2 Introduction Drug-eluting stents have defined a new era in the successful treatment of coronary artery disease However, like any therapy, DES results.

Slides:



Advertisements
Similar presentations
Clinical Trial Results. org ABSORB Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Patrick W. Serruys.
Advertisements

Stenting: tips and tricks
“Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions Chronic Stable Angina, Silent Ischemia, Acute Coronary Syndromes Vessel Diameters:
PCI Unmet Clinical Needs
Subtitle Text Here Zylon Medical Devices Smaller Is Better Supported by NIH SBIR PHASE II Grant # 5 R44 H
Bifurcation coronary stenting: State 0f the Art Mazhar M Khan Consultant Cardiologist Royal Victoria Hospital Belfast, N.Ireland.
Calcified vessels – balloons that cut Azfar Zaman Freeman Hospital, Newcastle-upon-Tyne.
W e m a k e i d e a s c o m e a l i v e 001IHP For internal use only Not only a peripheral stent available in Renal sizes...
W e m a k e i d e a s c o m e a l i v e For internal use only Covering all your needs for Fem-Pop Interventions.
Optimal Stent Expansion and Optimization
Call for CASES Leszek D. Stachaczyk, MD Pawel Buszman, MD, FESC, FSCAI American Heart of Poland, Ustroñ, Poland & CCU, Upper-Silesian Center of Cardiology,
C. Graidis, D. Dimitriadis, A. Ntatsios, V. Karasavvides
Evaluation of ReeKross balloon catheter in treating iliofemoral artery chronic total occlusions Xinwu Lu Vascular Center of Shanghai Jiaotong University.
5F in 6F (7F) technique in DES era (Parent-child catheter technique)
1 *Report IIB(R) 27/ The CoStar Stent (Conor) was also tested but is not shown in this report as it only presents the commercially available stents.
Conventional Stenting Following Predilation and/or Debulking Is Better Than Direct Stenting Myeong-Ki Hong, MD, PhD Asan Medical Center, Seoul, Korea.
Tips and Pitfalls in Measurement of FFR during Bifurcation Stenting Nanjing first hospital Nanjing cardiovascular hospital Yefei Chenshaoliang Zhangjunjie.
BIOSENSORS-CLINICAL UPDATE “LEADERS AND BEYOND” John E Shulze, CTO BIOSENSORS INTERNATIONAL GROUP Jan 29, 2010.
Confidential: Internal Use only 1 Click to edit Master title style Click to edit Master text styles – Second level Third level – Fourth level » Fifth level.
Featuring CTO Complex-PCI by Trans-radial Approach CTO Case review 5 French TRI CTO of right coronary artery -5 F Launcher guiding Catheter (right Judkins.
TCT 2012 Revascularization Strategies for Complex Left Main Disease and Left Coronary Ostial Disease Alfredo E. Rodriguez, MD, PhD, FACC, FSCAI Centro.
左主干分叉病变治疗策略的选择 Left main bifurcation: what is the best choice? Lei Ge, MD Department of Cardiology, Zhongshan Hospital, Fudan University.
A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients TReated with Endothelial Progenitor Cell CapTuring Stents for De Novo.
Direct Stenting is Better (Debate Session) 동아의대 김 무 현.
New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager.
The First Affiliated Hospital of Harbin Medical University
Effect of Intravascular Ultrasound- Guided vs. Angiography-Guided Everolimus-Eluting Stent Implantation: the IVUS-XPL Randomized Clinical Trial Myeong-Ki.
Featuring Bifurcation Trans-Radial Approach Technical Issues Martial Hamon Caen, France Provisionnal T stenting With the Frontier stent Main Branch Balloon.
Saqib Chowdhary Wythenshawe Hospital STENT THROMBOSIS How Do IVUS & OCT Help.
Dedicated Bifurcation Stent Technology: Implications for Everyday Practice Jens Flensted Lassen MD, PH.D., FESC The Heart Centre, Rigshospitalet University.
Is there any role for intravascular ultrasound in bifurcation lesions? Giuseppe Biondi-Zoccai, MD University of Turin, Turin, Italy.
Date of download: 6/1/2016 Copyright © The American College of Cardiology. All rights reserved. From: 3D Reconstructions of Optical Frequency Domain Imaging.
Date of download: 6/2/2016 Copyright © The American College of Cardiology. All rights reserved. From: Retrograde Techniques and the Impact of Operator.
Double lumen remodeling balloon: New technique for treatment of MCA bifurcation aneurysm Kadziolka K, Leautaud A., Estrade L., W. Mustafa, Pierot L. CHU.
Date of download: 7/9/2016 Copyright © The American College of Cardiology. All rights reserved. From: Severe Neointimal Hyperplasia of Neoplastic Carina.
Date of download: 7/9/2016 Copyright © The American College of Cardiology. All rights reserved. From: Kissing Balloon or Sequential Dilation of the Side.
Date of download: 7/10/2016 Copyright © The American College of Cardiology. All rights reserved. From: Impact of Coronary Anatomy and Stenting Technique.
Intravascular ultrasound (IVUS) in the treatment of long and diffuse lesions– summary of key articles Prepared by Radcliffe Cardiology 21 November2016.
The Endocross Enabler-P: First in-Human Results
Takashi Ashikaga,MD,PhD
Bifurcation Balloon & Stent Delivery System
Invasive Assessment of Coronary Artery Disease
Abbott Vascular Bifurcation Program
Heavily calcified SFA lesions do not avoid the use of 4 F systems
Understanding Stent Deformation
Clinical Presentation
(DES)+BVS +DCB for long diffuse LAD disease
How to Handle a Complex Bifurcation Lesion
Paclitaxel Drug-Coated Balloons for De Novo Lesions
A Novel “Stent-On-A-Wire”Ultra Low Profile Stent Delivery System
Strategy planning in coronary bifurcation stenting
CRT Washington, D.C. February 23, 2010 Tim A. Fischell, M.D. FACC
Crossing SFA-Popliteal Artery CTO’s
A Fixed Guidewire Stent Delivery System
DES Bioabsorbable and DCB Technologies
The XIENCE V EXCEED Study
Subintimal Tracking and Reentry for CTO STAR Method
OCT-Guided PCI What needs to be done to establish criteria?
MACE Trial Rationale, Study Design, and Current Status
Regulatory Considerations for Coronary Drug Coated Balloons – FDA View
Circ Cardiovasc Interv
Circ Cardiovasc Interv
Advances in Interventional Cardiology
Successful retrieval of an entrapped coronary stent with its delivery system by small balloon dilatation at the entrapped site: A case report  Takashi.
Efficacy of a filter device in the prevention of embolic events during carotid angioplasty and stenting: An ex vivo analysis  Takao Ohki, MD, Gary S.
Successful retrieval of an entrapped coronary stent with its delivery system by small balloon dilatation at the entrapped site: A case report  Takashi.
NEW GENERATION STENT COBALT-CHROMIUM SIROLIMUS ELUTING STENT.
Impact of Diabetes Mellitus on Long-term Outcomes in the
APPROACH TO CORONARY BIFURCATION LESIONS
Presentation transcript:

