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CURRICULUM VITAE Samuel J. DeMaio, MD Page !1 CURRICULUM VITAE SAMUEL J. DEMAIO, MD Office Address: Star State Heart, P.L.L.C. d/b/a/Star State Heart & Vascular, P.L.L.C. 200 Medical Pkwy, Suite 270 Lakeway, TX 78738 Date of Birth: January 5, 1957 (Newark, NJ) EDUCATION 1975-1979 B.S.E.E. - High Honors: Rutgers College of Engineering (New Brunswick, NJ) Sept.79-May 83 M.D.: UMDNJ - New Jersey Medical School (Newark, NJ) July 83-June 84 Internship - Internal Medicine: Baylor University (Dallas, TX) John S. Fordtran, M.D., Chief July 84-June 86 Residency - Internal Medicine: Baylor University (Dallas, TX) John S. Fordtran, M.D., Chief July 86-June 89 Fellowship - Cardiology: Emory University (Atlanta, GA) R. Wayne Alexander, M.D., PhD., Chief Jan.89-June 89Fellowship - Electrophysiology: Emory University (Atlanta, GA) Paul F. Walter, M.D. July 89-June 90 Fellowship - Interventional Cardiology: Emory University (Atlanta, GA) Spencer B. King, III, M.D., Chief July-Sept 1990 Fellowship - Interventional Cardiology (Peripheral Vascular Disease): University of Munich (Six weeks) Berthold Hoefling, M.D., Chief 1994-May 1999 J.D.: Southern Methodist University School of Law (Dallas, TX). Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !2 EMPLOYMENT Medical: 2012 – Present Star State Heart, P.L.L.C. d/b/a/Star State Heart & Vascular, P.L.L.C. 200 Medical Pkwy, Suite 270 Lakeway, TX 78738 2012 – 2012 Star State Heart, P.L.L.C. d/b/a/Star State Heart & Vascular, P.L.L.C. 1008 RR 620 South, Suite 250 Austin, TX 78734 2010 – 2012 Star State Heart, P.L.L.C. d/b/a/Star State Heart & Vascular, P.L.L.C. 1400 George Dieter Drive, Suite 110 El Paso, TX 79936 2009-2010 Capital Cardiovascular Consultants, P.L.L.C. d/b/a/Capital Cardiovascular Specialists, P.L.L.C. (Group formerly known as Austin Cardiovascular Associates) 1400 George Dieter Drive El Paso, TX 79936 2002-2010 Capital Cardiovascular Consultants, P.L.L.C. d/b/a/Capital Cardiovascular Specialists, P.L.L.C. (Group formerly known as Austin Cardiovascular Associates) 4207 James Casey; Suite 215; Austin, TX 78745 512-445-5998 2001-2002 Austin Cardiovascular Associates 4207 James Casey; Suite 215; Austin, TX 78745 512-445-5998 1990-2001 Texas Cardiology Consultants 712 N. Washington; Suite 300; Dallas, TX 75249-1633 (214) 824-8721 Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !3 1993-1994 Law: 2002 to Present 1999-2002 HOSPITAL AFFILIATIONS: Assistant Editor, American Journal of Cardiology Girards Law Firm 10000 North Central Expressway, Ste 750 Dallas, TX 75231 Inactive Buchholz, Sassin and DeMaio 325 N. St. Paul; 4000 Republic Center Tower II Dallas, TX 75201 Lakeway Regional Medical Center (2012-present) 100 Medical Pkwy Lakeway, Texas 78738 East El Paso Physicians Medical Center (2009-2012) 1400 George Dieter El Paso, Texas Chief of Cardiology Lakeside Hospital at Bastrop (2006-2009) 3201 Highway 71 East Bastrop, TX 7802 Heart Hospital of Austin (2002-2009) 3801 North Lamar Boulevard Austin, TX 78756 Daughters of Charity Health Services of Austin d/b/a Seton Medical Center (2002-2009) 1201 West 38th Street; Austin, TX 78705 South Austin Hospital (2001- 2/2009) 901 West Ben White Boulevard; Austin, TX 78745 Director of Cardiac Cath Lab and Interventional Cardiology (2004) Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !4 The Hospital at Westlake Medical Center (2005-2008) Director of Cardiology Member of Medical Executive Committee 5656 Bee Cave Road M-302 Austin, TX 78746 Baylor University Medical Center (1992-2001) 3500 Gaston Avenue; Dallas, TX 75246 St. Paul Medical Center (1992-2001) 5909 Harry Hines Blvd.; Dallas, TX 75235 HONORS: 1977: Tau Beta Pi - National Engineering Honor Society 1977: Eta Kappa Nu - National Electrical