UC201807293EE - Competitive Playbook - Abre - OUS

AbreTM
VENOUS SELF-EXPANDING STENT SYSTEM
COMPETITIVE
PLAYBOOK
Table of Contents
C.R. Bard Overview
➢ VenovoTM* Stent System
Veniti Overview
➢ ViciTM* Venous Stent System
Boston Scientific Overview

➢ WallstentTM* Endoprosthesis
Cook Medical Overview

➢ Zilver VenaTM *Venous Self-Expanding Stent
Optimed Overview
➢ sinus ObliquusTM* & sinus VenousTM* Self-Expanding Nitinol StentSystem
UC201807293 EE ©2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are
trademarks of Medtronic. TM* Third party brands are trademarks of their respective owners. All other brands are
trademarks of a Medtronic company. For Internal Use Only. Not for distribution. 02/18
Competitive Venous Stent Overview
Venovo ™* sinus-Obliquus ™* sinus-Venous ™* ZilverVena ™* VICI ™* WallStent ™*
•Dual Speed DS •Disease Specific •Venous •Stent Flexibility •Strong Radial •Strength and
•Flared Ends •Beveled End Conformity •Low-Profile 7fr Force Durability
•Comprehensive •Segmental •Unique Ring DS •Unique Hybrid •Prolific Data
Size Matrix Design Design Design •Repositionable
CE Mark 2016 IDETrial CE Mark 2015 CE Mark 2013 CE Mark 2010 IDETrial CE Mark 2013 IDETrial CE Mark 2015 Venous
indication not
approved in
US
Stent Material
Nitinol Elgiloy
Stent Design
OpenCell Closed Cell
VenovoTM* Stent System C.R. Bard
Company Overview – Bard | Peripheral Vascular

• Comprised of 4 divisions [Vascular, Urology, Oncology & Surgical
Specialty] and more than 15,000 products in 90 countries
• Markets products and services worldwide to hospitals, individual health
care professionals, extended care facilities, and alternate site facilities
• Net sales of $3.416B in FY ‘15 – a 3% increase over FY ’14 [$3.323B]
• Vascular - net sales of $970.3M in FY ‘15 – a 5% increase over FY ‘14
[$928.3M] representing 28% of total net sales in FY ‘15
• Vascular – CAGR of 5.1% [5-yearannual]
• Completed acquisition of Medicon Inc. in November, 2017 broadening
Bard’s breadth and depth in Japanese healthcare market [currently 3rd
largest]
• Website: http://www.bardpv.com/
Product Overview
The VenovoTM* Venous Stent System is the latest in the Bard stent portfolio that is designed to treat
stenosis and occlusions in the iliac and femoral veins.
Product Name/Model Venovo™* Venous StentSystem
Manufacturer Murray Hill, NJ [UnitedStates]
Indications For Use Treatment of stenosis and occlusions in the iliac and femoralveins
Delivery System Tri-axial OTW system with dual speed thumbwheel
Stent Material Nitinol [nickel-titanium] alloystent
Stent Design Open-celled
Introducer Sheath Compatibility (F) 8F [10mm & 12mm], 9F [14mm] , 10F[16mm, 18mm & 20mm]
GuidewireCompatibility 0.035 inches (0.89mm)
Catheter Working Length(s) (CM) 80 cm, 120cm
Product Images
VenovoTM* Stent VenovoTM *Stent
Delivery System
VenovoTM* Stent
Family
Competitor Strategies
Strategic Positioning
Available in the EU. As of Pricing (List)
Unique design elements [tri-
January, 2018not available axial delivery and flaredends] Distributor
in US make VenovoTM* stent • $2,805
system appealing to many
With a stent balloon and filter
physicians Direct
already in their deep venous
• $2,244
disease portfolio, it would not
be surprising if Bard pursues Designed specifically forthe
treatment of stenosis and ASP
clot removal device
occlusions in the iliac and • $1,300
[acquisition or organic] to
femoral veins
complete portfolio/broaden
deep venousstrategy
With a long history in Claims
Bundling of H.P. Balloon [Atlas] peripheral and deepvenous • No pertinent/current
and VenovoTM* stent system space, ‘foot-in-the-door’ claims/data at this time
positon Bard to have an opportunities mayexist.
advantage in pricing, as they
can offer a complete venous
portfolio
Advantages and Disadvantages
Advantages of Bard/VenovoTM* Stent System Disadvantages of Bard/VenovoTM* Stent System
▪ Bard is a formative competitor with a long ▪ STRENGTH: larger stent sizes have a lower
history/strong foothold in the deep venous compression resistance compared to smallersizes.
space; clot removal device would create a‘full ▪ EASE OF USE: First tri-axial delivery system
TM*
bag’ along with IVC Filter and Atlas high- with 2 dial-speed thumb wheels; may cause
pressure venousballoon confusionand affect placementaccuracy
TM*
▪ Venovo stent system received CE marking in ▪ SIZING: Offers robust size matrix, but catheterhas
2016 multiplediameters
▪ Strong strengthprofile ▪ DATA: VENACULAR US IDE Trial won’t be
▪ Sizing ranges from 10-20mm in diameter and a completed until September 2019; currenttrial
considerable array of lengths at 40mm – 160mm enrollment ended in February2017
▪ Compatible with 8, 9 and 10 (F)sheaths
All product performance claims are supported by internal bench testing data, and not indicative of clinical performance. Data on file.
Role Play - Physician Scenarios

