Design and Discovery of Resorbable Polymers for Coronary Stents

Size: px
Start display at page:

Download "Design and Discovery of Resorbable Polymers for Coronary Stents"

Transcription

1 Design and Discovery of Resorbable Polymers for Coronary Stents Presented at Polymers in Medicine and Biology 2013 Joachim Kohn Director New Jersey Center for Biomaterials Rutgers University Piscataway, New Jersey

2 Overview This lecture covers the early history of stent development up to the first deployable prototype, focusing on polymer design principles The following lecture by Dr Zeltinger focuses on the clinical experience and recent data Disclosure: Joachim Kohn is a consultant for REVA and has a financial interest in REVA

3 Percutaneous Transluminal Coronary Angioplasty (PTCA)

4 Resorbable or permanent? The very early thoughts about preventing restenosis after angioplasty indicated that a temporary support device was needed to keep the injured blood vessel open The Kohn Lab submits a research proposal on developing new polymers for resorbable stents in 1988 (and doesn t get funded) For lack of any other options, the first clinically used stents were permanently implanted metal stents.

5 Progression of Stent Development Metal stents 93 Palmaz-Schatz stent FDA approved for coronary use Antiplatelet or anticoagulant coated metal stents 00 Phosphorylcholine coated and heparin coated stents FDA approved Resorbable polymeric stents 00 Tamai et al. first to implant resorbable PLLA coronary stents in humans using a heated balloon technique Anti-restenosis drug-eluting, coated stents 03 CYPHER Sirolimus-eluting coronary stent FDA approved 2006 Abbott introduces Absorb, a drug eluting bioresorbable vascular scaffold (BVS) made of PLLA 2007 REVA Medical announces trials of its resorbable, radioopaque, drug eluting vascular scaffold made of a new X-ray visible polycarbonate

6 Early Resorbable stents - Examples Stack et al. 88 Poly(L-lactic acid) stent Yoklavich et al. 96 PLA/TMC stent by J&J Cordis molded by Tesco Assoc. Tamai et al. 00 Zigzag helical coil Poly(L-lactic acid) Deployed in humans Biosensors and Guidant Prototype Self-Expanding Stent

7 Why is it so difficult to design a polymer stent that matches the performance of metal stents Polymer Properties Not usually radio-opaque Low strength & stiffness Poor flexibility Difficult to deform rapidly without damage Tends to creep under continuous load Physical aging and crystallization during storage Metal Properties Radio-opaque High strength and stiffness High flexibility Easily deformable Creep resistant Storage stability

8 Why is it so difficult to design a polymer stent that matches the performance of metal stents Polymer Properties Not usually radio-opaque Low strength & stiffness Poor flexibility Difficult to deform rapidly without damage Tends to creep under continuous load Physical aging and crystallization during storage Target Polymer Properties Incorporate iodine Poly(BPA carbonate) Redesign the stent Redesign the stent High Tg, strong interchain interactions Amorphous, high Tg

9 Tyrosine-derived monomers are building blocks for resorbable biomaterials CH 3 HO C OH CH 3 Bisphenol A (BPA) HO I CH 2 CH 2 O C NH CH CH 2 OH I C O O Non-toxic monomer system Polymer libraries of polyarylates, triblock copolymers, polycarbonates Tyrosine-derived polymers degrade exclusively into metabolites, nutrients and components that are classified as GRAS by the FDA R

10 Increasing the design flexibility The original REVA stent polymers were terpolymers of iodinated DTR, DT, and PEG

11 Unprecedented freedom in the design of an optimized stent material Pendant Chain E,B,H, O etc Carboxylate (DT) Iodination PEG Cell Adhesion Resorption Visibility Stiffness Stiffness Stiffness Stiffness Cell Adhesion Tyrosine-derived polycarbonates allow for the efficient modification of polymer properties

12 The problem of design complexity Poly(glycolic acid) Design parameters: molecular weight molecular weight distribution annealing/crystallinity A simple design of about 20 experiments is sufficient to explore the design space of poly(glycolic acid) Poly(x%DTR-co-y%DT-co-z %PEG MW carbonate) Design parameters: overall polymer composition random vs block architecture PEG molecular weight DTR pendent chain A library of over 10,000 discreet compositions, each one with potentially useful, individual properties It is no longer possible to synthesize all potential compositions explore all potential composition

13 Combinatorial-Computational Approach Kohn, J., W.J. Welsh, and D. Knight., Biomaterials, (29): p "

14 We can make hundreds of polymers Automated Parallel Synthesis Station up to 192 parallel reactions substantial flexibility in the design of workflows shared user facility is open to potential collaborators

15 Rapid Screening Immuno-Fluorescence-Assay to detect adsorbed fibrinogen as a screen for thrombogenicity Procedure Coat microwells with polymers Incubate with a single protein solution Detect adsorbed protein with fluorescently labeled antibody Compare the fluorescence signals for multiple polymers within one plate 384- well plate

16 Screening for fibrinogen adsorption fluorescence signal (% of control) Polymer The screening of 44 polymers with at least 16 repetitive measurements per polymer (704 data points) can be conveniently achieved in two plates and required only about 2 hours of technician work time.!

17 Gene Expression of Pro-Inflammatory Cytokines as a screening test for inflammation IL-1 beta expression polymer Variation in IL-1beta expression in peritoneal rat macrophages in contact with 72 different polymer surfaces

18 Effect of PEG on protein adsorption and cell attachment (fibroblasts) Adsorbed FN (µg/cm?) Data Linear Fit R 2 = Cell Attachment (%) * * * PEG Content (%) PEG Content (%) Protein adsorption (Fibronectin) on surfaces of poly(dte-co-peg carbonate) is reduced by inclusion of PEG Total cell number decreases significantly when the amount of PEG in the polymer reaches 6 Mol%.