Engineering Honor Society 1983: Alpha Omega Alpha - Medical Honor Society 2011: American Academy of Nurse Practitioners – State Award for Excellence FELLOWSHIP/ MEMBERSHIP: Fellow - American College of Cardiology Fellow - American College of Physicians Fellow - Society of Cardiovascular Angiography and Interventions American Medical Association American Heart Association American College of Chest Physicians North Texas Cardiovascular Society - President 1993 CERTIFICATION: Diplomate - National Board of Medical Examiners, #274922, March 1984 Diplomate - American Board of Internal Medicine, #106453, September 1986 Diplomate - ABIM - Cardiovascular Disease, #106453, November 1989 North American Society of Pacing and Electrophysiology - Special Competency, Cardiac Pacing, September 1991 Diplomate - ABIM - Interventional Cardiology, 1999. Diplomate-Recertification –ABIM- Interventional Cardiology, October 2009. LICENSES: Revised March 2016 Legal: State of Texas Bar #24012519 State of Arkansas Bar #2000 063 Medical: State of Texas #G6655 CURRICULUM VITAE Samuel J. DeMaio, MD Page !5 State of Georgia #028157 (inactive) BIBLIOGRAPHY Papers and Chapters Published: 1. Haft JI, DeMaio SJ, Bartoszyk OB: The coronary arteriographic findings in symptomatic patients with right bundle branch block. Am J Cardiol 1984; 53:770-773. 2. DeMaio SJ, Dinsella SH, Silverman ME: Clinical course and long-term prognosis of spontaneous coronary artery dissection. Am J Cardiol 1989; 64:471-474. 3. DeMaio SJ, Walter PF, Crawley SI: Cardiac arrhythmias: Their identification and management. In: The Emory University Comprehensive Board Review in Internal Medicine. Presented in Atlanta, GA on August 3, 1989. 4. DeMaio SJ: Sudden cardiac death. In: Schlant RC, Hurst JW (eds), The Heart, 7th Companion Handbook, New York, McGraw Hill Inc., 1990; 6:56-60. 5. DeMaio SJ, Walter PF, Douglas JS: Treatment of ventricular tachycardia induced cardiogenic shock by percoronary chemical ablation. Cath and Cardiovasc Diag 1990; 21:170-176. 6. DeMaio SJ: Surgical and catheter ablative therapy of ventricular arrhythmias. In: Hurst JW (Ed), Current Therapy in Cardiovascular Disease -3, Philadelphia, B.C. Decker, Inc., 1991. 7. DeMaio SJ: Surgical and catheter ablative therapy of supraventricular arrhythmias. In: Hurst JW (Ed), Current Therapy in Cardiovascular Disease-3, Philadelphia, C.B. Decker Ind., 1991. 8. Hearn JA, DeMaio SJ, Roubin GS, Hammarstrom M, Sgoutas DS: Predictive value of lipoproteins in the angiographic diagnosis of coronary artery disease. Am J Cardiol 1990; 66:1176-1180. 9. Bauriedel G, DeMaio SJ, Hoefling B: The role of angioscopy in the treatment of peripheral vascular disease with percutaneous atherectomy. Am J Cardiol 1991; 68:226-231. 10. Bauriedel G, Windsetter U, DeMaio SJ Kandolf R, Hoefling B: Human coronary and peripheral arterial smooth muscle cell activity in primary and restenotic lesions obtained by percutaneous atherectomy. Circulation 1992; 85:554-564. 11. DeMaio SJ, King III SB, Lembo NJ, Roubin GS, Hearn JA, Bhagavan HN, Sgoutas DS: Vitamin E supplementation, plasma lipids and incidence of restenosis after percutaneous transluminal coronary angioplasty (PTCA). J of the Am Col of Nutrition 1992; Vol. II, No. 1, 68-73. Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !6 12. Bauriedel G, DeMaio SJ, Hoefling B: Sheath introducer technique for recanalizing total occlusions of the superficial femoral artery. Cath and Cardiovasc Diag 1992; 25:66-70. 13. DeMaio SJ, Stocker E: Surgical and catheter ablative therapy of ventricular arrhythmias. In: Hurst JW (Ed), Current Therapy in Cardiovascular Disease-4, Philadelphia, B.C. Decker Inc., 1994. 14. DeMaio SJ, Stocker E: Surgical and catheter ablative therapy of supraventricular arrhythmias. In: Hurst JW (Ed), Current Therapy in Cardiovascular Disease-4, Philadelphia, B.C. Decker Inc., 1994. 