Physician rationale for using VenovoTM* Stent Potential Response
System
STRENGTH • Strength is one of the key features for Bard
• Strength profile across all sizes is inconsistent. Strength decreases in larger sizes.
• The Abre™ stent has comparable strength and consistent strength across all diameters
• Key Abre™ stent design features are customized strut lengths and thicker diameter struts
to improvestrength over arterial stents
ENDURANCE • Bard showed some fractures in Medtronic's simulated durability test. The test
simulated extreme challenge bending during repetitive sitting and standing motions
• No in human test results available
EASE OFUSE • Bard’s thumb wheel delivery system is similar to the Abre ™ stent. However offers two speeds.
• This feature is intended to provide physicians more control.
• Two speeds may lead to confusion during the procedure and maydeliver less accurate
placement
FLEXIBILITY • Bard’s flexibility is limited due to its strength profile.

• The Abre ™ stent’s 3 connection points between cells enhance flexibility while
maintaining strength.
• The Abre ™ stent’s offset connection points also improves flexibility
SIZING • Sizing matrix is competitive however multiple sized delivery systems can make
inventory management difficult
Sizing Matrix
StentDiameter StentLength FrenchSize
10 40, 60, 80, 100, 120, 140,160 8(F)
12 40, 60, 80, 100, 120, 140,160 8(F)
14 40, 60, 80, 100, 120, 140,160 9(F)
16 40, 60, 80, 100, 120, 140,160 10(F)
18 40, 60, 80, 100, 120, 140,160 10(F)
20 40, 60, 80, 100, 120, 140,160 10(F)
ViciTM* Venous StentSystem Veniti
Company Overview – Veniti
• [Privately-held & Venture Capital-Backed] Develops, manufactures andmarkets stents