19 Artificial Neural Network (ANN) Input Input Input Input Input Input Input Input Input Any measured parameter or observation Hidden Layer A set of weighed linear regressions or other functions Output Prediction of the model The ANN needs a training set of data to determine the optimum value of the weighing functions in the hidden layer that lead to the closest match between an experimentally determined outcome and the prediction of the model. Thereafter the ANN can make empirical predictions of the outcome when presented with similar data sets.

20 Computational Models to Predict Protein Adsorption and Cell Growth 48 polymer" were prepared" 24 polymers" were explored" 24 polymers" were never tested" Experimental data were used to train" the computer models" These data were used as inputs to predict protein adsorption and cell growth"

21 Prediction of the Glass Transition Tg (deg C) measured predicted polymer number (arbitrary)

22 Prediction of Fibrinogen Adsorption measured predicted Polymer (arbitrary number)

23 Prediction of Normalized Metabolic Activity (NMA) for rat lung fibroblasts measured predicted Polymer (arbitrary number)

24 Combinatorial-computational method Advantages Relatively simple Relatively cheap Relatively effective for exploring a limited range of properties Disadvantages Requires a training set, e.g., polymers still have to be synthesized and experimental data must be collected Accuracy of the predictions depends on the quality of the experimental data Predictions are only made for specific polymers classes and are not generalizable to other polymer structures

25 Summary: Acceleration of the pace of development The process started with the identification of desirable polymer properties by the customer, a stent company Searching within a library space of over 10,000 possible compositions, a polymer with suitable properties relating to DEGRADATION, MECHANICAL STENGTH, HEMOCOMPATIBILITY, and X RAY VISIBILITY was found, synthesized and tested within about 1 year The combinatorially designed material performed as predicted. A fully deployable stent could be fabricated upon first trial Visibility by fluoroscopy of the polymer stent (top) and a market leading steel stent (bottom) Hemocompatibility in the pig coronary model: 3 weeks post implantation, there was no evidence for necrosis, inflammation, thrombosis or restenosis.

26 The initial stent prototype could be deployed (*) Note: This is a historic image, dating back to This is not representative of the current REVA stent design.

27 Why is the development of a degradable polymer stent a significant challenge? Polymers lack strength compared to metals, requiring significant optimization of composition and processing Many common polymer properties are incompatible with stent requirements, requiring device design work-arounds : Rapid deformation Device flexibility Extremely thin struts Radio-opacity Vascular tissue compatibility and very benign degradation products to minimize inflammation-mediated restenosis Processibility

28 Thank you!

Evolution of Intravascular Technology for Coronary Artery Disease Treatment

Evolution of Intravascular Technology for Coronary Artery Disease Treatment Evolution of Intravascular Technology for Coronary Artery Disease Treatment Yunbing Wang Nadine Ding, James Oberhauser Thierry Glauser, Xiao Ma, Derek Mortisen Bioabsorbable Vascular Solutions (BVS) Abbott

More information

Company Update. 28 May REVA Medical, Inc.

Company Update. 28 May REVA Medical, Inc. Company Update 28 May 2015 6 Recent Milestones Q2 through Q4 2014 Developed Fantom (to offer the desired advancements for a second generation product) November 2014 Completed $25 million financing (warrants

More information

For personal use only

For personal use only Presentations at CRT Conference San Diego, California and Sydney, Australia (Tuesday, 24 February 2015, AEDT) REVA Medical, Inc. (ASX: RVA) ( REVA or the Company ) is pleased to announce that Dr. Alexandre

More information

Bioresorbable Scaffold Program Update. Alexandre Abizaid, MD, PhD, FACC Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil

Bioresorbable Scaffold Program Update. Alexandre Abizaid, MD, PhD, FACC Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil Bioresorbable Scaffold Program Update Alexandre Abizaid, MD, PhD, FACC Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil Disclosure Statement of Financial Interest Within the past 12 months, I

More information

Tyrocore: a proprietary polymer uniquely designed for vascular scaffolds

Tyrocore: a proprietary polymer uniquely designed for vascular scaffolds Tyrocore: a proprietary polymer uniquely designed for vascular scaffolds PD Dr. med Gregor Leibundgut Medizinische Universitätsklinik Kantonsspital Baselland Liestal, Switzerland 1 Potential conflicts

More information

Testimony of Joachim Kohn, Ph.D Board of Governors Professor of Chemistry and Chemical Biology Rutgers, the State University of New Jersey.

Testimony of Joachim Kohn, Ph.D Board of Governors Professor of Chemistry and Chemical Biology Rutgers, the State University of New Jersey. Testimony of Joachim Kohn, Ph.D Board of Governors Professor of Chemistry and Chemical Biology Rutgers, the State University of New Jersey Before the Subcommittee on Health of the Committee on Energy and

More information

REVA s Bioresorbable Scaffold Program Update. Alexandre Abizaid, MD, PhD, FACC Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil

REVA s Bioresorbable Scaffold Program Update. Alexandre Abizaid, MD, PhD, FACC Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil REVA s Bioresorbable Scaffold Program Update Alexandre Abizaid, MD, PhD, FACC Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil REVA s Technology Transition to the Fantom Scaffold 2011: ReZolve

More information

The Next Generation of Stents for the Lower Extremity: What s on the Horizon?