2 Introduction Drug-eluting stents have defined a new era in the successful treatment of coronary artery disease However, like any therapy, DES results are not always what are predicted or expected, stent placement alone does not guarantee the best outcome Unless the stent is optimally deployed with full lesion coverage, full expansion and good apposition to the vessel wall, there remains a risk of complications such as late stent thrombosis

3 Introduction Such complications can compromise the benefits of the intervention and add to the cost of treatment Lesion preparation in general and pre-dilatation in particular can optimize stent deployment to better achieve the full benefits of DES therapy Optimal deployment assurance is vital to ensure good stent apposition and uniform absorption of the drug within the treated lesion Pre-dilatation may help reduce stent malapposition & late stent thrombosis

4 Powerline™ PTCA Dilatation catheter Messaging Messaging: The Powerline™ PTCA dilatation catheter is a high performance pre-dilatation workhorse balloon catheter designed to prepare the lesion for optimal DES placement, even in complex anatomy Powerline’s advanced catheter technology offers the right balance of PUSH, TRACK and CROSS to ensure optimal balloon placement and expansion Take the fast track to superior patient outcomes

5 Importance of pre-dilatation Pre-dilatation is not a matter of evidence based medicine What clinical data tells us: Previous studies reveal that direct stenting, as compared to pre- dilatation, has similar feasibility, efficacy and safety outcomes However, most of these studies have been performed only in the pre- DES era and in very selected patients with non-complex lesions Today >50% of case involve B2/C lesions On the other hand, pre-dilatation reduces costs, fluoroscopic exposure, procedural time and contrast use Not evidence based medicine, but experience and current practice have a real value Swibap study, H Le Breton et Al., Am J Cardiol 2001 Mehilli et al, Catheter Cardiovasc Interv Suselbeck et al, Int J Cardiol 2005 Trends study, KD Dawkins et Al., Am J Cardiol 2006