to treat patients with venous outflow obstruction in the lower extremities
• Secured $25 million from Boston Scientific [BSX] in 2016 to fund completion of its 200-
patient, 60-month VIRTUS clinical trial; final data collection completed in May 2017
• In 2017 signed agreement with Boston Scientific to distribute ViciTM* venous stent
system in EU.
• VIRTUS clinical trial is a 30-site [global], prospective, multicenter, single-arm,
non-randomized study; key endpoints are 12-month patency and safety
• ViciTM* venous stent system has been used on over 1,000 patients to date
• ViciTM* venous stent system currently not available for use in US market
• Website: http://www.veniti.com
Product Overview
The ViciTM* venous stent system was designed specifically for the treatment of venous disease and
is defined by crush resistance, uniform end-to-end strength and shape and controlled placement.
Product Name/Model Vici™* Venous StentSystem
Manufacturer St. Louis, MO & Fremont, CA [UnitedStates]
Indications For Use Veins of the lower extremities and pelvis, including the iliac and
common femoral veins, for the treatment of adult patients who
exhibit symptomatic venous outflow obstruction
Delivery System Coaxial OTW system with exterior shaft protection 9F
Stent Design Closed-celled [including proprietary bridges &braces]
Introducer Sheath Compatability (F) 9F [12mm, 14mm,16mm]
GuidewireCompatability 0.035 [0.89mm]
Catheter Working Length(s) (CM) 100cm
Product Images
ViciTM* Venous Stent ViciTM* Venous Stent
Deployment
Strategic Positioning
Distributed only in EU ViciTM* venous stents Pricing (List)
As of January, 2018not system is currently priced at Distributor
available in US. a premium in the EU market • $3,438
[steep pricing strategy may
discourage physicians from
Veniti is a small start-up Direct
buying-in, allowing
company and is a single- competitors to enter the • $2,750
product company with only market at a lower ASP]
the ViciTM* venous stent ASP
system. Veniti mayposition Uncertain how brand affinity • $1,900
itself to bepurchased/acquired resonates within current
physician base and if pricing
As a first-to-market venous structure can be maintained
stent, ViciTM* venous stent [avoiding significant erosion]
once MDT or larger [and more
system is positioned as ‘the’
strategic] medical device
first high-strength venous company enters the market
stent available in the deep
venous disease market
Advantages of ViciTM* Venous Stent System Disadvantages of ViciTM* Venous Stent System
▪ Superior radial force and crush resistanceare • ENDURANCE: Rigidity in stent design
key designfeatures createsa compromise in durability
▪ Differentiated by closed-cell designthat • EASE OF USE: Pin-pull delivery system
yields a high degree ofstrength may create a ‘jumping’ effect during
▪ Customer perspective signals intrigue due to deployment; may also require excessive
the benefits of its closed-cell/hybrid design pull-back force
due to its smooth surface and high strength • FLEXIBILITY: Extremely inflexible both
profile laterally longitudinally.
• SIZING: Provides inadequate or narrow size
matrix
• DATA: VIRTUS US IDE completed in
September 2017; minimaldata todate
Role Play – Physician Scenarios

Physician rationale for using ViciTM* Venous Potential Response
StentSystem
STRENGTH • Strength is one of the Vici™ stent’s key feature. Unique closed cell design improves its
strength profile
• The Abre™ stent’s design proves to be similar in compression resistance and stronger in
radial force on the bench.
• Key Abre™ stent design features are customized strut lengths and thicker diameter
struts.
ENDURANCE • Due to the Vici™ stent’s design it is significantly less durable than other venous stents
on the market today.
EASE OFUSE • Pin-pull system is less accurate than the Abre ™ stent’s tri-axial catheter delivery system.
• Some users may experience foreshortening of the stent after deployment
• The Abre™ stent system’s thumb wheel system provides more control over a pin-pull
system.
• The Abre™ stent’s tri-axial system eliminates friction between the introducer
sheath and the catheter enabling a more accurate stent placement
FLEXIBILITY • Vici™ stent unique closed celled design prevents the stents struts from bending and
flexing easily.
• The Abre ™ stent’s unique 3 connection points between cells enhance flexibility while
• Abre™ stent’s offset connection points also improves flexibility compared to in line
connection points on other stents
SIZING • Limited size profile. Only offer 12, 14, &16, and a max length of only 120mm
Sizing Matrix
12 60, 90,120 9(F)
14 60, 90,120 9(F)
16 60, 90, 120 9 (F)
Boston
WallstentTM* Venous Endoprosthesis Scientific
Company Overview – Boston Scientific