The Next Generation of Stents for the Lower Extremity: What s on the Horizon? The Next Generation of Stents for the Lower Extremity: What s on the Horizon? PNEC 2017 Pacific Northwest Vascular Conference Thursday, May 25, 2017 Seattle, WA Brian DeRubertis, MD, FACS Associate Professor

More information

Bioresorbable Stent Implantation for Tibial Disease

Bioresorbable Stent Implantation for Tibial Disease Bioresorbable Stent Implantation for Tibial Disease Leipzig Interventional Course January 24-27, 2017 Leipzig, Germany Brian DeRubertis, MD, FACS Associate Professor of Surgery Division of Vascular & Endovascular

More information

Bioabsorbable Stents. The Ideal Scaffold properties and kinetics. Jonathan Hill King s College Hospital King s Health Partners

Bioabsorbable Stents. The Ideal Scaffold properties and kinetics. Jonathan Hill King s College Hospital King s Health Partners Bioabsorbable Stents The Ideal Scaffold properties and kinetics Jonathan Hill King s College Hospital King s Health Partners Transient Biodegradable Scaffold Building a skyscraper in Hong Kong with bamboo

More information

For personal use only

For personal use only REVA MEDICAL PRESENTS KEY DATA SETS AT THE TRANSCATHETER CARDIOVASCULAR THERAPEUTICS CONFERENCE 2018 Sydney, Australia and San Diego, California (Monday, 24 September 2018 - AEST) REVA Medical, Inc. (ASX:

More information

President St. Joseph s Heart and Vascular Institute Professor of Medicine Emeritus Emory University

President St. Joseph s Heart and Vascular Institute Professor of Medicine Emeritus Emory University President St. Joseph s Heart and Vascular Institute Professor of Medicine Emeritus Emory University Serruys PW. et al. EuroIntervention. 2010; 6; 195-205 2. Histomorphometry and histopathology at 90

More information

Dr. Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil

Dr. Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil FANTOM II: Six Month Clinical and Angiographic Results With a Radiopaque Desaminotyrosine Polycarbonate Based Sirolimus Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease

More information

Abbott Vascular Inc. - Product Pipeline Analysis, 2016 Update

Abbott Vascular Inc. - Product Pipeline Analysis, 2016 Update Abbott Vascular Inc. - Product Pipeline Analysis, 2016 Update Abbott Vascular Inc. - Product Pipeline Analysis, 2016 Update BioPortfolio has been marketing business and market research reports from selected

More information

Fantom: A Radio-Opaque Stent-Like BRS With Improved Expansion Characteristics

Fantom: A Radio-Opaque Stent-Like BRS With Improved Expansion Characteristics DIDACTIC SESSION: BIORESORBABLE VASCULAR SCAFFOLDS, PART 1 - DEVICES AND EMERGING DATA Session III. Next Generation Scaffolds Part 1: Design Iterations, Data, and Clinical Development Colorado Convention

More information

Empowering innovation.

Empowering innovation. Empowering innovation. RESOMER is a synonym for innovation and vision, enabling both pharma and medical device companies to shape and design a better future. 30 years of RESOMER The history of RESOMER

More information

REVA Medical. Corporate Presentation November REVA Medical REVA Medical CC Rev. C

REVA Medical. Corporate Presentation November REVA Medical REVA Medical CC Rev. C REVA Medical Corporate Presentation November 2017 2017 REVA Medical CC100021 Rev. C 0 2017 REVA Medical. Important Notice Not an Offer for Securities This presentation does not constitute an offer, invitation,

More information

Nanodiamond-Based Therapeutic Delivery Films For the Treatment of Cancer and Inflammation

Nanodiamond-Based Therapeutic Delivery Films For the Treatment of Cancer and Inflammation Nanodiamond-Based Therapeutic Delivery Films For the Treatment of Cancer and Inflammation Dean Ho, Ph.D. Assistant Professor Departments of Biomedical and Mechanical Engineering Lurie Comprehensive Cancer

More information

Comparison of SynBiosys Urethane-linked Multi-block Copolymer and PLGA Coatings

Comparison of SynBiosys Urethane-linked Multi-block Copolymer and PLGA Coatings Comparison of SynBiosys Urethane-linked Multi-block Copolymer and PLGA Coatings Nathan Lockwood Dennis Nduli Joe Tokos Tony Anderson Robert Hergenrother SurModics, Inc. Improving patient lives through

More information

REVA Medical. Corporate Presentation January REVA Medical CC Rev. D REVA Medical.

REVA Medical. Corporate Presentation January REVA Medical CC Rev. D REVA Medical. REVA Medical Corporate Presentation January 2018 2017 REVA Medical CC100021 Rev. D 0 2017 REVA Medical. Important Notice Not an Offer for Securities This presentation does not constitute an offer, invitation,

More information

Three-Year Clinical Outcomes with Everolimus-Eluting Bioresorbable Scaffolds: Results from the Randomized ABSORB III Trial Stephen G.

Three-Year Clinical Outcomes with Everolimus-Eluting Bioresorbable Scaffolds: Results from the Randomized ABSORB III Trial Stephen G. Three-Year Clinical Outcomes with Everolimus-Eluting Bioresorbable Scaffolds: Results from the Randomized ABSORB III Trial Stephen G. Ellis MD Dean J. Kereiakes MD and Gregg W. Stone MD for the ABSORB

More information

Tissue- Biomaterial Interactions

Tissue- Biomaterial Interactions An Introduction To Tissue- Biomaterial Interactions Kay C Dee, Ph.D Tulane University Department of Biomedical Engineering New Orleans, Louisiana David A. Puleo, Ph.D University of Kentucky Center for

More information

Rationale and Design of the Prospective, Multicenter, Randomized Trial of 2 nd Generation BuMA DES in Europe

Rationale and Design of the Prospective, Multicenter, Randomized Trial of 2 nd Generation BuMA DES in Europe Rationale and Design of the Prospective, Multicenter, Randomized Trial of 2 nd Generation BuMA DES in Europe Patrick W. Serruys Marie-angele Morel Cindy Zheng Yoshinobu Onuma 13:30, March 22, 2014 Background

