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Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States

2012; Elsevier BV; Volume: 94; Issue: 6 Linguagem: Inglês

10.1016/j.athoracsur.2012.09.040

1552-6259

Michael A. Acker, Francis D. Pagani, Wendy Gattis Stough, Douglas L. Mann, Mariell Jessup, Robert L. Kormos, Mark S. Slaughter, Timothy Baldwin, Lynne W. Stevenson, Keith D. Aaronson, Leslie W. Miller, David C. Naftel, Clyde W. Yancy, Joseph G. Rogers, Jeffrey J. Teuteberg, Randall C. Starling, Bartley P. Griffith, Steven W. Boyce, Stephen Westaby, Elizabeth D. Blume, Peter D. Wearden, Robert Higgins, Michael J. Mack,

Cardiac Structural Anomalies and Repair

The regulatory assessment of MCS device technologies in the United States is complex owing to the sophistication of devices and quickly evolving nature of device development in this country. The current regulatory evaluation of devices is lengthy owing to a number of critical factors including lack of consensus on trial designs, meaningful outcomes for trials, and statistical methodologies to assess outcomes, lack of available and robust data to serve as comparator, multiple device indications, lack of uniform preclinical testing standards, and differing regulatory and reimbursement requirements. All parties uniformly agreed that introduction of innovative methodologies to conduct the preclinical and clinical evaluation of MCS devices is necessary to foster an environment of device innovation and improve assessments of safety and efficacy and efficiency of the regulatory process in the United States. The challenge for the field will be to ensure that all stakeholders in the process benefit from changes to the regulatory procedures, with safety and efficacy being of paramount and fundamental importance in guiding the decision process. It is critical for experts in the field to be actively involved and to partner with the FDA in all aspects of MCS development, including trial design, outcome assessments, data interpretation, and regulatory evaluation. Active involvement of CMS in this process is also critical for efficient introduction of devices into clinical practice. Professional societies may be uniquely positioned to provide a mechanism for bringing together a balanced group of experts (academic researchers and clinician leaders) who can engage with the FDA. The health burden of heart failure in the United States increases the urgency of the mandate for change.