• [Public] Global medical device developer, manufacturer and marketer of a broad portfolio of
technologies within the cardiovascular space, including peripheral interventions among
others
• Deemed global market leader in peripheral interventions with robust solutions for the
treatment of deep vein thrombosis (DVT) anchored by recent launch of the AngioJetTM*
ZelanteDVTTM* Thrombectomy Catheter and the multi-purpose Wallstent™* venous stent
with multiple indication
• Reported FY ‘16 sales of $9,076B while achieving 12% growth,
• Raised $25 million for Veniti’s Vici in 2016 to fund completion of its 200-patient, 60-month
VIRTUS clinical trial; final data collection expected in May 2017
• Website: http://www.bostonscientific.com
Boston
Product Overview
The WallstentTM* venous endoprosthesis Stent aids in improving central venous luminal
diameter following unsuccessful angioplasty.
Product Name/Model WallstentTM* venous endoprosthesis
Manufacturer Marlborough, MA [UnitedStates]
Intended Use (venous) For patients with chronic hemodialysis with intraluminal stenosis of
the venous outflow tract
Delivery System Pull-pin [with UNISTEPTM Plus Delivery System]
Stent Material Elgiloy[Alloy]
Stent Design Closed-celled
Introducer Sheath Compatability (F) 6F, 7F, 9F, 10F
GuidewireCompatability 0.035 [0.89mm]
Catheter Working Length(s) (CM) 75 cm, 135cm
Boston
Product Images
WallstentTM* Venous WallstentTM* Venous
Endoprosthesis Endoprosthesis
Boston
Strategic Positioning Like Bard, BSX has a
foot-in-the-dooradvantage
over competitors dueto an Pricing (List)
Available in EU with venous already ‘full-bag’ in their deep Distributor
indication often used off-label in venous portfolio • $968
the US.
The Wallstent™* venous stent Direct
BSX has a complete/robust is adequately positioned in • $774
product portfolio in the deep countries with nominal or no
venous space with venous reimbursement in place for ASP
stent, clot removal, PTA venousstenting due to its low • $700
balloon and IVC Filter devices price compared to other
all available in at least 1 region venous stents
Claims Claims
• 6-month circuit secondary • ‘Reasonable’ safety and
To broaden overall venous
patency, stent primarypatency effectiveness for the treatment
product portfolio, BSX may of patients on chronic
and stent secondary patency
look to enter superficial hemodialysis following
rates at 68.6%, 33.8% and 75%
venous space through respectively for the patient unsuccessful angioplasty of the
acquisition or development cohort innominate and subclavianveins
Boston
Advantages of BSX/WallstentTM* Stent Disadvantages of BSX/WallstentTM* Stent
▪ Dominant ‘player’ in the deep venousspace • STRENGTH: Strength profile is lower at the
with a ‘full bag’ of products [Venous Stent,
Clot Removal, Venous PTA Balloon, IVC ends of stent
Filter] • EASE OF USE: Excessiveforeshortening and
▪ Portfolio breadth and depth havebetter
pin-pull delivery system
enabled ‘foot-in-the-door’opportunities
▪ Exhibits versatility in venous stenting due to • FLEXIBILITY: Closed cell designcreates less
its numerous indications, braided design and flexibility
wide-range of availablesizes
▪ OUS, the WallstentTM* stent is least costly, • SIZING: Large diameters (+20mm) available,
making it an attractive option where however lengths are limitedto 90mm
reimbursement is nominal/limited
▪ Much oftoday’s clinical data centers around
TM*
Wallstent stent
Boston

Physician rationale for using Potential Response
WallstentTM* Venous Endoprosthesis
STRENGTH • Strength is the key feature for the WallstentTM* stent.

