A. Kaplan

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Medical Device Development: From Prototype to Regulatory Approval

Michael Simons, Martin B Leon, Thomas J Fogarty, 2004, Circulation.

Correlation of invasive Doppler flow wire with renal duplex ultrasonography in the evaluation of renal artery stenosis: the Renal Artery Stenosis Invasive Doppler (RAIDER) study.

Craig A. Thompson, J. Robb, T. Mackenzie, 2007, Journal of vascular surgery.

Post–Market Approval Surveillance: A Call for a More Integrated and Comprehensive Approach

M. Leon, D. Baim, R. Mehran, 2004, Circulation.

A novel nucleotide-based thrombin inhibitor inhibits clot-bound thrombin and reduces arterial platelet thrombus formation.

Wei-xing Li, J. Toole, L. Leung, 1994, Blood.

Roles of Thrombin and Platelet Membrane Glycoprotein IIb/IIIa in Platelet‐Subendothelial Deposition After Angioplasty in an Ex Vivo Whole Artery Model

I. Mcdougall, L. Leung, A. Kaplan, 1991, Circulation.

Tryton I, First-In-Man (FIM) study: six month clinical and angiographic outcome, analysis with new quantitative coronary angiography dedicated for bifurcation lesions.

P. Serruys, S. Ramcharitar, R. V. van Geuns, 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device

W. Gray, A. Kaplan, R. Sommer, 2021, BioMed research international.

Medical device development: Managing conflicts of interest encountered by physicians

D. Baim, A. Kaplan, D. Feigal, 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Classification and treatment of coronary artery bifurcation lesions: putting the Medina classification to the test.

Jeremiah R. Brown, Vijay S. Ramanath, A. Kaplan, 2012, Cardiovascular revascularization medicine : including molecular interventions.

Outcomes following coronary stenting in the era of bare-metal vs the era of drug-eluting stents.

J. Skinner, F. Lucas, D. Malenka, 2008, JAMA.

PFO closure for prevention of recurrent stroke in patients after cryptogenic stroke: The imperative of completing randomized controlled trials

J. Robb, A. Kaplan, T. Lukovits, 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

The impact of hematocrit drop on long‐term survival after cardiac catheterization: Insights from the Dartmouth Dynamic Registry

Craig A. Thompson, Jeremiah R. Brown, J. Jayne, 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Funding of Studies Supporting IA Guideline Recommendations in Cardiovascular Medicine—A Systematic Review

Emily P. Zeitler, A. Kaplan, L. Cooper, 2021, Journal of the American Heart Association.

Trans-Mitral Gradient Assessment Using a Radial Coronary Catheter and Pressure-Wire. First Clinical Report

A. Delago, J. Jayne, A. Kaplan, 2022, Journal of the Society for Cardiovascular Angiography & Interventions.

Renovascular disease in patients with coronary artery disease

A. Kaplan, Michael H Duong, C. Thompson, 2005 .

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use.

W. Gray, L. Sugeng, M. Szerlip, 2021, JACC. Cardiovascular interventions.

Challenges and innovations in coronary bifurcation stenting: the Tryton™ side-branch stent

D. Trabattoni, A. Kaplan, A. Bartorelli, 2010 .

A novel nucleotide-based thrombin inhibitor inhibits clot-bound thrombin and reduces arterial platelet thrombus formation

Wei-xing Li, J. Toole, L. Leung, 1994 .

Transient and persistent renal dysfunction are predictors of survival after percutaneous coronary intervention: Insights from the Dartmouth Dynamic Registry

Jeremiah R. Brown, J. Jayne, D. Malenka, 2008, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Local delivery of heparin post‐PTCA: A multicenter randomized pilot study

M. Krucoff, W. Cantor, J. Tcheng, 2000, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Real World Application of Stenting of Unprotected Left Main Coronary Stenosis: A Single-Center Experience

Jeremiah R. Brown, J. Jayne, D. Malenka, 2010, Cardiology research.

Gender‐based differences of percutaneous coronary intervention in the drug‐eluting stent era

J. Jayne, N. Niles, B. Friedman, 2006, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Unintended consequences in a quickly evolving world

A. Kaplan, 2005, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Intramural delivery of agent via a novel drug-delivery sleeve. Histological and functional evaluation.

P. Yock, Á. Moura, J. Lam, 1995, Circulation.

Postmarketing surveillance of medical devices using Medicare claims.

D. Malenka, J. Wennberg, S. Sharp, 2005, Health affairs.

Visual estimation versus different quantitative coronary angiography methods to assess lesion severity in bifurcation lesions

P. Serruys, J. Tijssen, R. D. de Winter, 2018, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Medical device regulatory landscape: the imperative of finding balance.

David O. Williams, A. Kaplan, 2012, Circulation. Cardiovascular interventions.

Outcomes of diabetics receiving bare‐metal stents versus drug‐eluting stents

Jeremiah R. Brown, J. Jayne, D. Malenka, 2010, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

From Prototype to Regulatory Approval

M. Leon, D. Baim, R. Kuntz, 2004 .

Retrograde techniques and the impact of operator volume on percutaneous intervention for coronary chronic total occlusions an early U.S. experience.

