![]() Jude Medical) the Lutonix 035 drug-coated balloon (Lutonix) the IN.PACT Admiral drug-coated balloon (Medtronic), the Melody valve (Medtronic) the ResQCPR System (Advanced Circulatory Systems) the Watchman left atrial appendage closure device (Boston Scientific) Sapien 3 (Edwards Lifesciences) the Cheatham Platinum stent (NuMED) and the Micra pacemaker (Medtronic).įor these devices, there were 18 pivotal studies. Making their case, Redberg and colleagues identified 14 cardiovascular device approvals stemming from priority review between 20: the Sapien valve (Edwards Lifesciences), approved separately for transfemoral and transapical delivery the Synergy Ablation System (AtriCure) the S-ICD subcutaneous implantable defibrillator system (Boston Scientific) MitraClip (Abbott Vascular) the CardioMEMS HF System (St. Newer devices are only able to meet this need if they are actually safe and effective, Redberg added. Critical in this discussion, she said, is knowing exactly how “unmet clinical need” is defined, when surgery and medical therapies can be alternative options. Redberg, for her part, didn’t seem convinced that the technologies in question merit any less stringent of a look. Meeting the needs of “patients with limited or no therapeutic alternatives and still having less than perfect data will always be a subject that invites both criticism and praise,” Kandzari said. ![]() Therefore, they were believed to qualify through this expedited pathway.” Another factor worth noting, he added, is that these products were considered on a case-by-case basis, with the idea that they “represent solutions to unmet clinical needs. This analysis’ approach, spanning 10 years of approvals and a diverse range of devices, “is very much an oversimplification,” Kandzari stressed. Should we as cardiologists be accepting, and using in our patients, devices that don’t really have evidence that they’re better than the alternative in a lot of cases? Rita Redberg “By most instances, the medical community feels that the FDA has been too conservative, too rigorous, too evidence-based,” Kandzari commented to TCTMD, noting that this new report, as well as a recent documentary, The Bleeding Edge, argue the opposite: that the FDA’s approval process is flawed. Dhruva, MD (Yale University School of Medicine, New Haven, CT).īut not all hold this view, emphasized David Kandzari, MD (Piedmont Heart Institute, Atlanta, GA). Camille Jones, MS (University of California, San Francisco), and Sanket S. ![]() ![]() Redberg co-authored the letter along with L. This is especially notable, she said, given that the devices’ priority-review status would imply they had “special features,” she said. “Before we approve and start using high-risk devices, particularly implanted ones, we should have high-quality evidence that they’re going to be safe and effective, and I think that we found that the evidence was not high-quality,” Rita Redberg, MD (University of California, San Francisco), told TCTMD, pointing out that for nearly half of the devices considered by an FDA panel, votes did not come down in favor of effectiveness. Over the past decade, the body of evidence in support of high-risk cardiovascular devices that got expedited approval from the US Food and Drug Administration (FDA) has been decidedly lackluster, asserts a research letter published online last week in JAMA Internal Medicine. ![]()
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