• Strong compression resistance compared to other arterial stents
• Key Abre™ stent design features are customized strut lengths and thicker diameter struts to
improve strength compared to arterial stents
DURABILITY • WallstentTM* stent had zero breaks in Medtronic's simulated durability test. The test
simulated extreme challenge fractures during repetitive sitting and standing motions
• One of the few competitors with in human durability testing available
EASE OFUSE • Pin-pull system is less accurate then the Abre™ stent’s tri-axial catheter delivery system.
• The Abre ™ stent’s thumb wheel system provides more control over a pin-pull system.
• Abre™ stent’s tri-axial system eliminates friction between the introducer sheath and the
catheter enabling a more accurate stent placement
FLEXIBILITY • The WallstentTM* stent’s flexibility is limited due to its strength profile.
• Abre ™ stent’s unique 3 connection points between cells enhance flexibility while maintaining
strength.
• Abre™ stent’s offset connection points also improves flexibility
SIZING • Limited size profile, 10, 12, 14, 16 diameters
Boston
Wallstent™* Venous Endoprosthesis Scientific
Sizing Matrix (venous indication only)
10 20, 42, 68,94 6 (F) [for 20mm only] & 7(F)
12 20, 40, 60,90 9(F)
14 20, 40, 60,90 10(F)
16 20, 40, 60,90 10(F)
(venous indication only, other wallstent sizes avalaible)
Cook
Zilver VenaTM* Venous
Medical
Self-Expanding Stent
Company Overview – Cook Medical

• [Privately-held; Cook Group Affiliates {1 of 42 Cook companies}] World’s
largest privately-held medical device company; the Medical Manufacturing
‘arm’ of Cook specializes [Cook Incorporated - Diagnostic & Interventional
Products Division] in peripheral intervention technologies/devices
• Has over 16,000 products in over 135 countries worldwide
• VIVO Clinical Study is a prospective, non-randomized, multi-center study
intended to evaluate the safety and effectiveness of the Zilver VenaTM*
venous self-expanding stent in the treatment of symptomatic iliofemoral
outflow obstruction
• VIVO Clinical Study has 243 patients, a one-year primary endpoint and 29
active sites throughout the US, as well as one in Taiwan
• Website: http://www.cookmedical.com
Zilver VenaTM* Venous Cook
Self-Expanding Stent Medical
Product Overview
The Zilver VenaTM* venous self-expanding stent was developed to address maintaining blood flow in
obstructed iliofemoral veins. It provides flexibility, radial force and apposition from end-to-end.
Product Name/Model Zilver Vena™* Venous Self-ExpandingStent
Manufacturer Bloomington, IN [UnitedStates]
Indications For Use Intended for use in the iliofemoral veins for the treatment of
symptomatic venous outflow obstruction
Delivery System Pull-pin 7F
Stent Design Open-celled
Introducer Sheath Compatibility (F) 7F
Guide wireCompatibility 0.035 [0.89mm]
Catheter Working Length(s) (CM) 80,120
Product Images
Zilver VenaTM* Venous Self- Zilver VenaTM* Venous
Expanding Stent Self-Expanding StentPackaging
Strategic Positioning Portfolio strategy has
Available in EU, CE mark centered more on ancillary Pricing (List)
approved. As of January products based on existing Distributor
20178not available in the US platforms rather than novel • $2,629
innovations
Viewed as the first ‘dedicated’
venous stent to market. VIVO clinical research Direct
study designed to • $2,103
evaluate the safety and
Cook established relevance effectiveness of the ASP
with venous stent andIVC Zilver VenaTM* self- • $1,365
Filter, competitive deep expanding stent in the
venous space product treatment of
Claims – Preliminary European
symptomatic iliofemoral
presence • Stent placement resulted ina
venous outflow
obstruction more than two-fold
improvement in vessel
Encompasses
Premium priced, but lower list minimum lumen diameter
approximately 1/3 market
prices than current deep venous • Stent placementhas
competition share in IVC Filter market;
corresponded to improved
potentialcompetitive
account ‘foothold’ clinicaloutcomes
Zilver VenaTM* Venous Self- Cook
Expanding Stent Medical
Advantages of Cook/Zilver VenaTM* Stent Disadvantages of Cook/Zilver VenaTM* Stent
▪ Having received CE Mark in 2011, theZilver • STRENGTH: Difficult to differentiate