More information

Novel BioResorbable Vascular Platforms from India

Novel BioResorbable Vascular Platforms from India DEEP DIVE SESSION: Lower limb interventions (part II) Femoropopliteal, drug-eluting devices, and new technologies Time 11:55am to 12:01pm Novel BioResorbable Vascular Platforms from India Dr. Vimal Someshwar

More information

Immunology 101: Implications for Medical Device Failure. Joshua B. Slee, PhD Assistant Professor of Biology

Immunology 101: Implications for Medical Device Failure. Joshua B. Slee, PhD Assistant Professor of Biology Immunology 101: Implications for Medical Device Failure Joshua B. Slee, PhD Assistant Professor of Biology Learning Goals Understand innate and adaptive immunity Explain how innate and adaptive immunity

More information

UConn BMES Meeting #2 (9/28) T R A C K P R E S E N T A T I O N S

UConn BMES Meeting #2 (9/28) T R A C K P R E S E N T A T I O N S UConn BMES Meeting #2 (9/28) T R A C K P R E S E N T A T I O N S Concept of Biomedical Engineering Biomedical Engineering is an interdisciplinary application of engineering principals The major is an application

More information

Biomaterials. Third Edition

Biomaterials. Third Edition Biomaterials Third Edition Joon Park R.S. Lakes Biomaterials An Introduction Third Edition Joon Park Biomedical and Mechanical Engineering University of Iowa Iowa City, IA 52242-1414 USA joon-park@uiowa.edu

More information

W BIOENGINEERING. Nanomaterials Applications in Biology and Medicine. Topics:

W BIOENGINEERING. Nanomaterials Applications in Biology and Medicine. Topics: Nanomaterials Applications in Biology and Medicine Obejctive: Develop a firm understanding of the fundamental materials science and engineering principles underlying synthetic/engineered materials used

More information

Symposium Biotronik High-Tech DRug Eluting Absorbable Metal Stent: dreaming the future! Didier Tchétché. Clinique Pasteur.

Symposium Biotronik High-Tech DRug Eluting Absorbable Metal Stent: dreaming the future! Didier Tchétché. Clinique Pasteur. Symposium Biotronik High-Tech 2014 DRug Eluting Absorbable Metal Stent: dreaming the future! Didier Tchétché Clinique Pasteur Toulouse Key characteristics of absorbable scaffold materials Material PLLA

More information

Applications in Cardiology Hollow Fiber Membranes and Applications

Applications in Cardiology Hollow Fiber Membranes and Applications Applications in Cardiology Want is meant by the term silicones?; Describe in general terms a typical synthetic scheme for a silicone consisting of half PDMS and half polysiloxane; Describe three cross-linking

More information

Polymeric hydrogels are of special importance in polymeric biomaterials because of

Polymeric hydrogels are of special importance in polymeric biomaterials because of POLYMERIC HYDROGELS Polymeric hydrogels are of special importance in polymeric biomaterials because of their favorable biocompatibility. Hydrogels are cross-linked macromolecular networks formed by hydrophilic

More information

REVA Medical. Corporate Presentation November REVA Medical REVA Medical CC Rev. B

REVA Medical. Corporate Presentation November REVA Medical REVA Medical CC Rev. B REVA Medical Corporate Presentation November 2017 2017 REVA Medical CC100021 Rev. B 0 2017 REVA Medical. Important Notice Not an Offer for Securities This presentation does not constitute an offer, invitation,

More information

Bioabsorbable Stents - Medical Devices Pipeline Assessment, 2015

Bioabsorbable Stents - Medical Devices Pipeline Assessment, 2015 Bioabsorbable Stents - Medical Devices Pipeline Assessment, 2015 Bioabsorbable Stents - Medical Devices Pipeline Assessment, 2015 BioPortfolio has been marketing business and market research reports from

More information

Pittsburgh Tissue Engineering Initiative Annual Progress Report: 2010 Formula Grant

Pittsburgh Tissue Engineering Initiative Annual Progress Report: 2010 Formula Grant Pittsburgh Tissue Engineering Initiative Annual Progress Report: 2010 Formula Grant Reporting Period July 1, 2011 December 31, 2011 Formula Grant Overview The Pittsburgh Tissue Engineering Initiative,

More information

Cre8 TM BTK polymer-free DES technology: the Activ8 clinical trial

Cre8 TM BTK polymer-free DES technology: the Activ8 clinical trial Cre8 TM BTK polymer-free DES technology: the Activ8 clinical trial Enrico Maria Marone Vascular Surgery - - San Raffaele ScientificInstitute, Milan - Italy Disclosure Speaker name: Enrico Maria Marone

More information

Course Syllabus. BMEN 4360: Biomaterials and Medical Devices Fall Course Information

Course Syllabus. BMEN 4360: Biomaterials and Medical Devices Fall Course Information Course Syllabus Course Information Course Number/Section: BMEN 4360.001 Biomaterials and Medical Devices Term: Fall 2016 Days &Times: Class meets in JSOM 2.902 on Mondays and Wednesdays, 8:30 AM 9:45 AM

More information

Course Syllabus. BMEN 4360: Biomaterials and Medical Devices Fall Course Information

Course Syllabus. BMEN 4360: Biomaterials and Medical Devices Fall Course Information Course Syllabus Course Information Course Number/Section: BMEN 4360.001 Biomaterials and Medical Devices Term: Spring 2017 Days &Times: Class meets in ECSS 2.305 on Mondays and Wednesdays, 8:30 AM 9:45