15. Weintraub WS, Boccuzzi SJ, Klein JL, Kosinski AS, King SB, Ivanhoe R, Cedarholm JC, Stillabower ME, Talley JD, Samuel J. De Maio, Robbins DC, Brown CL, Alexander RW, and the Lovastatin Restenosis Trial Study Group: Lack of effect of Lovanstatin on restenosis after coronary angioplasty. N Engl J Med 1994; 1331:1331-7. 16. Richard O. Han, MDa, Robert S. Schwartz, MDb, Yoshiki Kobayashi, MDh, Stephanie H. Wilson, MD, J.Tift Mann, MDc, Michael H. Sketch, MDd, Robert D. Safian, MDe, Alexandra Lansky, MDf, Jeffrey Popma, MDg, Peter J. Fitzgerald, MD, PhDh, Igor F. Palacios, MDa, Marilyn Chazin-Caldie, MSi, Sheldon Goldberg, MD, For the Stent COmparative REStenosis (SCORES) Trial Investigators Comparison of self-expanding and balloon-expandable stents for the reduction of restenosis Am. J. Card. 2001: 88(3), p253-259. (Principle Investigator—Dallas). 17. Rothenberg, F, Franklin, JO, DeMaio, SJ. Use, value, and toxicity of amiodarone. Heart Dis Stroke ;2004: 3:19-23 20. Harvey, LAC, DeMaio SJ, Roberts, WC: Radiation-induced cardiovascular disease including stenosis of coronary ostium, coronary and carotid arteries, and aortic valve. BUMC Proceedings 1994:7(3):33-36. 20. Perin, EC, DeMaio, SJ, George, B, O’Neill, WW. Percutaneous laser revascularization in patients with chronic total occlusions. Letter to the Editor. J Am Coll Cardiol, 2002; 40:2062. 21. Whitlow PL, DeMaio SJ Jr, Perin EC, O'Neill WW, Lasala JM, Schneider JE, McKeever LS, Ezratty AM, Knopf WD, Powers ER, Shawl FA; Eclipse Investigators. One-year results of percutaneous myocardial revascularization for refractory angina pectoris. Am J Card. 2003;91(11): 1342-6. 22. Moses, J, et. al., Sirolimus-Eluting Stents versus Standards Stents in Patients with Stenosis in a Native Coronary Artery. N. Eng. J. Med. 2003; 349(14) p.1315-1323. (Principle Investigator— Dallas. Baylor University Medical Center). Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !7 23. David R Holmes, Jeffrey Moses, Martin Leon, Mark Midei, Michael Mooney, Donald Baim, Samuel De Maio, Jeffrey Popma, Richard Kuntz. Sirolimus versus plain old balloon angioplasty small vessels. Journal of the American College of Cardiology. 3 March 2004 (Vol. 43, Issue 5, Supplement 1, Page A35) 24. Stone, Greg, et.al., A Polymer-Based, Pactlitaxel-Eluting Stent in Patents with Coronary Artery Disease. N. Eng. J. Med. 2004; 350(3):221-131. (Principle Investigator—Austin, Texas). 25. Sawhney, N Moses, JW, Leon MB, Kuntz RE, Popma, JJ, Bachinsky, W, Bass, T, DeMaio, SJ, Fry, E Holmes, DR Jr, Teirstein, PS. Treatment of left anterior descending coronary artery disease with sirolimus-eluting stents. Circulation; 2004 July 27;110(4):374-9. 26. Gregg W. Stone, M.D., Stephen G. Ellis, M.D., David A. Cox, M.D., James Hermiller, M.D., Charles O'Shaughnessy, M.D., James Tift Mann, M.D., Mark Turco, M.D., Ronald Caputo, M.D., Patrick Bergin, M.D., Joel Greenberg, M.D., Jeffrey J. Popma, M.D., Mary E. Russell, M.D., for the TAXUS-IV Investigators: A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease. N. Eng. J. Med. 2004; 330; p221-231 (Principle Investigation—Austin) 27. Drenth, D, Zijlstra, F, Boonstra, PW, Sawhney, N, Teirstein, PS, Moses, JW, Leon, MB, Kuntz, RE Popma, JJ, Bachinsky, W, Bass, T, DeMaio, SJ, Fry, E, Holmes, DR,Jr. Letter Regarding Article by Sawhney et al, "Treatment of Left Anterior Descending Coronary Artery Disease With SirolimusEluting Stents” Response. Circulation, Apr 2005; 111: e265 - e266. 28. Stone, Gregg W., DeMaio, Samuel, et. al: Comparison of a Polymer-Based Paclitaxel-Eluting Stent with a Bare Metal Stent in Patients with Complex Coronary Artery Disease. TAXUS V Investigators. JAMA; September 14, 2005: 294 (10): 1215-23. 