TM*
Vena Stent was the first venous stent on
the market froman arterial stent; obvious lack of
▪ As the first dedicated venous stent on the strength when squeezed/compressed
market, it has proven dedication to venous
• DURABILITY: Less compressive
disease and relevance in customers’minds
▪ Hallmark design elements center on its strength may cause the stent to be less
flexibility and ease ofuse durable
▪ Strong presence in procedural support
• EASE OF USE: Pin-pull delivery system
products and the IVC Filter (1/3 marketshare)
▪ European VIVO results have been metwith may cause a ‘jumping’ effect during
favorability around clinical and patient deployment
outcomedata
• SIZING: Narrow range of diameters that
severely limit treatmentoptions

Physician rationale for using Potential Response
Zilver VenaTM* Self-Expanding Stent
STRENGTH • Inadequate strength in both radial and compressive strength for the venous anatomy.
• Zilver Vena™* stent design platform resembles Cook’s arterial stent design .
• Key Abre™ stent design feature’s are customized strut lengths and thicker diameter struts
to improvestrength compared to arterial stents
DURABILITY • Zilver Vena™* showed 1fracture in Medtronic's simulated durability test.
• The test simulated extreme challenge bending during repetitive sitting and standing
motions
EASE OFUSE • Pin-pull system is less accurate then the Abre™ stent’s tri-axial catheter delivery system.
• The Abre™ stent’s thumb wheel system provides more control over a pin-pull system.
• The Abre™ stent’s tri-axial system eliminates friction between the introducer sheath and the
catheter enabling a more accurate stent placement
FLEXIBILITY • Key feature for Zilver Vena™* stent is it’s open cell design which enables the stent to bend
and flex with ease.
• The Abre™ stent’s unique 3 connection points between cells enhance flexibility while
• The Abre™ stent’s offset connection points also improves flexibility
SIZING • Limited size profile, 14, 16
Sizing Matrix
14 60, 100, 140 7 (F)
16 60, 100,140 7 (F)
sinus Obliquus™ *& sinus Venous ™ *
Optimed
Self-Expanding Nitinol Stent System
Company Overview – Optimed

• Engaged in research and development, production and global distribution of medical
products for minimally invasive therapies, including vascular interventions
• Markets a portfolio of over 2,400 products worldwide in 40+ countries and uses a
distributor sales model/network to position/sell it’s products globally [not
currently available within the United States forsale/distribution]
• Small sized company with approx. 100 employees at its corporate/manufacturing
headquarters
• Manufactures and sells 5 different venous stents (sinus-xl, sinus xl flex, sinus xl 6f)
• 2017 – Enrollment underway for TOPOS Trial
▪ 60 patient enrollment ≥18 years of age; completed by 2019; measuring primary
patency rate (3 months out to 2 years) using SO stent for the treatment of PTS inthe
iliofemoral veins
• Website: http://www.opti-med.de/en/home/
Optimed
Product Overview
The sinus Obliquus™* & sinus Venous™* stent are designed intentionally to address venous
obstruction .
Product Name/Model sinus Obliquus™* & sinus Venous™* Self-Expanding Nitinol Stent
System
Manufacturer Ettlingen, DE[Germany]
Indications For Use SO – Symptomatic obstructions of the femoral or iliac vein
SV – Symptomatic obstructions of the femoral or iliac vein
Delivery System Pull-pin, 10f [Obliquus & Venous]
Stent Material Nitinol [nickel-titanium] alloy stent [Obliquus &Venous]
Stent Design Open-celled body[Obliquus &Venous], Closed-Cell end (Obliquus)
Introducer Sheath Compatibility (F) 10F [Obliquus &Venous]
GuidewireCompatibility 0.035 [0.89mm] [Obliquus & Venous]
Catheter Working Length(s) (CM) 100 [Obliquus & Venous]
sinus Obliquus™* & sinus Venous™*
Stent System Optimed
Product Images
sinus ObliquusTM* & sinus
VenousTM* Stent System
sinus Obliquus™* & sinus
Venous™* Stent System Optimed
Strategic Positioning Utilizes distributionmodel: Pricing (List)