More information

Approaching Commercialization

Approaching Commercialization Approaching Commercialization 1 2016 REVA Medical, Inc. 35th Annual J.P. Morgan Healthcare Conference January 12, 2017 Important Notice Not an Offer for Securities This presentation does not constitute

More information

White Paper: Designing Functional Fabrics for Today s Heart Valves and Beyond

White Paper: Designing Functional Fabrics for Today s Heart Valves and Beyond White Paper: Designing Functional Fabrics for Today s Heart Valves and Beyond Ryan Heniford Business Development Director Peter Gabriele Director, Emerging Technology How fabrics can be used in heart valves,

More information

For personal use only

For personal use only Positive Clinical Results for Fantom San Diego, California and Sydney, Australia (Wednesday, 18 May 2016, AEST) At the Paris Course on Revascularization ( EuroPCR ) being held this week in Paris, France,

More information

Bioabsorbable metal stents: properties, modeling and open questions

Bioabsorbable metal stents: properties, modeling and open questions Biomedical Engineering Bioabsorbable metal stents: properties, modeling and open questions Palma Tartaglione Supervisor: Prof. Ferdinando Auricchio Co-supervisor : Ing. Mauro Ferraro December 16, 2014

More information

Nanoscale Phase Separation and Water Uptake in Polymeric Biomaterials

Nanoscale Phase Separation and Water Uptake in Polymeric Biomaterials Nanoscale Phase Separation and Water Uptake in Polymeric Biomaterials Matthew R. Libera Stevens Institute of Technology Hoboken, New Jersey Triton Technology Application Note 024 Uniform water distribution

More information

Effect of CNTs on Shape memory properties of PLLA/PCL blends

Effect of CNTs on Shape memory properties of PLLA/PCL blends Effect of CNTs on Shape memory properties of PLLA/PCL blends Maryam Amirian 1, Ali Nabipour Chakoli 2, Hossein Afarideh 3, t=0s t=2s t=5s t=10s t=15s t=20s 1 Dep. of Physics, Teachers Uni., Tehran, Iran,

More information

Biocompatibility and War and Peace

Biocompatibility and War and Peace Professor David Williams, D.Sc.,F.R.Eng., Professor and Director of International Affairs, Wake Forest Institute of Regenerative Medicine, North Carolina, USA Editor-in-Chief, Biomaterials President-elect,

More information

SYNERGYTM. Everolimus-Eluting Platinum Chromium Coronary Stent System

SYNERGYTM. Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM EverolimusEluting Platinum Chromium Coronary Stent System Bioabsorbable R E D E F I N E d INTRODUCING THE SYNERGY TM EverolimusEluting Stent System featuring the innovative Synchrony TM Bioabsorbable

More information

For personal use only

For personal use only New Fantom Data Demonstrates Safety at 2 Years REVA Announces Next Generation Scaffold with 95 Micron Strut Thickness San Diego, California and Sydney, Australia (Wednesday, 1 November 2017, AEDT) The

More information

Endovascular Device Testing A Survey of Requirements for Product Validation

Endovascular Device Testing A Survey of Requirements for Product Validation MET A4 1p Endovascular Device Testing Info Sheet-02.qxp_MET A4 1p Endovascular Device Testing Info Sheet.qxp 05/04/2016 09:58 Page 1 Endovascular Device Testing A Survey of Requirements for Product Validation

More information

Biosensors International Group. 28 th Annual J.P. Morgan Healthcare Conference January 2010

Biosensors International Group. 28 th Annual J.P. Morgan Healthcare Conference January 2010 Biosensors International Group 28 th Annual J.P. Morgan Healthcare Conference January 2010 Forward Looking Statements Certain statements herein include forward-looking statements within the meaning of

More information

The Importance of Vessel Preparation

The Importance of Vessel Preparation The Importance of Vessel Preparation and How To Do It Ralf Langhoff, MD Vascular Center Sankt Gertrauden Berlin Sankt Gertrauden Hospital Charité, CC11 Academic Teaching Hospitals Charité Berlin Caution:

More information

Metallic Implants In Biomedical Engineering. Kerstin Tillmann March 2011

Metallic Implants In Biomedical Engineering. Kerstin Tillmann March 2011 Metallic Implants In Biomedical Engineering Kerstin Tillmann March 2011 Implants substitution of damaged mechanical and physical functions of the human body temporary implants and long-term implants direct

More information

ISO Cardiovascular implants Endovascular devices Part 2: Vascular stents Part 2: Vascular stent

ISO Cardiovascular implants Endovascular devices Part 2: Vascular stents Part 2: Vascular stent INTERNATIONAL STANDARD ISO 25539-2 Second edition 2012-12-01 Cardiovascular implants Endovascular devices Part 2: Vascular stents Part 2: Vascular stent Implants cardiovasculaires Dispositifs endovasculaires

More information

Engage with us on Twitter: #Molecule2Miracle

Engage with us on Twitter: #Molecule2Miracle Engage with us on Twitter: #Molecule2Miracle Kassy Perry President & CEO Perry Communications Group PhRMA Alliance Development Consultant.@kassyperry Emily Burke, Ph.D. Director of Curriculum BioTech

More information

Patrick W. Serruys, MD, PhD

Patrick W. Serruys, MD, PhD Cardiology Update 2011 The 4th revolution in percutaneous coronary revascularization: Biodegradable drug eluting scaffold Patrick W. Serruys, MD, PhD Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands

More information

Negatively charged microspheres provide an additional surface for cell attachment leading to proliferation, tissue regeneration and wound healing

Negatively charged microspheres provide an additional surface for cell attachment leading to proliferation, tissue regeneration and wound healing Negatively charged microspheres provide an additional surface for cell attachment leading to proliferation, tissue regeneration and wound healing Authors: Correa LG, Peter R, Clerici G, Ritter V. 2017

