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  • Regulatory NewsRegulatory News

    Edwards Recalls Part of Transcatheter Heart System After One Death

    Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday. FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may caus...
  • Regulatory NewsRegulatory News

    FDA Used Real-World Evidence in Heart Valve Approval

    The US Food and Drug Administration (FDA) says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement (TAVR) to valve-in-valve procedures. In a blog post Wednesday, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren and Bram Zuckerman, director of CDRH's Division of Cardiovascular Devices touted the agency's turnaround from 42nd in the world to approve a TAVR devic...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    • By
    The Centers for Disease Control and Prevention (CDC) would be tasked with compiling, analyzing and publishing data on drug overdoses if a new piece of proposed legislation is signed into law. The bill, the Stop Overdose Stat Act (S.O.S. Act) , is more broadly intended to reduce the number of drug overdoses occurring in the US. The bill notes more than 36,000 Americans died from drug overdoses in 2008, with approximately three-in-four of these deaths resulting from a...
  • FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve

    Review staff from the US Food and Drug Administration (FDA) said Edwards Lifesciences' Sapien Transcatheter Heart Valve (THV) met trial endpoints for safety and effectiveness for the treatment of high-risk severe aortic stenosis, but expressed concern about trial biases, long-term risks to patients and the statistical validity of some of Edwards' findings. Edwards' device is set to go before a meeting of the Circulatory Systems Advisory Committee on 13 June, where Edward...
  • CMS Coverage Decision Based on FDA Parallel Review Program

    A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an October 2011 memorandum of understanding with the US Food and Drug Administration (FDA). "This decision is particularly important as it highlights cooperative efforts among CMS, FDA, the Agency for Healthcare Research and Quality, medical specialty societies and the medica...