Post on 16-Dec-2015
transcript
27th January, 2010
Recent Product Launches
Recent Product Launches
S5/S5i
VH™ IVUSRevolution catheter
Latest AcquisitionsLatest AcquisitionsIP and Core TechnologiesIP and Core Technologies
Jomed
2003 Philips
(Rotational IVUS IP)
2004
Cleveland Clinic VH
2002
Initial venture funding in February
2001
Volcano Story
Current family of products all introduced in last 2 yearsCurrent family of products all introduced in last 2 years
FFRPrimeWire
NovelisForward Looking IVUS
2008
CardioSpectraOCT catheter
2007
AxsunLaser OCT
2008
Manufacturing HeadquartersRancho Cordova, CA
Corporate HeadquartersSan Diego, CA
Advanced Technology Lab
Cleveland, OH
Volcano Europe Brussels, Belgium
Volcano Japan Tokyo, Japan
Volcano China,Hong Kong,
ChinaVolcano Global Sales Atlanta, GA
Volcano OCT DivisionSan Antonio, TX
Volcano MAAndover, MA
Volcano Today
•Platform technologies for improving endovascular procedures
• 200+ global patents in IVUS, VH, FM, FL.IVUS and OCT
•Technology actor in interventional cardiology diagnostic • Recent clinical studies: FAME and PROSPECT reinforce the use of FFR
and IVUS (VH) to improve PCI’s outcome
•Numerous additional large market opportunities• Over 100 R&D engineers and scientists dedicated to new and existing
technology• Research Facilities in San Diego, Sacramento, Andover, San Antonio,
Cleveland
•Established global business with a track record of success
• Over 3,700 installed systems worldwide (>50% of hospitals with cath labs)
Volcano Platform
1. Volcano s5: 5 modalities on 1system
2. IVUS and FFR Integration with all X-ray Compagnies
Compatibility with GE, Philips, Siemens, Toshiba
3. Coronary and Peripheral Applications4. Vision for the future
– IVUS Guide Therapy, OCT, FL IVUS available soon on one multi-modality platform
IVUS and FFR PIM can hangfrom bed rail
s5i control devicescan be located atbedside and/orin control room
s5i image onmain bank
and in control room
Flexible, custom integration, through collaboration with cath
lab vendors (GE, Philips, Siemens)
Volcano s5i Integrated Cath Labs
GEPhilips
Siemens
Toshiba
IVUS/FFR integrated in every Cath lab type
Choice of 5 unique modalities
Revolution™ high frequency rotational IVUS for longer pullbacks and clinical study design
Choice of 5 unique modalities
Digital gray scale IVUS for fast, plug and play imaging
Choice of 5 unique modalities
ChromaFlo® stent apposition assessment to quickly confirm desired stent expansion and
placement
Choice of 5 unique modalities
Choice of 5 unique modalities
VH® IVUS tissue characterisation to identification of necrotic core
PrimeWire™ FFR functionality for reliable identification of ischemic lesions as seen in FAME
Choice of 5 unique modalities
Leadership through Vision
The development, release and timing of any features or functionality described for our products remains at the sole discretion of the company.
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SOLID STATE IVUS
ROTATIONAL IVUS
FFR
2010 Product Introductions
Pioneer/Medtronic
IGT
OCT2H 2010
IGT Balloon1H 2010
FL.IVUS 1H 2010
FL.IVUSTherapy 1H 2011
2011 Product Introductions
IVUS Guided Therapy - VIBE
Combined IVUS and Balloon •IVUS Platform : Eagle Eye Platinum•Balloon semi- and non-compliant
OCT provides a super high resolution tool to guide; – proper lumen sizing – full stent apposition– optimal stent expansion
Volcano OCTOptical Coherence Tomography
OCT can provide a super high resolution tool to identify; – Intraluminal thrombus– Thin cap fibroatheromas (10-15 micron resolution) – Other?
Stent with acute formation of white thrombus
Volcano OCTOptical Coherence Tomography
Proposed Volcano OCT Components
– Super-fast Spectral Domain
imaging catheter• Does not require balloon
occlusion for blood clearance• Similar to rotational IVUS design• 10-15 micron axial resolution
– Bedside user controls• The same user interface controls
IVUS and FFR
– Image on existing monitor bank
The development, release and timing of any features or functionality described for our products remains at the sole discretion of the company.