Products sold in Germanyvia Distributor
Available in EU. As of
product consultants and • SV: $2,960
January, 2018not
internationally via distributor
available in US • SO: $2,607
networks
Direct
Offers dedicated stents (5 in all):
Claims – sinus Venous™* stent • SV: $2,368
SV for power andflexibility
Proved safe and efficient to treat • SO: $2,086
SO for May-Thurner/NIVL
chronic venous obstructions, ASP
Currently offers venousstent May- Thurner lesions and residual • SV: $1,000
stenosis after thrombolysis, with • SO: $1,000
(SV & SO), high pressure
excellent patencyresults at one-
balloon and clot removal
year follow-up
devices in its deep venous Claims – sinus Venous ™* stent
product portfolio • Unique segmentaldesign • Cumulative primary patency
makes it the optimal was 97% at 3 months, 89% at6
Sales focused primarily in EU stent to treat venous months
market obstructivedisease
• Cumulative secondary patency
was 100% at 3 and 6 months
Claims are based off of single center, physician papers data and not a clinical study
Optimed

Advantages of Optimed/sinus Obliquus ™* Disadvantages of Optimed/sinus Obliquus™* &
&sinus Venous ™* Stent sinus Venous™* Stent
▪ Optimed offers specialized stents for both flexibility ▪ STRENGTH:
and MTS (May-ThurnerSyndrome) ▪ SV: open-celled, ring system lacks adequate strength
▪ SV forflexibility ▪ DURABILITY:
▪ SO forMTS ▪ SV: weak due to 2-strut flash links that connect rings
▪ The ideology of disease-specific stentsis well- ▪ SO: not necessarily designed to cross high-bend
received with physicians seeking a ‘defined’ anatomy
solution to treat venousdisease ▪ EASE OFUSE:
▪ Optimed offers a wide range of ▪ SV: moderate jumping duringdeployment
complimentary peripheralproducts, HP
▪ SO: high learning curve to orientate beveled end
balloons, and clot removal
▪ FLEXIBILITY:
Optimed has a strong foothold in the European
▪ SO: does not cross inguinal ligament
market and collaborates closely with KOL’s
▪ SIZING:
▪ sinus Venous™* stent has a high degree of
▪ SV: no large diameters (18mm or 20mm)
flexibility givesit an advantage over the Abre ™
stent in that category ▪ SO: 20mmdiameters

Physician rationale for using SO or SV Self- Potential Response
Expanding Stent System
STRENGTH • On the bench the Abre™ stent performs better then the SO in radial strength due to
its design (the measures of strength are an average of the beveled end , opposing end,
and middle section of the SO, and were not measure or compared separately)
• SV- Open celled structure enables it to be flexible but weakens its strength profile
DURABILITY • SV had zero fractures in Medtronic's simulated durability test.

• The test simulated extreme challenge bending during repetitive sitting and standing
motions
EASE OFUSE • Pin-pull system for both SO, and SV.
• Pin-pull systems can be less accurate then the Abre ™stent’s tri-axial catheter delivery
system.
• The thumb wheel system provide more control over a pin-pull system.
• The tri-axial system eliminates friction between the introducer sheath and the catheter
enabling a more accurate stent placement
• SO- Landing beveled edge at correct location can be challenging
FLEXIBILITY • SV key feature is flexibility.
• Open cell design enables stent to bend and flex with ease.
• The Abre™ stent system’s unique 3 connection points between cells enhance flexibility
while maintaining strength.
SIZING • Sizing matrix is competitive for SV,
• Sizing matrix is not competitive for SO, only offering 14, 16 diameters
Sizing Matrix
Stent Diameter (sinus Obliquus™* StentLength FrenchSize
Stent System)
14 80, 100,150 10(F)
16 80, 100,150 10(F)
Stent Diameter (sinus Venous™* Stent Length FrenchSize

