As the most prevalent cardiac arrhythmia, atrial fibrillation has given rise to a multitude of interventions with variable effectiveness. While drug-based interventions have certainly seen success, as of late, ablation procedures have received significant interest among organizations looking to grow their cardiac service lines through the addition of new services. However, organizations seeking to develop AF ablation programs are likely to encounter a number of barriers along the way.
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Last year, the Roundtable reported on the results of CardioMEMS Inc.’s CHAMPION trial, but despite seemingly favorable data, the FDA’s Circulatory System Devices panel this week recommended the FDA not approve the device based upon issues noticed with the trial design that may have impacted results. In particular, the FDA’s panel took issue with an apparent violation of approved pre-market approval (PMA) protocols. Following the FDA clinical-site inspections, it was discovered that vendor-provided emails on suggested treatments occurred in as much as 10 percent of study subjects within the treatment group. With many FDA panelists explaining there was no way to determine whether the device or the care protocols were responsible for results, the decision fell 3-7 against device effectiveness.
Pre-market approval (PMA) protocols outlined specific actions to be taken by physicians when readings suggested the need for intervention. However, CardioMEMS nurses apparently sent emails directly to physicians, influencing treatment decisions and ultimately confounding results.
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Eric Bushlow, Cardiovascular Roundtable
Cardiovascular programs continue to search for innovative solutions to improve longitudinal care delivery and ensure patients are managed in the most appropriate post-acute settings. Remote monitoring for patients receiving pacemakers has long been suggested as an opportunity to improve the quality—and cost—of care along the continuum. Given the relative nascence of the technology, however, the impact of remote monitoring compared to other more established post-acute management strategies remains not well understood. However, a recent study published in the European Heart Journal examines the potential for remote-monitoring of pacemaker recipients to curb costs and improve quality of care.
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In a recent study published in Lancet, the authors state that everolimus-eluting stents are better than second generation paclitaxel-eluting stents in unselected patients in terms of safety and efficacy. In a letter responding to this article, Dr. Dawkins, Associate Chief Medical Officer at Boston Scientific, asserts that the researcher's conclusion is premature based on the available evidence. A second letter to the editor on this topic proposes that hypersensitivity to nickel may explain the difference in outcomes.
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Guidant, a subsidary of Boston Scientific, pleaded guilty to charges of withholding information about catastrophic failures of ICDs from the FDA. More specifically, Guidant admitted to "(1) making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and (2) failing to notify the FDA of a "correction" to the Contak Renewal device, which the company made to reduce a risk to health caused by the devices." Guidant has agreed to pay in excess of $296 million in penalties, the largest criminal penalty ever imposed on a device manufacturer for violating FDA act. The plea agreement has yet to be approved by the judge reviewing the case.
The charges originate from the June 2005 recalls of the devices due to the potential for the wire insulation to deteriorate, which could cause the device to short circuit and fail to deliver shocks. Two death are thought to have been caused by the defect.
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