J. Jayne, N. Niles, W. Lombardi, 2009, JACC. Cardiovascular interventions.

Coronary Bifurcation Lesions

A. Kaplan, James T. DeVries, 2014 .

Assessment with optical coherence tomography of a new strategy for bifurcational lesion treatment: The Tryton Side‐Branch Stent

C. Di Mario, A. Kaplan, G. Ferrante, 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Tryton side-branch stent.

A. Kaplan, H. R. Davis, 2006, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

Serial intravascular ultrasound analysis of complex bifurcation coronary lesions treated with the tryton bifurcation stent in conjunction with an everolimus‐eluting stent: IUVANT (Intravascular ultrasound evaluation of tryton stent) study

G. Mintz, J. Popma, A. Maehara, 2015, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Heparin delivery at the site of angioplasty with a novel drug delivery sleeve.

M. Hofmann, J. Simpson, A. Kaplan, 1996, The American journal of cardiology.

The Impact of the Medical Device Directive to Medical Device Regulation Transition on Early Clinical Testing of Cardiovascular Devices

Emily P. Zeitler, A. Kaplan, Adam J. Prince, 2022, Journal of the Society for Cardiovascular Angiography & Interventions.

Regulatory strategies for early device development and approval

M. Mack, D. Holmes, A. Kaplan, 2022, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Early Feasibility Studies in Evolution.

A. Farb, D. Holmes, M. Mack, 2021, Journal of the American College of Cardiology.

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

M. Mack, Bram D. Zuckerman, M. Leon, 2020, Journal of the American College of Cardiology.

The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?

M. Mack, Bram D. Zuckerman, M. Leon, 2018, JACC. Cardiovascular interventions.

The Central and Unacknowledged Role of the US Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

A. Stern, A. Kaplan, 2017, JAMA cardiology.

Percutaneous coronary intervention treatment of bifurcation lesions--a work in progress: the importance of single-center studies.

A. Kaplan, 2009, JACC. Cardiovascular interventions.

Double barrel stenting of the left main: Proceed with caution

A. Kaplan, 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

The Medical Device Innovation Consortium and Its Goal to Further the Efficiency of Early Feasibility Studies in the United States

M. Mack, M. Leon, D. Holmes, 2019, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study.

G. Ayele, M. Leon, D. Cutlip, 2016, JACC. Cardiovascular interventions.

Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions InvolvingLarge Side Branches

G. Ayele, M. Leon, D. Cutlip, 2016 .

Extent and distribution of in-stent intimal hyperplasia and edge effect in a non-radiation stent population.

N. Weissman, R. Wilensky, M. Leon, 2001, The American journal of cardiology.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study

P. Serruys, J. Wykrzykowska, P. Stella, 2016, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Percutaneous coronary intervention in two occluded arms of a saphenous ‘Y’‐graft: The importance of protecting both of your arms

A. Kaplan, Michael H Duong, R. Chan, 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Foam-based Left Atrial Appendage Closure (CLAAS) Device: Evaluation in a Chronic Canine Model

W. Gray, A. Kaplan, R. Sommer, 2022, Journal of the Society for Cardiovascular Angiography & Interventions.

Postmortem in situ micro‐ct evaluation of coronary stent fracture

A. Kaplan, J. Foerst, Timothy C. Ball, 2010, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

HS3ST1 genotype regulates antithrombin's inflammomodulatory tone and associates with atherosclerosis.

Scott M. Williams, M. Cole, F. Sellke, 2017, Matrix biology : journal of the International Society for Matrix Biology.

Spontaneous Closure of a Secundum Atrial Septal Defect.

A. Kaplan, A. Elfenbein, Terrence D. Welch, 2018, Methodist DeBakey cardiovascular journal.

Impact and temporal trends of percutaneous coronary intervention in the drug-eluting stent versus bare metal stent eras.

J. Jayne, N. Niles, B. Friedman, 2005, The American journal of cardiology.

Heparin infusion prior to stenting (HIPS) trial: final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia.

R. Wilensky, M. Leon, S. Bailey, 2000, American heart journal.

A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions.

P. Serruys, J. Wykrzykowska, P. Stella, 2015, Journal of the American College of Cardiology.

Local heparin delivery prior to coronary stent implantation: acute and six-month clinical and angiographic results.

N. D. De Cesare, A. Kaplan, A. Bartorelli, 1997, Catheterization and cardiovascular diagnosis.

Novel perfusion sleeve for use during balloon angioplasty: initial clinical experience.

A. Kaplan, C. Cannan, D. Williams, 1998, Catheterization and cardiovascular diagnosis.

How should I treat a patient with life-threatening gastrointestinal bleeding early after coronary drug-eluting stent implantation?

J. Jayne, R. de Franchis, D. Trabattoni, 2013, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

Three‐two‐one?