More information

Marcia L. Zucker, Ph.D. ZIVD LLC

Marcia L. Zucker, Ph.D. ZIVD LLC Marcia L. Zucker, Ph.D. ZIVD LLC 1 Explain why ACTs from different systems are not the same Develop a plan for switching from one ACT system to another Describe why ACT and aptt are not interchangeable

More information

Cell-Environment Interactions. Chieh-Chun Chen

Cell-Environment Interactions. Chieh-Chun Chen Cell-Environment Interactions Chieh-Chun Chen Part 1: Soft Lithography in Biology and Biochemistry Chieh-Chun Chen Outlines Introduction Key features of soft lithography Applications In microscopic biochemical

More information

Surface Characterization of Biomaterials

Surface Characterization of Biomaterials Surface Characterization of Biomaterials Biomaterials are determined The desire for well-being and long life expectancy goes hand in-hand with the use of non-viable materials to conserve health. 2000 years

More information

The role of polymers in drug-eluting stents

The role of polymers in drug-eluting stents review article The role of polymers in drug-eluting stents Kishore Udipi Biopolymer Designs, Inc., Santa Rosa, CA, USA Robert A Byrne Michael Joner Deutsches Herzzentrum Technische Universität, Munich,

More information

S.M.A.R.T. Our inspiration came right from the source. Feeling is believing. S.M.A.R.T. Flex Vascular Stent System. LinkedIn page

S.M.A.R.T. Our inspiration came right from the source. Feeling is believing. S.M.A.R.T. Flex Vascular Stent System. LinkedIn page to receive our latest news and key activities. S.M.A.R.T. Flex Vascular System Our inspiration came right from the source. S.M.A.R.T. Flex Vascular System Feeling is believing. LinkedIn page Follow us

More information

Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2017

Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2017 Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2017 Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2017 The Business Research Store is run by Sector Publishing Intelligence

More information

For personal use only

For personal use only AGM Presentation Sydney, Australia and San Diego, California (Thursday, 26 May 2016 AEST) REVA Medical, Inc. (ASX: RVA) ( REVA or the Company ) is pleased to provide the attached presentation that will

More information

STUDY OF STENT DEFORMATION AND STRESS DEVELOPED AT DIFFERENT STENT DEPLOYMENT PRESSURES

STUDY OF STENT DEFORMATION AND STRESS DEVELOPED AT DIFFERENT STENT DEPLOYMENT PRESSURES STUDY OF STENT DEFORMATION AND STRESS DEVELOPED AT DIFFERENT STENT DEPLOYMENT PRESSURES KRISTI BASU PRANAB GHOSH DR. ABHIJIT CHANDA SCHOOL OF BIOSCIENCE AND ENGINEERING JADAVPUR UNIVERSITY KOLKATA: 700032

More information

Reliability into. for Biomedical. Devices: Finite Elelment Analyses. Applications CAE Associates

Reliability into. for Biomedical. Devices: Finite Elelment Analyses. Applications CAE Associates Designing i Reliability into Biomedical Devices: Finite Elelment Analyses for Biomedical Applications 2005 CAE Associates Designing Reliability into Biomedical Devices: Finite Element Analyses for Bio-Medical

More information

The University of North Texas Department of Materials Science & Engineering

The University of North Texas Department of Materials Science & Engineering The University of North Texas Department of Materials Science & Engineering 2017 Spring Semester Course Title: MTSE 4020, Materials in Medicine Instructor: Narendra B. Dahotre, Office DP C136E, Phone:

More information

Present and future of regenerative medicine. Liver Transplantation

Present and future of regenerative medicine. Liver Transplantation Present and future of regenerative medicine Liver Transplantation Mireia Caralt, MD PhD Servei Cirurgia HBP i Trasplantaments March 19, 2015 Introduction Strategies to increase the number of organs EXPAND

More information

BFF1113 Engineering Materials DR. NOOR MAZNI ISMAIL FACULTY OF MANUFACTURING ENGINEERING

BFF1113 Engineering Materials DR. NOOR MAZNI ISMAIL FACULTY OF MANUFACTURING ENGINEERING BFF1113 Engineering Materials DR. NOOR MAZNI ISMAIL FACULTY OF MANUFACTURING ENGINEERING Course Guidelines: 1. Introduction to Engineering Materials 2. Bonding and Properties 3. Crystal Structures & Properties

More information

Synthetic Viruses Targeting Cancer

Synthetic Viruses Targeting Cancer Synthetic Viruses Targeting Cancer Andrew Hessel September 7, 2007 SENS 3, Cambridge, UK Why is a new strategy necessary? Breast cancer remains a significant cause of illness and death The treatment options

More information

ISO INTERNATIONAL STANDARD. Cardiovascular implants Endovascular devices Part 2: Vascular stents

ISO INTERNATIONAL STANDARD. Cardiovascular implants Endovascular devices Part 2: Vascular stents INTERNATIONAL STANDARD ISO 25539-2 First edition 2008-09-01 Cardiovascular implants Endovascular devices Part 2: Vascular stents Implants cardiovasculaires Dispositifs endovasculaires Partie 2: Endoprothèses

More information

Introduction to Drug Design and Discovery

Introduction to Drug Design and Discovery Introduction to Drug Design and Discovery Course: Drug Design Course code: 0510412 Dr. Balakumar Chandrasekaran Dr. Bilal Al-Jaidi Assistant Professors, Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy,

More information

Dr. Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil. On behalf of the FANTOM II investigators

Dr. Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil. On behalf of the FANTOM II investigators FANTOM II: Six-Month Clinical and Angiographic Results With a Radiopaque Desaminotyrosine Polycarbonate-Based Sirolimus-Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease

