The PK Papyrus Covered Coronary Stent System (Biotronik) was approved by the US Food and Drug Administration, the agency announced Friday.
The device is the first one in 17 years approved by the FDA to treat acute coronary artery perforations.
“An acute coronary artery perforation is a rare, but potentially life-threatening, complication of heart vessel procedures,” said Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, in the FDA news release. “The PK Papyrus Covered Coronary Stent System provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure.”
Pediatric cardiac arrest survivors initially classified as having favorable outcomes had significant neuropsychological impairments when tested a year later, a prospective evaluation found.
While 71% of survivors in the Therapeutic Hypothermia After Pediatric Cardiac Arrest Out-of-Hospital (THAPCA-OH) and the Therapeutic Hypothermia After Pediatric Cardiac Arrest In-Hospital (THAPCA-IH) clinical trials were rated as having favorable neurobehavioral outcomes by their caregivers, a secondary analysis showed many of these children had performance-based neuropsychological deficits, reported Beth Slomine, PhD, of the Kennedy Krieger Institute, and colleagues in JAMA Neurology.
Updated recommendations for the diagnosis and management of resistant hypertension (RH) have been released by the American Heart Association (AHA) that lower the threshold to 130/80 mm Hg.
The document is the first revision since the AHA's initial 2008 scientific statement on hypertension, noted Robert M. Carey, MD, of the University of Virginia Health Sciences Center in Charlottesville, and colleagues.
Eating dairy daily -- including full-fat products -- was associated with lower risk of death or cardiovascular disease in the large multinational PURE cohort study.
Consumption of more than two servings of dairy versus no intake each day was linked with a lower risk of death or a major cardiovascular event, including death from cardiovascular causes, non-fatal MI, stroke, and heart failure (HR 0.84, 95% CI 0.75-0.94,P=0.0004).
Blood pressure (BP) reductions (relative to usual care) obtained in a 12-month intensive antihypertensive intervention were not maintained in longer-term follow-up, researchers said, suggesting that patients who achieve their BP goals with such regimens must still be managed closely.
Assessments of 326 participants in a cluster-randomized trial -- in which patients were assigned to either intensive monitoring and management or to usual care -- conducted over an additional 42 months showed that the intensive approach's benefits over usual care dissipated after the randomized phase had ended, reported Karen Margolis, MD, MPH, of HealthPartners Institute for Education and Research in Minneapolis, and colleagues in JAMA Network Open.
Nicole Lou, Contributing Writer, MedPage Today
Nicole Lou,Contributing Writer, MedPage Today
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Judy George, Contributing Writer, MedPage TodaySeptember 17, 2018
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The SCOT-HEART Investigators.; NEJM 2018; 379:924-33
Y Qi, et al.; JACC 2018; 72:1201-10
M Valgimigli, et al.; The Lancet 2018; 392:835-48
G Chi, et al.; AHJ 2018; 203:17-24
E Salaun, et al.; Circ 2018; 138:971-85
Nicole Lou, Reporter, MedPage Today/CRTonline.org
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