29. Stephen G. Ellis, Samuel DeMaio, et. al.: Final 5Year Outcomes from the TAXUS V de novo Trial: LongTerm Safety and Effectiveness of the PaclitaxelEluting TAXUS Stent in Complex Lesions. Am J Cardiol. 2009;104(suppl):135D. Presented TCT 365 (2009). Abstracts Published 1. Haft JI, DeMaio SJ, Schlanger LI: Left ventricular ejection fraction abnormalities in patients with mitral valve prolapse. Clin Research 1981; 19(2):202A. 2. Hearn JA, DeMaio SJ, Roubin GS, Hammarstrom M, Sgoutas DS: Apolipoproteins, Lp(a), and lipids in the prediction of coronary artery disease. Arteriosclerosis 1989;9:(5):739a. 3. Bauriedel G, Ganesh S, Heidemann P, Heimeri J, DeMaio SJ, Kandolf R, Hoefling B: Concordant Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !8 anti-proliferative and anti-migratory effects of cardiovascular drugs on human plaque smooth muscle cells. Am J Cardiol 1992; 19:3:suppl A. 4. Moses, Jeffery W. for the SIRIUS Principal Investigators: Sirolimus-eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery. New England Journal of Medicine 2003; 349(14). 5. Kereiakes, Dean J. for the AMEthyst Principal Investigators: A Novel Filter-Based Distal Embolic Protection Device for Percutaneous Intervention of Saphenous Vein Graft Lesions. JACC: Cardiovascular Interventions 2008; Vol.1, No. 3. MEDICAL ADVISORY BOARDS 1. SCI-MED/Boston Scientific Medical Advisory Board: 1990-2007. 2. SCI-Med/Peripheral Vascular Advisory Board: 1998 - 2007. 3. Bard/St. Jude Cardiac Assist-Intravascular Advisory Board: 1994-1998. 4. Medtronic/ AVE, President Advisory Board-Coronary and Peripheral Angioplasty - 1999-2006. 5. Baylor PTCA (Percutaneous Transluminal Coronary Angioplasty) Task Force: Chairman 1994-1996. 6. Cordis Corporation: Coronary and Peripheral Medical Advisory Board: 1999-2007. PATENTS U.S. Patent #5540798: Durphy-DeMaio Ulti-Cath. (angioplasty balloon catheter) HDE DEVICES 1. 2. 3. JOSTENT Coronary Stent Graft. IRB# 02-06-03. CardioSEAL Septal Occlusion System for PFO Closure. IRB # 03-05-07. Amplatzer PFO Occluder (ASD Occluder certified). IRB # 04-01-05. COMPLETED RESEARCH Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !9 1. SCIMED Big Skinny Percutaneous Transluminal Coronary Angioplasty Catheter. IRB# 091-022. 86821216. Drug-Eluting Collar on Standard Telectronics Lead. IRB# 091-023. 3. A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Lovastatin on the Prevention of Coronary Restenosis Following Percutaneous Transluminal Coronary Angioplasty. IRB# 091-053. 4. Cost-Effectiveness of Lovastatin in the Prevention of Restenosis After Percutaneous Transluminal Coronary Angioplasty. IRB# 091-106. 5. SCIMED RALLY Percutaneous Transluminal Coronary Angioplasty Catheter. IRB# 092-019. 6. Coronary Thrombolysis in Patients with Acute Myocardial Infarction, Multicenter Study with Prourokinase (FCE 26177) and t-PA Co-Administration. IRB# 092-087. 7. Quality of Life Substudy of the Lovastatin Restenosis Trial. IRB# 092-104. 8. The Role of Percutaneous Angioscopy in Detecting and Treating Occlusive Disease in Saphenous Vein Grafts. IRB# 092-120. 9. A Randomized, Open-Label Parallel Study to Evaluate the Effects of Fluosol on Complications, Duration of Hospital Stay, and Left Ventricular Function in Coronary Angioplasty Patients at High Risk of Hemodynamic Deterioration. IRB# 093-039. 10. Myocardial Infarction Cost Study. IRB# 093-047. 11. FIRST (Five Year Required Surveillance Trial) Intracoronary Stenting Using 20 mm Long Stainless Steel Gianturco-Roubin Flex-Stent® for Acute or Threatened Closure PMA#910030. IRB# 094-105. 12. SCIMED Biomaterials Procurement Program, IRB# 094-108. 13. Stent Anti-thrombotic Regimen Study Protocol- STARS Trial, IRB# 095-068. 14. SCIMED LC-60 PTCA Catheter Investigational Plan, IRB# 096-025. 