More information

Additive manufacturing for long term implants. Presentation Content

Additive manufacturing for long term implants. Presentation Content Additive manufacturing for long term implants Jac Koenen DSM Amsterdam February 4, 2015 Presentation Content DSM and DSM 3D printing of medical devices/implants Advantages Unique DSM materials Some Relevant

More information

Artificial blood vessels

Artificial blood vessels Artificial blood vessels S. Swaminathan Director Centre for Nanotechnology & Advanced Biomaterials School of Chemical & Biotechnology SASTRA University Thanjavur 613 401 Tamil Nadu Joint Initiative of

More information

PIB for Fun and Profit

PIB for Fun and Profit Polymers for Biology and Medicine Session: Biomaterials Entrepreneurship Santa Rosa CA, Oct. 9-12, 2013 PIB for Fun and Profit Entrepreneurship with Polyisobutylene Joseph P. Kennedy with many coworkers

More information

Coagulation Mechanisms Dr. Nervana Bayoumy

Coagulation Mechanisms Dr. Nervana Bayoumy Coagulation Mechanisms Dr. Nervana Bayoumy Associate Professor Department of Physiology Objectives At the end of this lecture you should be able to: 1. Recognize the different clotting factors 2. Understand

More information

LC/MS. Why is it the fastest growing analytical technique?

LC/MS. Why is it the fastest growing analytical technique? LC/MS Why is it the fastest growing analytical technique? Discussion topics Evolution of LC/MS Advantages of API Why should I use LC/MS? LC/MS markets Evolution of LC/MS interfaces 1970s to Present Moving

More information

Combinatorial Polymer Libraries to Elucidate Dendritic Cell Phenotype-Material Property Relationships

Combinatorial Polymer Libraries to Elucidate Dendritic Cell Phenotype-Material Property Relationships Combinatorial Polymer Libraries to Elucidate Dendritic Cell Phenotype-Material Property Relationships Kou, P.M. 1,Narayanan, P. 2, Joy, A. 2, Cunningham, B. 2, Kohn, J. 2, Babensee J.E. 1 1 Wallace H.

More information

For personal use only

For personal use only REVA Announces Positive 12-Month Clinical Results 4.2% rate of MACE equivalent to best-in-class drug-eluting stents San Diego, California and Sydney, Australia (Wednesday, 17 May 2017, AEST) At the Paris

More information

The Effects of Scaffold Rigidity on Retinal Pigment Epithelial Cells. Corina White Symposium on Biomaterials Science 24 October 2016

The Effects of Scaffold Rigidity on Retinal Pigment Epithelial Cells. Corina White Symposium on Biomaterials Science 24 October 2016 The Effects of Scaffold Rigidity on Retinal Pigment Epithelial Cells Corina White Symposium on Biomaterials Science 24 October 2016 Background Physiology The retina is the light-responsive tissue layer

More information

Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016

Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016 Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016 Bioabsorbable Stents (BAS) - Medical Devices Pipeline Assessment, 2016 BioPortfolio has been marketing business and market research

More information

DESIGN, FUNCTION AND USES. R. James Christie Oct. 4, 2008 Utsunomiya Girls High School

DESIGN, FUNCTION AND USES. R. James Christie Oct. 4, 2008 Utsunomiya Girls High School BIOCOMPATIBLE POLYMERS: DESIGN, FUNCTION AND USES R. James Christie Oct. 4, 2008 Utsunomiya Girls High School Biomaterials: Materials that Function with Living Organisms Materials that imitate natural

More information

Tissue Engineering: The art of growing body parts. Robby Bowles, Ph.D Cornell University

Tissue Engineering: The art of growing body parts. Robby Bowles, Ph.D Cornell University Tissue Engineering: The art of growing body parts Robby Bowles, Ph.D Cornell University What is Tissue Engineering? What is Tissue Engineering? TE is an interdisciplinary field that applies the principles

More information

Biomaterial Surfaces and Biointerfaces Surface Science II

Biomaterial Surfaces and Biointerfaces Surface Science II Biomaterial Surfaces and Biointerfaces Surface Science II April 29, 2013 Prof. Prabhas Moghe Biomedical Engineering; Chemical & Biochemical Engineering Rutgers University Moghe@rutgers.edu 1 Areas and

More information

colorimetric sandwich ELISA kit datasheet

colorimetric sandwich ELISA kit datasheet colorimetric sandwich ELISA kit datasheet For the quantitative detection of human IL1-beta in serum, plasma and cell culture supernatants. general information Catalogue Number Product Name Species cross-reactivity

More information

Drug Delivery from Cardiovascular Stents, In Pursuit of a Non-Polymeric Approach

Drug Delivery from Cardiovascular Stents, In Pursuit of a Non-Polymeric Approach Drug Delivery from Cardiovascular Stents, In Pursuit of a Non-Polymeric Approach B. Bell and D. Glocker, Isoflux Incorporated, Rochester, NY ABSTRACT Coronary heart disease (CHD) is the leading cause of

More information

Marcia L. Zucker, Ph.D. ZIVD LLC

Marcia L. Zucker, Ph.D. ZIVD LLC Marcia L. Zucker, Ph.D. ZIVD LLC 1 Monitoring hemostasis Bleeding Clotting 2 3 Extrinsic Pathway Monitor with ACT / aptt WARFARIN Monitor with PT Common Pathway X II Xa LMWH & DXaI IIa (thrombin) Hirudin

More information

Interventional Cardiology Advisory Group Meeting held 17 February (minutes for web publishing)

Interventional Cardiology Advisory Group Meeting held 17 February (minutes for web publishing) Interventional Cardiology Advisory Group Meeting held 17 February 2017 (minutes for web publishing) In consideration of the upcoming request for proposals for permanent coronary drug eluting stents (DES)