Stent System)
10 60, 80, 100, 120,150 10(F)
12 60, 80, 100, 120,150 10(F)
14 60, 80, 100, 120,150 10(F)
16 60, 80, 100, 120,150 10(F)
18 60, 80, 100, 120,150 10(F)
Competitive Playbook Recap
Global
Strength Strength
Competitor Product Flexibility Ease ofUse Endurance Market
RF CR
Share*
Boston
Wall Stent™* 55%
Scientific
\
Optimed Obliquus™* 10%
Medtronic Abre™ 0%
Veniti VICI™* 15%
Bard Venovo™* 5%
sinus
Optimed 10%
Venous™*
Zilver
Cook Medical 5%
Vena™*
RF= Radial Force = Abre™ stent Baseline

CR =Compression Resistance = Better than Abre™ stent
*2017 Medtronic Strategic Plan = Worse than Abre™ stent
All data is based on internal bench top testing and may not represent in human use performance data
= Much Worse than Abre™ stent
DISCLAIMERS
All Abre™ stent product claims are based of internal bench testing. Data on file.
Bench testing data may not represent in human use performance data
Indications, contraindications, warnings, and instructions for use can be found in the product
labeling supplied with each device.

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AbreTM

VENOUS SELF-EXPANDING STENT SYSTEM

Boston Scientific Overview

Cook Medical Overview

OpenCell Closed Cell

Company Overview – Bard | Peripheral Vascular

Advantages and Disadvantages

Advantages of Bard/VenovoTM* Stent System Disadvantages of Bard/VenovoTM* Stent System

Role Play - Physician Scenarios

FLEXIBILITY • Bard’s flexibility is limited due to its strength profile.

StentDiameter StentLength FrenchSize

10 40, 60, 80, 100, 120, 140,160 8(F)

12 40, 60, 80, 100, 120, 140,160 8(F)

14 40, 60, 80, 100, 120, 140,160 9(F)

16 40, 60, 80, 100, 120, 140,160 10(F)

18 40, 60, 80, 100, 120, 140,160 10(F)

20 40, 60, 80, 100, 120, 140,160 10(F)

Company Overview – Veniti

• [Privately-held & Venture Capital-Backed] Develops, manufactures andmarkets stents

Advantages and Disadvantages

Role Play – Physician Scenarios

StentDiameter StentLength FrenchSize

12 60, 90,120 9(F)

14 60, 90,120 9(F)

16 60, 90, 120 9 (F)

Company Overview – Boston Scientific

Advantages and Disadvantages

Advantages of BSX/WallstentTM* Stent Disadvantages of BSX/WallstentTM* Stent

Role Play – Physician Scenarios

STRENGTH • Strength is the key feature for the WallstentTM* stent.

SIZING • Limited size profile, 10, 12, 14, 16 diameters

Sizing Matrix (venous indication only)

StentDiameter StentLength FrenchSize

10 20, 42, 68,94 6 (F) [for 20mm only] & 7(F)

12 20, 40, 60,90 9(F)

14 20, 40, 60,90 10(F)

16 20, 40, 60,90 10(F)

(venous indication only, other wallstent sizes avalaible)

Company Overview – Cook Medical

Advantages and Disadvantages

Advantages of Cook/Zilver VenaTM* Stent Disadvantages of Cook/Zilver VenaTM* Stent

▪ Having received CE Mark in 2011, theZilver • STRENGTH: Difficult to differentiate

Role Play – Physician Scenarios

SIZING • Limited size profile, 14, 16

StentDiameter StentLength FrenchSize

14 60, 100, 140 7 (F)

16 60, 100,140 7 (F)

Company Overview – Optimed

Strategic Positioning Utilizes distributionmodel: Pricing (List)

Advantages and Disadvantages

Role Play – Physician Scenarios

DURABILITY • SV had zero fractures in Medtronic's simulated durability test.

Stent Diameter (sinus Venous™* Stent Length FrenchSize

12 60, 80, 100, 120,150 10(F)

14 60, 80, 100, 120,150 10(F)

16 60, 80, 100, 120,150 10(F)

18 60, 80, 100, 120,150 10(F)

Veniti VICI™* 15%

RF= Radial Force = Abre™ stent Baseline