15. SCIMED Stent Comparative Restenosis Trial - SCORES Trial, IRB# 096-047. 16. The Study of the Safety and Effectiveness of Percutaneous Transluminal Myocardial Revascularization in Patients with Class III or IV Angina -Phase II, IRB# 097-089. Sponsor: Eclipse Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !10 Surgical Technologies, Inc. 17. The Palmaz-Schatz® MiniCrown Balloon Expandable Stent with the PowerGripTM Over-The-Wire Stent Delivery System for Treatment of Abrupt or Threatened Vessel Closure, IRB# 098-055. 18. Cordis Velocity Abrupt or Threatened Vessel Closure, #P99-4201. 19. Medtronic AVE Predict Trial for Primary Stenting - Randomized, IRB# 099-088. 20. Medtronic AVE Saphenous Vein Graft (SVG) Registry Trial. IRB# 099-126 21. The Sirolimus-Coated Bx-Velocity Balloon-Expandable Stent in the treatment of patients with denovo native coronary artery lesions. The SIRIUS Trial. IRB #001-004. 22. A multicenter trial of localized radiation therapy to inhibit restenosis. GAMMA V. IRB# 000-057. 87523216.Cilostazol for restenosis trial. CREST. IRB#01-12-02 87523217.Medtronic SAVE PACe Study evaluating the Search AV Extension for promoting Atrioventricular Conduction. IRB# 03-05-01. 87523218.Medtronic AVE MAVErIC II Trial to evaluate the carotid stent system with distal protection in Carotid Arteries. IRB# 03-02-03. 87523219.Emboshield and Xact Post Approval Carotid Stent Trial using the Emboshield BareWire Rapid Exchange Embolic and Xact Rapid Exchange Carotid Stent System- The EXACT Study. IRB # 06-02-03. 87523220.The Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter Systems AMEthyst Trial. IRB # 04-02-02. 87523221.A Phase II Evaluation of the Safety and Efficacy of the TriVascular ENOVUS Stent Graft System in the Treatment of Abdominal Aortic Aneurysms. IRB #05-04-02- Study Halted prior to initiation 87523072.A prospective, randomized trial evaluating TAXUS SR Paclitaxel-eluting primary stent in denovo coronary lesions. TAXUS IV. IRB#01-12-03. 87523073.The Sirolimus- Eluting 4.0mm Bx Velocity Balloon Expandable Stent in the treatment of patients with de-novo coronary lesions. SIRIUS 4.0. IRB# 03-07-02. 87523074.A randomized trial evaluating the TAXUS SR Paclitaxel- Eluting Coronary Stent in the treatment Revised March 2016 CURRICULUM VITAE Samuel J. DeMaio, MD Page !11 of high risk lesions. TAXUS V- DENOVO. IRB # 03-02-01. 87523075.A randomized trial evaluating the TAXUS SR Paclitaxel-Eluting Coronary Stents in the treatment of In-stent Restenosis. TAXUS V- ISR. IRB # 03-09-02. 87523076.Medtronic AVE MAVErIC III Trial evaluating the carotid stent system with distal protection using the Interceptor PLUS Filter system. MAVErIC III. IRB #04-10-04. 87523077.A Randomized, Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary stent Versus the TAXUS Paclitaxel-Eluting Coronary Stent System in DeNovo Native coronary Artery Lesions. ENDEAVOR IV. IRB # 05-05-01. 87523078.Asymptomatic Carotid Stenosis, Stenting versus Endarterectomy Trial- ACT 1 Study. IRB # 06-07-02. 87523079.Carotid Stenting for High surgical risk patients: Evaluating Outcomes through the collection on Clinical Evidence. CHOICE. IRB # 07-02-02. 87523080.A Prospective, Single-Blind, Randomized, Multicenter, Study Comparing the CYPHER ELITE And The CYPHER Bx VELOCITY Sirolimus-Eluting Stent Systems. ELITE. IRB # 07-09-02. 87523081.Gauging Responsiveness with a VERIFYNOW Assay - Impact on Thrombosis and Safety. GRAVITAS. IRB # 08-05-01. 87523082.A Clinical Evaluation of the Medtronic Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Native Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25mm to 4.2mm. RESOLUTE. IRB # 08-09-05. 87523083.XIENCETM V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study. XIENCE V. IRB # 08-11-06. Revised March 2016