More information

Integration of Combinatorial Synthesis, Rapid Screening, and Computational Modeling in Biomaterials Development

Integration of Combinatorial Synthesis, Rapid Screening, and Computational Modeling in Biomaterials Development Feature Article 127 Summary: The advent of high-throughput combinatorial synthesis techniques in drug discovery has stimulated efforts to apply these techniques to the discovery of biomaterials. To be

More information

BEH.462/3.962J Molecular Principles of Biomaterials Spring 2003

BEH.462/3.962J Molecular Principles of Biomaterials Spring 2003 Lecture 17: Drug targeting Last time: Today: Intracellular drug delivery Drug targeting Reading: T.J. Wickham, Ligand-directed targeting of genes to the site of disease, Nat. Med. 9(1) 135-139 (2003) Drug

More information

Active biomaterials/scaffolds for stem cell-based soft tissue engineering (in a nutshell )

Active biomaterials/scaffolds for stem cell-based soft tissue engineering (in a nutshell ) Active biomaterials/scaffolds for stem cell-based soft tissue engineering (in a nutshell ) Emanuele Giordano Responsabile Lab ICM BioEngLab DEI CIRI SdV-TS Università di Bologna emanuele.giordano@unibo.it

More information

Drug /Device Combinations: The Convergence of Pharmaceutical and Biomaterial Science

Drug /Device Combinations: The Convergence of Pharmaceutical and Biomaterial Science Drug /Device Combinations: The Convergence of Pharmaceutical and Biomaterial Science Are We Just Raising the Stakes for Industry, Regulators, and Decision Makers? David Ames Director, Health Economics

More information

Introduction to Biomaterials

Introduction to Biomaterials Introduction to Biomaterials Objective To introduce the different biomaterials used in Biomedical Engineering To provide some fundamentals properties of these materials, And to indicate how they are used.

More information

Contrarian Play in Cardiology:

Contrarian Play in Cardiology: 6 UNDER THE LENS JUNE 30, 2015 Vol. 2, No. 12 Elixir Medical s Contrarian Play in Cardiology: by STEPHEN LEVIN Go Bioresorbable or Go Home Built on the efforts of innovative start-ups, interventional cardiology

More information

Cellular repair of damaged organs. Repopulating scaffoldings in kidney and liver

Cellular repair of damaged organs. Repopulating scaffoldings in kidney and liver Cellular repair of damaged organs Repopulating scaffoldings in kidney and liver Mireia Caralt, MD PhD Servei Cirurgia HBP i Trasplantaments March 29, 2017 Introduction Strategies to increase the number

More information

Cardiovascular stents: overview, evolution, and next generation

Cardiovascular stents: overview, evolution, and next generation https://doi.org/10.1007/s40204-018-0097-y REVIEW PAPER Cardiovascular stents: overview, evolution, and next generation Setareh Borhani 1 Shadi Hassanajili 2 Seyed Hossein Ahmadi Tafti 3 Shahram Rabbani

More information

ON THE DESIGN OF A BIODEGRADABLE POC-HA POLYMERIC CARDIOVASCULAR STENT JOONAS ILMARI PONKALA. Presented to the Faculty of the Graduate School of

ON THE DESIGN OF A BIODEGRADABLE POC-HA POLYMERIC CARDIOVASCULAR STENT JOONAS ILMARI PONKALA. Presented to the Faculty of the Graduate School of ON THE DESIGN OF A BIODEGRADABLE POC-HA POLYMERIC CARDIOVASCULAR STENT by JOONAS ILMARI PONKALA Presented to the Faculty of the Graduate School of The University of Texas at Arlington in Partial Fulfillment

More information

List of E-journals Subscribed for the year 2016 (January to December) Pharmacy Faculty Sl. No.

List of E-journals Subscribed for the year 2016 (January to December) Pharmacy Faculty Sl. No. Faculty 1 Adolescent Psychiatry Psychiatry 2 Anti Cancer Agents in Medicinal / Pharma & Quality 3 Anti-Infective Agents Pharmaceutical Microbiology 4 Anti-Inflammatory & Anti- Allergy Agents in Medicinal

More information

Raman Spectroscopy for Pharmaceutical Applications

Raman Spectroscopy for Pharmaceutical Applications Spectroscopy Solutions 2014 E conference Raman Spectroscopy for Pharmaceutical Applications Frederick H. Long, Ph.D. President, Spectroscopic Solutions, LLC History of Raman Spectroscopy Discovery of Raman

More information

Degradation rate. of bioresorbable materials. Prediction and evaluation. Edited by Fraser Buchanan. Woodhead publishing limited.

Degradation rate. of bioresorbable materials. Prediction and evaluation. Edited by Fraser Buchanan. Woodhead publishing limited. Degradation rate of bioresorbable materials Prediction and evaluation Edited by Fraser Buchanan Woodhead Publishing and Maney Publishing on behalf of The Institute of Materials, Minerals & Mining CRC Press

More information

The Balance of Safety, Efficacy, and Reasonable Assurance in DES An FDA View

The Balance of Safety, Efficacy, and Reasonable Assurance in DES An FDA View The Balance of Safety, Efficacy, and Reasonable Assurance in DES An FDA View Elizabeth Hillebrenner, MSE Interventional Cardiology Devices Branch Office of Device Evaluation Center for Devices and Radiological

More information

Tissue Engineered Medical Products

Tissue Engineered Medical Products WORKSHOP 8 Tissue Organizer: Jeremy J. Rawlinson PhD Speakers: Jack E. Lemons, PhD Lawrence J. Bonassar, PhD Mauro R. Alini, PhD Michael J. Yaszemski, MD, PhD Standards for Tissue J. Lemons, University

More information