Whitepapers

Publications (Selected List):

1. Baim DS, Donovan A, Smith JJ, Feigal D, Briefs N, Geoffrion R, Kaplan AV. Medical Device Development: A Balanced Approach to Managing Conflicts of Interest Encountered by Physicians. Cathet Cardiovasc Intervent 2007 69:655-664.

2. Baim DS, Mehran R, Kereiakes DJ, Gross TP, Simons M, Malenka D, Kaplan AV. Post Market Surveillance cardiovascular devices: A comprehensive approach. Circulation 2006 113:891-897.

3. Fann JI, Chronos N, Rowe S, Michels R, Lyons B, Leon MB, Kaplan AV. Evolving Strategies for the Treatment of Valvular Heart Disease: Preclinical and Clinical Pathways for Percutaneous Aortic Valve Replacement. Cathet Cardiovasc Intervent 2008 71:434-440.

4. Kaplan AV, Harvey ED, Kuntz RE, Shiran H, Robb JF, Fitzgerald P. Humanitarian Use Devices (HUD)/Humanitarian Device Exemptions (HDE) in Cardiovascular Medicine. Circulation 2005 112:2883-2886.

5. Kaplan AV, Lukovits T, Robb JR. PFO Closure for Prevention of Recurrent Stroke in Patients after Cryptogenic Stroke: The imperative of completing randomized controlled trials. Cathet Cardiovasc Intervent 2007 69:6-8.

6. Kaplan AV, Baim DS, SmithJJ, Feigal DA, Simons MS, Jefferys D, Fogarty TJ, Kuntz RE, Leon MB. Medical Device Development: From Prototype to Regulatory Approval. Circulation 2004 109:3068-3072.

7. Kaplan AV, Williams DO. The Medical Device Regulatory Landscape: The Imperative of Finding Balance. Circ Cardiovasc Interv. 2012; 5:2-5.

8. Malenka DJ, Kaplan AV, Sharp SM, Wennberg JE. Device implementation and outcomes: Use of Medicare Claims. Health Affairs 2005: 24:1-10.

9. Malenka DJ, Kaplan AV, Lucas FL, PhD, Sharp SM, Skinner JS. Two Year Outcomes of Coronary Stenting in the Era of Bare Metal versus Drug Eluting Stents: Analysis of the Medicare Claims Made Data Base. Journal of the American Med Assoc 2008 299:2868-2876.

10. Mehran R, Leon MB. Feigal DA, Jefferys D, Simons MS, Chronos N, Fogarty TJ, Kuntz RE, Baim DS, and Kaplan AV. Post-market Approval Surveillance: A call for a more integrated and comprehensive approach. Circulation 2004 109: 3073-3077.

11. Popp RL, Lorell BH, Stone GW, Laskey W, Smith JJ, Kaplan AV. The Role of Public Registration in the Conduct of Medical Device Trials. J Am Coll Cardiol, 2006; 47: 1518-1521.