6 Importance of pre-dilatation Main risks of direct stenting: Inability to dilate the stent in heavily calcified or fibrotic lesions, which may lead to serious complications, i.e. surgery Incomplete stent deployment In-accurate stent placement Loss of guidewire and/or guiding catheter engagement due to insufficient support Stent shift due to watermelon seeding Stent dislodgement DES polymer damage (A)Coronary angiogram showing complete occlusion in the proximal left anterior descending artery segment, where a stent had been placed (C) Intravascular sonography shows the presence of gaps between stent struts (white arrowhead) and the vessel wall (black arrowhead). Heart May; 90(5): e26. doi: /hrt Stent malapposition is a main predictor of late stent thrombosis

7 Importance of pre-dilatation Pre-dilatation optimizes stent outcomes and may Assure optimal stent placement Identify un-dilatable lesions prior to stenting, hence avoiding serious complications Create a pathway for the stent Provide understanding of lesion length, diameter, and morphology Help to avoid complications with potential stent gaps or geographic misses Prevent damage to the drug coating during delivery Reduce plaque shift Reduce need for high pressure stent implantation Preserve sidebranches in bifurcations Reduce economic risk of improper DES selection Pre-dilatation may reduce stent malapposition & late stent thrombosis

8 Powerline™: Push - Track - Cross – achieving the right balance to meet the clinical need Powerline’s advanced catheter technology offers the right balance of PUSH, TRACK and CROSS, designed to ensure optimal balloon placement and expansion

9 Powerline™: Push - Track - Cross – achieving the right balance to meet the clinical need 1.9 F PTFe coated hypotube Power stylet Pushability Trackability Crossability Slip-X™ hydrophilic coating Flexible distal shaft Low profile tip with smooth diameter transition to balloon MultiPleat folding technology

10 The PTFE-coated hypotube in combination with the power stylet transition in the middle shaft provides the right balance between pushability and trackability offering a smoother force transmission from the proximal to distal portion of the catheter shaft. Excellent Pushability

11 The combination of the Slip-X™ hydrophilic coating and the flexible distal shaft ensure outstanding trackability and crossability for complex lesions or tortuous anatomy Excellent Trackability

12 The flexible low profile tip section with smooth transitions and short bonding offers a gradual increase towards the balloon to facilitate lesion entry. Powerline’s advanced MultiPleat folding technology is designed to offer exceptional lesion crossability and uniform balloon expansion as well as excellent balloon re-wrap and re- cross properties for treating challenging lesions. Excellent Crossability

13 Specifications

14 Powerline™ product schematic A.Flexible tip section with smooth transistions and short bonding to increase flexibility gradually B.Semi-compliant Pebax balloon material combined with Slip-X™ hydrophilic coating with for enhanced crossability C.Power stylet transition in the middle shaft provides a smoother force transmission from the proximal to distal shaft D.PTFE coated 1.9F hypotube for improved pushability A BC D

15 Powerline™ Balloon Markers Balloons Markers The distance between the markerbands (Outside to outside) will be equal to the advertised balloon working length The outside edges of the markerbands will match the edges of the balloon working length at nominal pressure

16 Powerline™ Guide Catheter Compatibility Powerline is compatible with 5F (min I.D ” / mm) 2 balloons for kissing balloon technique 3.0/20mm (or smaller ) can be used simultaneously within a guide catheter of 6F (I.D ” )

17 Balloon folds 4-fold 2-fold 3-fold All balloons are machine fold to ensure a consistent and re-producable primary profile as well as a low secondary profile for complex cases

18 Broad range of sizes

19 Compliance data * Nominal pressure ** Rated Burst Pressure

20 Powerline Excellent cross and re-cross properties The advanced MultiPleat folding technology provides a low crossing profile for excellent lesion crossability and uniform balloon expansion. It also provides an excellent balloon rewrap for low secondary profiles mm 4-fold mm 3-fold 1.5mm 2 folds

21 The combination of Powerline’s advanced catheter technology to pre-dilate the lesion and the BioMatrix drug-eluting coronary stent system, developed for improved healing and long-term safety, are designed to optimize your DES patient outcomes. BioMatrix offers the unique combination of a proprietary anti-restenotic drug, Biolimus A9™, a biodegradable poly-lactic acid polymer (PLA), and an advanced, highly flexible stent designed for enhanced deliverability. Powerline™ and BioMatrix™ – designed to optimize your DES outcomes