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Pedro Eerdmans, MD, PhD

Director, Global Strategy Services

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expertise areas:

Clinical, EU MDR, Notified Body Expertise, Regulatory

Dr. Pedro Eerdmans has more than 25 years of experience within the medical device industry, with a deep understanding in the medical device development from concept to market release and post market follow-up.

Dr. Eerdmans has held several different positions within the medical device industry, including Chief Executive Officer (CEO), Chief Medical Officer (CMO), Vice President Medical Affairs, Director, Manager and Physician. He has experiences in almost all levels of the medical device space, including hospitals, Contract Research Organizations (CROs), manufacturers (4-30,000 employees) and Notified Body. While head of the Notified Body, he managed to obtain EU MDR accreditation, and as Medical Director he was responsible for the evaluation of the medical evidence to grant CE certification. He also managed global clinical teams while based in Europe and the U.S. (Houston, Texas). Under his supervision, several medical devices received CE mark, most recently 3 Investigational Device Exemption (IDE) approvals were granted.

Dr. Eerdmans studied medicine at the University of Maastricht (Netherlands), received a Master Degree in Medical and Pharmaceutical Research from the University of Brussels (Belgium) and obtained a PhD in Pharmacology at the University of Maastricht (Netherlands). He has authored more than 30 publications including two Lancet publications.

CORE COMPETENCIES

  • Providing and evaluating overall company strategies for regulatory, clinical and reimbursement
  • Acting as fractional CMO to internal and external partners
  • Acting as a board member and/or advisor
  • Building clinical and regulatory teams
  • Setting up advisory boards
  • Developing clinical strategies for novel and established high-risk medical devices for global market release
  • Evaluating clinical data from the position of the Notified Body and its clinical experts
  • Therapeutic expertise:
    • Cardiology – heart valves, anterviovenous (AV) shunts, drug-eluting stents (DES), drug-eluting balloons (DEB), artificial hearts
    • Neurology – neuromodulation, deep brain stimulation (DBS), vagus nerve stimulation (VNS), spinal cord stimulation (SCS)
    • Hepatology – ascites treatment, implantable pumps
    • Urology – incontinence treatment sacral nerve simulation (SNS), benign prostatic hyperplasia (BPH), erectile dysfunction (ED)
    • Pain treatment – implantable pumps for pain
    • Orthopedics
    • Drug-device combinations

RECENT PROJECTS

  • Prepared clinical and regulatory strategies for:
    • Surgical navigation
    • Osteoarthritis device
    • Cardiac ablation
    • Activity measuring devices
    • Aesthetic devices

