stroke, visit www.respectstudy.com.
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.
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 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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