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For the past year drug-eluting stents (DES) have raised concerns about blood clots, damaging sales of FDA-approved DES devices.
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Accuray (Sunnyvale, California), a developer of radiosurgery products, has entered into an agreement with CyberHeart (Menlo Park, California) to use Accuray's technology to develop a non-invasive method for performing cardiac ablation.
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When an FDA panel voted in June 2005 against recommending approval of Acorn Cardiovascular's (New Brighton, Minnesota) CorCap cardiac support device, company officials told reporters Acorn remained "confident and committed" to working with FDA to win eventual approval.
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The race to develop and commercialize a second-generation drug-eluting stent (DES) is poised to heat up in the second half of this year.
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Reporting in a recent issue of Mayo Clinic Proceedings, researchers at the Mayo Clinic (Rochester, New York) determine that it is safe, more convenient and less costly for many patients to undergo coronary angiography and elective valve surgery on the same day.
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Jeremy Curtis has been named VP of worldwide marketing of ATS Medical (Minneapolis), a manufacturer of proucts and services for cardiac surgery. Curtis most recently was general manager, diagnostic cardiology marketing, for GE Healthcare.
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Abbott Laboratories (Abbott Park, Illinois) last week reported completing final submission of its premarket approval (PMA) application to the FDA for its Xience V everolimus-eluting drug-eluting stent (DES) system to treat coronary artery disease.
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Now that IRBs have both the final guidance on unanticipated problems and adverse events from the Office for Human Research Protections (OHRP) of Rockville, MD, and the draft guidance from the Food and Drug Administration (FDA), their duties in handling these issues should be clear, right?
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In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting Improving Human Subject Protection."