A. Kaplan, 2003, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Evolving strategies for the treatment of valvular heart disease: Preclinical and clinical pathways for percutaneous aortic valve replacement

B. Lyons, M. Leon, J. Fann, 2008, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Interaction of gender and age on post cardiac catheterization contrast-induced acute kidney injury.

Jeremiah R. Brown, J. Jayne, N. Niles, 2008, American Journal of Cardiology.

The complementary role of microCT and histopathology in characterizing the natural history of stented arteries

R. Virmani, M. Vorpahl, M. Kelm, 2011, Expert review of cardiovascular therapy.

Segmental comparison between a dedicated bifurcation stent and balloon angioplasty using intravascular ultrasound and three‐dimensional quantitative coronary angiography: A subgroup analysis of the Tryton IDE randomized trial

P. Serruys, R. D. de Winter, J. Wykrzykowska, 2017, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Serial intravascular ultrasound observations from the Tryton first-in-man study.

P. Serruys, G. Mintz, R. V. van Geuns, 2014, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

The evaluation of creatinine clearance, estimated glomerular filtration rate and serum creatinine in predicting contrast-induced acute kidney injury among patients undergoing percutaneous coronary intervention.

Jeremiah R. Brown, J. Jayne, D. Malenka, 2009, Cardiovascular revascularization medicine : including molecular interventions.

Classification and atherosclerosis distribution in patients with left main coronary disease.

Jeremiah R. Brown, J. Jayne, D. Malenka, 2009, Journal of interventional cardiology.

Late complication: Xience V stent fractures with restenosis.

R. Virmani, M. Nakano, A. Kaplan, 2012, JACC. Cardiovascular interventions.

Does Safe Dosing of Iodinated Contrast Prevent Contrast-Induced Acute Kidney Injury?

Jeremiah R. Brown, D. Malenka, J. Robb, 2010, Circulation. Cardiovascular interventions.

Optical coherence tomography versus intravascular ultrasound in the evaluation of observer variability and reliability in the assessment of stent deployment: The OCTIVUS study

Hector M Garcia-Garcia, J. Tijssen, J. Jayne, 2015, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Tryton I, First-In-Man (FIM) Study: acute and 30 day outcome.A preliminary report.

P. Serruys, S. Ramcharitar, M. Morice, 2007, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

Dofetilide-Associated QT Prolongation: Total Body Weight Versus Adjusted or Ideal Body Weight for Dosing

Rajbir S Sangha, A. Kaplan, Terrence D. Welch, 2018, Journal of cardiovascular pharmacology.

Postmarket surveillance for drug-eluting coronary stents: a comprehensive approach.

T. Gross, D. Malenka, D. Baim, 2006, Circulation.

Age-based differences of percutaneous coronary intervention in the drug-eluting stent era.

J. Jayne, N. Niles, K. C. Floyd, 2006, Journal of interventional cardiology.

Redefining the Prognostic Value of High-Sensitivity Troponin in COVID-19 Patients: The Importance of Concomitant Coronary Artery Disease

F. Fedele, A. Giacomelli, S. Antinori, 2020, Journal of clinical medicine.

Acceleration of Cardiovascular Disease by a Dysfunctional Prostacyclin Receptor Mutation: Potential Implications for Cyclooxygenase-2 Inhibition

E. Rimm, J. Robb, F. Asselbergs, 2008, Circulation research.

Local intramural heparin delivery during primary angioplasty for myocardial infarction: Results of the local PAMI pilot study

C. Grines, Jack L. Martin, M. Ayres, 1999, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Real world, long-term outcomes comparison between paclitaxel-eluting and sirolimus-eluting stent platforms.

Jeremiah R. Brown, J. Jayne, D. Malenka, 2010, Journal of interventional cardiology.

Burn it, stitch it, plug it… there are many ways to close a PFO: Insights into the challenges of medical device development

A. Kaplan, 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

Navigating conflicts of interest for the medical device entrepreneur.

A. Kaplan, Aine O. Donovan, 2012, Progress in cardiovascular diseases.

Humanitarian Use Devices/Humanitarian Device Exemptions in cardiovascular medicine.

J. Robb, R. Kuntz, A. Kaplan, 2005, Circulation.

Widespread Coronary Aneurysm Formation Due to Hypereosinophilic Vasculitis

J. Jayne, Christopher Lee, A. Kaplan, 2023, Annals of Internal Medicine: Clinical Cases.

Classification and treatment of coronary artery bifurcation lesions: putting the Medina classification to the test.

Jeremiah R. Brown, Vijay S. Ramanath, A. Kaplan, 2012, Cardiovascular revascularization medicine : including molecular interventions.

A radiolabeled staphylococcal protein A assay for detection of anti-erythrocyte IgG in warm agglutinin autoimmune hemolytic anemia of dogs and man.

F. Quimby, A. Kaplan, 1983, Veterinary immunology and immunopathology.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study

P. Serruys, J. Wykrzykowska, P. Stella, 2016, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.