PUBLICATIONS

Abstracts

  • H.A. Eerdmans, G.H.I.M. Walenkamp, S.K. Bulstra, A.J. van der Linden. Effect van gentamicine op gewrichtskraakbeen. In: NTVG 1990;134,nr 3, pp 147-148.
  • H.A. Eerdmans, G.H.I.M. Walenkamp, S.K. Bulstra en A.J. van de Bogaard. Een septische-artritismodel met staphylococcus aureus bij de rat. In: NTVG 1990;134,nr 27, pp 1330.
  • H.A. Eerdmans, J.G.R. De Mey. Alpha1-adrenergic effects of clonidine on contractile reactivity of isolated mesenteric and renal resistance arteries of spontaneously hypertensive rats. In: Blood Vessels, vol 27, no 1, 35, 1990.
  • Acute effects of alpha-2 agonists in isolated mesenteric and intra-renal resistance arteries of 12 weeks old spontaneously hypertensive rats. In: European journal of Pharmacology, vol 183/3, 831-832, 1990.
  • H.A. Eerdmans, H.A.J. Struyker Boudier, J.G.R. De Mey. Con­trac­tile reac­tivity of isolated resistance arteries after 4 week treatment with rilmenidine, clonidine or hydralazine in spon­taneously hypertensive rats. In: Ricerca Scientifica ed educazione permanente suppl. N.90, 1991
  • H.A. Eerdmans, H.A.J. Struyker Boudier, J.G.R. De Mey. Com­ponents in­volved in resistance arter­ial respon­ses to elec­tri­cal field stimulation. In: Blood Vessels, vol 28, no 4, pp 286-287, 1991.
  • H.A. Eerdmans, H.A.J. Struyker Boudier, J.G.R. De Mey. Ef­fects of nerve stimulation on isolated mesenteric and intra-renal resistance arteries, shr versus wky. In: 7th International symposium on shr and related studies. (Lyon oktober,1991)
  • H.A. Eerdmans, J.J.M. Debets, J.F.M. Smits, J.G.R. De Mey. Redu­ced responsiveness to sympathetic nerve stimulation in perip­heral resistance arteries following myocardial infarction. In: Pharmaceutisch Weekblad, suppl. H, pp h5, 1991.
  • H.A. Eerdmans, M.C.J. Persoons, C.A. Bruggeman, J.G.R. De Mey. Effect of cytomega­lovirus infection in vivo on the reactivity of isolated resistance-sized arteries of the rat. In: The FASEB Journal, vol 6, no 4, part I, pp A1039, 1992.
  • Weil, P. Eerdmans, E. van Waalwijk van Doorn, G. Ralph, R. Janknegt. The effect of the alpha-1-adrenoceptor selective agonist midodrine on mild to moderate female stress-incontinence. In: Neurourology and Urodynamics, vol 13, no 4, pp 446-447, 1994.
  • H.J. Weil, P.H.A. Eerdmans, R.A. Janknegt. A new randomized study on neuromodulation versus conventional treatment for incontinence or dysfunctional voiding patterns; a preliminary report. In: Neurourology and Urodynamics, vol 15, no 4, pp 284-285, 1996.
  • A. Janknegt, E.H.J. Weil, P.H.A. Eerdmans. Two stage neuromodulation implant for refractory voiding dysfunctions: an attempt to improve the PNE testing score. In: Neurourology and Urodynamics, vol 15, no 4, pp 403-404, 1996.
  • Ernest H.J. Weil, Pedro H.A. Eerdmans, Ruud A. Janknegt. 5 year treatment of patients with severe voiding disorders, so called urological cripples, by neuromodulation. The facts. In: European Urology, vol 30, no S2, pp 236, 1996
  • Janknegt, E. Weil, P. Eerdmans. Improvement neuromodulation results for urge, urge incontinence and retention by two stage implant. In: European Urology, vol 30, no S2, pp 236, 1996
  • H.J. Weil, P.H.A. Eerdmans, R.A. Janknegt. Significant positive urodynamic changes 6 months after neuromodulation in 21 patients with urge-incontinence. In: European Urology, vol 30, no S2, pp 238, 1996
  • H.J. Weil, P. Eerdmans, R. Janknegt. Nerve stimulation system for the treatment of incontinence for dysfunctional voiding patterns. In: Articicial Organs, vol 20, no 11, pp 1260, 1996