Volcano OCTOptical Coherence Tomography
Forward Looking IVUS
Forward Looking IVUS• PreView™
– Catheter-based– 1.5 mm imaging offset from tip– 45 degree off-set forward
looking cone– 5 mm forward– Imagine a funnel centred at your
eye and looking forward• Mackinaw™
– Same image– Pulsed RF energy delivered to
‘red’ target– Steering is enabled by rotating
the catheter and moving the target
5 mm
ahead o
f cath
eter t
ip
Ablation Region
Vessel Lumen
New Ultrasound
Lines
Intima
Media
Adventitia
2 mm ahead of catheter tip
• CTOs indication
• Successful product requires 3 attributes– Visualization, Steering, Dissection
• Design Considerations– Compatible with CTO guidewire of
choice– Ability to visualize at 45 degrees
when catheter approaches vessel wall
• Passive version for visualization only– Preview™
• Active version equipped with RF ablation– Mackinaw™
These Volcano Products are not currently available for sale. This document implies no guarantee as to future delivery or timing of these programs, and is meant only to highlight Volcano’s recent research & development efforts
Volcano FL.IVUSForward Looking IVUS to facilitate CTO crossing
FAME study: FFR vs. Angiography for Multivessel
EvaluationDemonstrated in 1,005 patients receiving DES for multi-vessel disease that FFR-guided PCIs resulted in lower MACE rates than angio-guided PCIs A gap in MACE rates was
evident within 30 days
FFR guidance used during the PCI procedure shifted the survival curve
upward resulted in superior
clinical outcomes Vs Angio
FFR guidance improves clinical outcomes in patients receiving DES for multi-vessel disease
FFR cost effective Vs Angio guided PCI
MACE @ 2 Years FU
The PROSPECT Trial: A Natural History Study of Atherosclerosis Using
Multimodality Intracoronary Imaging to Prospectively Identify Vulnerable Plaque
3-vessel imaging post PCICulprit artery, followed byCulprit artery, followed by
non-culprit arteriesnon-culprit arteries
Angiography (QCA of entire coronary tree)Angiography (QCA of entire coronary tree)
IVUSIVUS
Virtual histologyVirtual histology
Palpography (n=~350)Palpography (n=~350)
Repeat imagingRepeat imagingin pts with events in pts with events
Meds recMeds recAspirinAspirinPlavix 1yrPlavix 1yrStatinStatinRepeat biomarkersRepeat biomarkers@ 30 days, 6 months @ 30 days, 6 months
Proximal 6-8 cm Proximal 6-8 cm of each of each
coronary arterycoronary artery
Proximal 6-8 cm Proximal 6-8 cm of each of each
coronary arterycoronary artery
MSCTMSCTSubstudySubstudyN=50-100N=50-100 F/U: 1 mo, 6 mo,F/U: 1 mo, 6 mo,
1 yr, 2 yr,1 yr, 2 yr,±3-5 yrs±3-5 yrs
F/U: 1 mo, 6 mo,F/U: 1 mo, 6 mo,1 yr, 2 yr,1 yr, 2 yr,±3-5 yrs±3-5 yrs
The PROSPECT Trial: A Natural History Study of Atherosclerosis Using
Multimodality Intracoronary Imaging to Prospectively Identify Vulnerable Plaque
VH-TCFA (Thick Cap Fibrous Atheroma)VH-TCFA (Thick Cap Fibrous Atheroma)and and
Non Culprit Lesion Related EventsNon Culprit Lesion Related Events
Positive predictive value for future events
PIT (Pathological Intimal Thickening) PIT (Pathological Intimal Thickening) and and
Non Culprit Lesion Related EventsNon Culprit Lesion Related Events
Negative predictive value for future events
Summary
1. Volcano multimodalities in one platform– Five options in one system… available today!
2. DICOM / Worklist Compatible– Both DICOM store and Worklist
3. Endorsement by cath lab manufactures– Letters of compatibility with GE, Philips, Siemens
4. Coronary Applications– Full line of catheters for diagnosis and therapy guidance
5. Vision for the future– Track record of success, clear plan for the future
6. Make Volcano ‘essential’ to every cath lab– Our Vision is to make IVUS, FFR, VIBE, OCT, FL.IVUS, etc.
all available through the same user interface and workflow
Volcano provides the two pivotaltechnologies that clearly improve PCI:
IVUS/VH and FFR
Volcano provides diagnostic solutions to optimise the treatment of stable,
unstable and AMI patients
Volcano future OCT, FL IVUS, VIBE options will continue to improve PCI’s
outcome.
Angio alone is not enough
Angio alone is not enough
Right Patient, right lesion, right way!