The creation of an FDA program to finalize the classification of high-risk devices that are already in widespread use has left clinicians arguing whether the bar should be raised on the evidence required for approval.
Two editorials online in JAMA Cardiology debated the case of the Impella heart pump, one of the first class III devices to go through this pathway, which was launched in 2009 as the 515 Program Initiative.
Impella was previously given temporary 510(k) clearance in 2008 as the FDA bought time to decide whether to require a more rigorous premarket approval application or not. While the FDA eventually did require that step, Impella was approved using data of “uncertain clinical significance,” according to Joseph S. Ross, MD, MHS, of Yale-New Haven Hospital, and colleagues.
The Impella percutaneous ventricular assist device (PVAD) won official approval as a class III device in 2015.
Importantly, for the approval process, “large-scale, real-world outcomes assessments of the Impella could not be conducted with electronic health records and administrative claims data, as there is no way of identifying which type of PVAD patients receive,” Ross’ group wrote.
“Though the FDA faces the difficult task of requiring meaningful evidence for approval without placing undue burden on manufacturers … there should be ample opportunity for manufacturers to conduct large, robust clinical studies examining patient-important outcomes to ensure that patients and physicians may continue using these high-risk devices with assurance of their safety and effectiveness,” they wrote in an editorial.
Yet Richard L. Page, MD, of University of Wisconsin School of Medicine and Public Health in Madison, partly disagreed, writing in a separate editorial that “much more important than the consideration of burden on the manufacturer” is the continued availability of life-saving technology like PVADs.
Page, who was chair of the Circulatory System Devices Panel that considered reclassification of the Impella, maintained that “we must not be so critical of the data available that we withhold potentially life-saving devices, from the physician and the patient, that are already in clinical use.”
He wrote that “it would have been unreasonable to expect new, randomized, prospective studies of this device, and it would have been unfair to withhold this therapy pending such study. The precedence of the Impella device provides reassurance that similar premarket approval can be achieved for other preamendment class III devices such as the automated external defibrillator.”
To that end, “the FDA has begun implementing a unique device identification system to facilitate postmarket surveillance using routinely collected health information, which may enhance evaluations of 515 Program Initiative devices already in widespread use,” noted Ross and colleagues.
“However, until this system is in place, manufacturers may propose that the FDA consider potentially problematic historical evidence in support of approval, including clinical data from the literature, existing patient registries, or prior trials,” the group emphasized.
Ross reported receiving research support from Medtronic, Johnson & Johnson, the U.S. FDA, the Blue Cross Blue Shield Association, and Centers for Medicare & Medicaid Services.
Page disclosed serving as chairperson of the Circulatory System Devices Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health.
Rathi VK, et al “The US Food and Drug Administration 515 program initiative: addressing the evidence gap for widely used, high-risk cardiovascular devices?” JAMA Cardiol 2016; DOI: 10.1001/jamacardio.2016.0002.
Page RL “The US Food and Drug Administration premarket approval process and the 515 program initiative: view from a panel chair” JAMA Cardiol 2016; DOI: 10.1001/jamacardio.2016.0007.