Papers

  • H.A. Eerdmans, H.A.J. Struyker Boudier, J.G.R. De Mey. Sympathetic heterogeneity in mesenteric and renal resistance arteries. Resistance arteries, structure and function, ed. Mulvany et al, pp 156-159, 1991.
  • H.A. Eerdmans, H.A.J. Struyker Boudier, J.G.R. De Mey. Contractile reactivity of isolated resistance arteries after 4 week treatment with rilmenidine, clonidine or hydralazine in spon­taneously hypertensive rats. Journal of Hypertension, 9 (suppl 6), pp s348-s349, 1991.
  • Pedro H. A. Eerdmans, Harry A. J. Struyker Boudier and Jo G. R. De Mey. Effect of nerve stimulation on isolated mesenteric and intra-renal resistance arteries, shr versus wky. Genetic Hypertension. Ed. J. Sassard, pp 85-87, 1992.
  • Harrie C.M. boonen, Mat J.A.P. Daemen, Pedro H.A. Eerdmans, Gregorio E. Fazzi, Ellen M. van Kleef, Paul M. H. Schiffers, and Jo G.R. De Mey. Mesenteric small artery changes after vasocontrictor infusion in young rats. Journal of Cardiovascular Pharmacology, 22, pp 388-395, 1993.
  • K. Bulstra, R. Kuijer, P. Eerdmans, A.J. van der Linden. The effect in vitro of irrigating solutions on intact rat articular cartilage. Journal of Bone and Joint Surgery. 76-B, 468-470, 1994.
  • Ben J.A. Janssen, Pedro H.A. Eerdmans, Jos F.M. Smits. Mechanisms of renal vasoconstriction following furosemide in conscious rats. Naunyn-Schmiedeberg’s Arch Pharmacol, 349, 528-537, 1994.
  • Pedro H.A. Eerdmans, Maike C.J. Persoons, Sjaak J. M. Debets, Harry A.J. Struijker Boudier, Jos F.M. Smits, Catrien A. Bruggeman, Jo G.R. De Mey. Impaired arterial reactivity following cytomegalovirus Infection in the immunosuppressed rat. British journal of Pharmacology, 119, 637-646, 1996
  • H.J. Weil, R.A. Janknegt, P.H.A. Eerdmans. Cursusboek PAOG, Cursus “Incontinentie & urodynamisch onderzoek bij de vrouw” 14 en 15 november, pp 112-117, 1996
  • A. Janknegt, E.H.J. Weil, P.H.A. Eerdmans. Improving neuromodulation technique for refractory voiding dysfunctions: Two stage implant.
  • Urology 49 (3), pp 358-362, 1997
  • Thesis: Sympathetic nerves and alterations in vascular structure and reactivity (ISBN 90-9010188-88) total 208 pages. 1997.
  • H.J. Weil, P.H.A. Eerdmans, G.A. Dijkman, K. Tamussino, J. Feyereisl, M.E. Vierhout, C. Schmidbauer, C. Egarter, D. Kölle, J.E. Plasman, H. Heidler, B.E. Abbühl, W. Wein. Randomised, double-blind, placebo-controlled, multicentre evaluation of efficacy and dose-finding of midodrine hydrochloride in women with mild to moderate stress urinary incontinence – a phase II study. International Urogynecology Journal, 9 pp 145-50, 1998
  • H.J. Weil, P.H.A. Eerdmans, P.E.V. Van Kerrebroeck. La neuromodulazione per disfunzioni vescicali. Ginecologica Urologica, Cic edizioni internazionali, ISBN 88-7141-322-9, pp 275-278, 1998
  • Weil EH, Ruiz-Cerda JL, Eerdmans PH, Janknegt RA, Van Kerrebroeck PE. Clinical results of sacral neuromodulation for chronic voiding dysfunction using unilateral sacral foramen electrodes. World Journal of Urology.16(5):313-21,1998
  • Weil EHJ, Ruiz-Cerdá JL, Eerdmans PHA, Janknegt RA, Bemelmans BLH, van Kerrebroeck PEV. Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomized clinical trial. European Journal of Urology; 37: 161–71, 2000
  • Stephan Windecker, Patrick W Serruys, Simon Wandel, Pawel Buszman, Stanislaw Trznadel, Axel Linke, Karsten Lenk, Thomas Ischinger,Volker Klauss, Franz Eberli, Roberto Corti, William Wijns, Marie-Claude Morice, Carlo di Mario, Simon Davies, Robert-Jan van Geuns, Pedro Eerdmans, Gerrit-Anne van Es, Bernhard Meier, Peter Jüni. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomized non-inferiority trial. The Lancet; September 1, 2008 DOI:10.1016/S0140-6736(08)61244-1
  • Peter Barlis, Evelyn Regar, Patrick W. Serruys, Konstantinos Dimopoulos, Willem J. van der Giessen, Robert-Jan M. van Geuns, Giuseppe Ferrante, Simon Wandel, Stephan Windecker, Gerrit-Anne van Es, Pedro Eerdmans, Peter Jüni and Carlo di Mario. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. European Heart Journal 2010 31(2):165-176; doi:10.1093 /eurheartj/ehp480
