27th january, 2010. recent product launches s5/s5i vh™ ivus revolution catheter latest...

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27th January, 2010

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Page 1: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

27th January, 2010

Page 2: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 3: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 4: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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)

Page 5: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 6: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 7: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

GEPhilips

Siemens

Toshiba

IVUS/FFR integrated in every Cath lab type

Page 8: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

Choice of 5 unique modalities

Page 9: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

Revolution™ high frequency rotational IVUS for longer pullbacks and clinical study design

Choice of 5 unique modalities

Page 10: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

Digital gray scale IVUS for fast, plug and play imaging

Choice of 5 unique modalities

Page 11: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

ChromaFlo® stent apposition assessment to quickly confirm desired stent expansion and

placement

Choice of 5 unique modalities

Page 12: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

Choice of 5 unique modalities

VH® IVUS tissue characterisation to identification of necrotic core

Page 13: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

PrimeWire™ FFR functionality for reliable identification of ischemic lesions as seen in FAME

Choice of 5 unique modalities

Page 14: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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. 

14

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

Page 15: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

IVUS Guided Therapy - VIBE

Combined IVUS and Balloon •IVUS Platform : Eagle Eye Platinum•Balloon semi- and non-compliant

Page 16: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

OCT provides a super high resolution tool to guide; – proper lumen sizing – full stent apposition– optimal stent expansion

Volcano OCTOptical Coherence Tomography

Page 17: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 18: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 19: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

Forward Looking IVUS

Page 20: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 21: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

• 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

Page 22: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 23: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 24: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 25: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 26: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

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

Page 27: 27th January, 2010. Recent Product Launches S5/S5i VH™ IVUS Revolution catheter Latest Acquisitions IP and Core Technologies Jomed 2003 Philips (Rotational

Angio alone is not enough

Right Patient, right lesion, right way!