  • Giovanna Sarno, Scot Garg, Yoshinobu Onuma, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz Eberli, Roberto Corti, William Wijns, Marie-Claude Morice, Carlo di Mario, Robert Jan van Geuns, Pedro Eerdmans, Hector M. Garcia-Garcia, Gerrit-Anne van Es, Dick Goedhart, Ton de Vries, Peter Jüni, Bernhard Meier, Stephan Windecker, Patrick Serruys. The Impact of Body Mass Index on the One Year Outcomes of Patients Treated by Percutaneous Coronary Intervention With Biolimus- and Sirolimus-Eluting Stents (from the LEADERS Trial). American Journal of Cardiology ,DOI: 10.1016/j.amjcard. 2009.09.05
  • Garg S, Wykrzykowska J,De Vries T, Simon W, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Conti R,Wijns W, Morice M-C, Di Mario C, Davis Svan Geuns R, Eerdmans P, Van Es G-A, Meier B,Juni P, Windecker S, Serruys PW. The outcome of bifurcation lesion stenting using a biolimus eluting stent with a biodegradable polymer compared to a sirolimus eluting stent with a durable polymer. EuroIntervention :.Volume 5, Supplement E, May 2009
  • Garg Scot, Sarno Giovanna, Serruys Patrick, De Vries T, Buszman , Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice M-C, Di Mario C, van Geuns RJ, Eerdmans P, Van Es G-A, Meier B, Jüni P, Windecker. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 2010;6(2):233-9
  • Giulio G Stefanini MD, Bindu Kalesan MSc, Prof Patrick W Serruys MD, Dik Heg PhD, Prof Pawel Buszman MD, Prof Axel Linke MD, Prof Thomas Ischinger MD, Prof Volker Klauss MD, Prof Franz Eberli MD, William Wijns MD, Marie-Claude Morice MD, Prof Carlo Di Mario MD,Roberto Corti MD, Diethmar Antoni MD, Hae Y Sohn MD, Pedro Eerdmans PhD, Gerrit-Anne van Es PhD, Prof Bernhard Meier MD, Prof Stephan Windecker MD, Prof Peter Jüni MD. Long-Term Clinical Outcomes of Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Sirolimus-Eluting Stents in Patients with Coronary Artery Disease (LEADERS): 4 Year Follow-up of a Randomised Non-Inferiority Trial. The Lancet  2011; 378: 1940-1948
  • Patrick W. Serruys, MD, PhD; Vasim Farooq, MB, ChB; Bindu Kalesan, PhD, MPH; Ton de Vries, MSc; Pawel Buszman, MD, PhD; Axel Linke, MD; Thomas Ischinger, MD; Volker Klauss, MD; Franz Eberli, MD; William Wijns, MD, PhD; Marie Claude Morice, MD; Carlo Di Mario, MD, PhD; Roberto Corti, MD; Diethmar Antoni, MD; Hae Y. Sohn, MD; Pedro Eerdmans, MD, PhD; Tessa Rademaker-Havinga, MSc; Gerrit-Anne van Es, PhD; Bernhard Meier, MD, PhD; Peter Jüni, MD; Stephan Windecker, MD. Improved Safety and Reduction in Stent Thrombosis Associated With Biodegradable Polymer-Based Biolimus-Eluting Stents Versus Durable Polymer-Based Sirolimus-Eluting Stents in Patients With Coronary Artery DiseaseFinal 5-Year Report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) Randomized, Noninferiority Trial. J Am Coll Cardiol Intv. 2013;6(8):777-789. doi:10.1016/j.jcin.2013.04.011
  • Yao-Jun Zhang, Javaid Iqbal, Stephan Windecker, Axel Linke, Diethmar Antoni,Hae Young Sohn, Roberto Corti, Gerrit-Anne van Es, Samuel Copt, Pedro Eerdmans, Rana Saitta, Marie-Claude Morice, Carlo Di Mario, Peter Juni, William Wijns,Pawel Buszman, Patrick W Serruys. Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart heartjnl-2014-306359 Published Online First: 25 November 2014
  • Philip Urban, Mariano Valdés, Ian Menown, Franz Eberli, Imad Alhaddad, David Hildick-Smith, David Iosseliani, Marco Roffi, Keith Oldroyd, Erifyli Kalloudi, Pedro Eerdmans, Jacques Berland, Franz Xaver Kleber, Outcomes following implantation of the biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry. Catheter Cardiovasc Interv 2015 Feb 12. Epub 2015 Feb 12.
  • -Philip Urban, Roxana Mehran, Roisin Colleran,. Pedro Eerdmans and more. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. European Heart Journal, ehz372, https://doi.org/10.1093/eurheartj/ehz372, 22 May 2019
  • Davide Capodanno MD, PhD, Marie-Claude Morice MD, Pedro Eerdmans and more.Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel. Journal of the American College of Cardiology 76(12):1468-1483, DOI: 10.1016/j.jacc.2020.06.085