Agostoni - 2024 EuroCTO 2024 - Wolverine Cutting Balloon Rota combine.pdf

WORKSHOP by Boston Scientific
Calcium hands on: “Rotablation simulation set up and tips & tricks for complex cases.
Wolverine cracking model to demonstrate MOA”
Led by P. Agostoni, Belgium

1. In-Service Presentation
©2022 Boston Scientific Corporation or its affiliates. All rights reserved. IC-523701-AC

2. Product Design
2
The unique design of the WOLVERINE Cutting Balloon is designed with proprietary atherotomes
on a low pressure non-compliant balloon to directly address each of these complications
The WOLVERINE Advantage
Traditional balloon angioplasty can result in complications like:
VESSEL
DISSECTION
LESION
RECOIL
BALLOON
SLIPPAGE
POOR STENT
APPOSITION
POOR
LUMINAL GAIN
©2022 Boston Scientific Corporation or its affiliates. All rights reserved. IC-523701-AC

3. Balloon Matrix and Inflation Pressures
BALLOON BODY LENGTH
6 mm 10 mm 15 mm
BALLOON DIAMETER (mm)
2.00
3
Atherotomes
2.25
2.50
2.75
3.00
3.25
3.50
4
Atherotomes
3.75
4.00
5F Compatible
GUIDEZILLA II 6F
6F Compatible
GUIDEZILLA II 7F
INFLATION PRESSURE RATING
Nominal = 6 ATM
Rated Burst = 12 ATM
3
©2022 Boston Scientific Corporation or its affiliates. All rights reserved. IC-523701-AC

4. The WOLVERINE Edge is comprised of
the three unique mechanisms of action
4IC-1561711-AA Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display, or Distribute Externally.
Micro-incisions
regular, even expansion lines
Anchoring
No balloon/plaque shift
Force Amplification
Calcium fracturing
Ex. Fibrotic Lesions Ex. Eccentric Calcium
Ex. Calcium

5. Proven Mechanism of Action
5
Effective. Safe. Versatile.
1 Xiaodong Zhu et al.;Circ Rep 2021; 3: 1 – 8 doi: 10.1253/circrep.CR-20-0070. Results of computer models are not predictive of clinical performance. Clinical results may vary.
2 Bonan, J InvasivCardiol, 1999; 11: 230
3 Mangieri, A. Cutting Balloon to Optimize Predilatation for Stent Implantation: The COPS Randomized Trial, TCT 2022
4 Data on file. Photos taken by Boston Scientific. Results of internal bench studies are not representative of clinical performance. Clinical results may vary.
Atherotome
Cutting Height
127 μm
Human LAD
Media Thickness
2
320 μm
Human LAD
Wall Thickness
2
900 μm
Pre-clinical Swine Coronary artery post Cutting Balloon
1
Atherotome Atherotome Amplified Force.
1
The atherotomes anchor into the plaque and
amplify pressures generated by the balloon. This
creates controlled, longitudinal cracks in the
calcium.
1
1
Wolverine’s innovative design safely and
efficiently cracks calcium
3
Safely Cracks Calcium.
Due to its unique design, Wolverine can modify
calcium at lower pressures than POBA.
3
Atherotomes penetrate a small distance into the
vessel wall, even in healthy tissue.
4
2
©2022 Boston Scientific Corporation or its affiliates. All rights reserved. IC-523701-AC

6. •WOLVERINE atherotomes amplified balloon peak tensile strength
3X vs NC Balloon
•Force is focused at atherotomes for controlled even calcium
cracking
•Balloon dilation force is enhanced between the anchored
atherotomes
Xiaodong Zhu et al.;Circ Rep 2021; 3: 1 – 8 doi: 10.1253/circrep.CR-20-0070.
Results of computer models are not predictive of clinical performance. Clinical results may vary.
NC Balloon
3 mm
12 ATM
Cutting Balloon
3 mm
12 ATM
NC Balloon
3 mm
20 ATM
Treating Calcium with WOLVERINE
36
67
13
22
36
0
20
40
60
80
6 atm 12 atm 20 atm
Peak Tensile Stress (Mpa)
Inflation Pressure (ATM)
Peak Value of Maximum Principle Tensile Stress
(MPa)
Cutting Balloon NC Balloon
3X
Kiyotaka IWASAKI. Euro PCR 2019; Influences of thickness and circumferential angles of calcification on the capability of fracturing
calcification of the cutting balloon: an experimental investigation. Inflated up to 20 ATM until calcification model cracked in 37C water bath.
Results of bench models are not predictive of clinical performance. Clinical results may vary.
6
19
0
5
10
15
20
Wolverine 3x10mm NC Emerge 3x10mm
Average Fracture Pressure
(ATM)
Average Fracture Pressure (ATM)
400 μm 360⁰ Lesion
3X
360
o

Calcification
Model
Calcification Model Stress Distributions
©2022 Boston Scientific Corporation or its affiliates. All rights reserved.

7. The COPS Trial
Cutting balloon to Optimize Predilatation for Stenting
Randomization 1:1
High Pressure
Cutting Balloon
n=50
Non-Compliant
Balloon
n=50
Primary Endpoint
•Minimal Stent Area (MSA) at Calcium Site
Secondary Endpoint
•Eccentricity Index : (LD max – LD min) / LD max
Study Design
•Prospective, randomized, multicenter open-label trial
which enrolled 100 patients with significant calcified
lesions evaluated at IVUS
7
IC-523701-AC©2022 Boston Scientific Corporation or its affiliates. All rights reserved.
CB
(n=44)
NCB
(n=43)
Pvalue
Final MSA (mm
2
) 7.1±1.76.5±2.1 0.116
Minimal Stent Diameter 2.7±0.42.5±0.4 0.064
Maximal Stent Diameter 3.2±0.43.1±0.4 0.189
Final MSA at calcium site 8.1±2 7.3±2.1 0.035
Minimal stent diameter at calcium site2.9±0.72.7±0.4 0.016
Maximal stent diameter at calcium site 3.5±0.53.3±0.4 0.132
Eccentricity index at calcium site 0.84±0.70.8±0.8 0.013
WOLVERINE is clinically proven to provide superior
MSA at the calcium site compared to POBA
The benefit was
magnified in presence
of severe calcifications
7

8. The COPS Trial: Key Learnings
WOLVERINE is safe for calcium treatment,
even when inflated past rated burst pressure.
This difference was especially apparent
in cases with severe calcification.
WOLVERINE resulted in a significantly larger
minimal stent area at the calcified segment.
Stents had significantly more uniform expansion
after vessel preparation with WOLVERINE.
8
IC-523701-AC©2022 Boston Scientific Corporation or its affiliates. All rights reserved.

9. 9

10. 10

11. WOLVERINE Cracking Power in Action!
11
360˚ Calcium Simulated Lesion – Performed by Boston Scientific Research & Development IC-523701-AC©2022 Boston Scientific Corporation or its affiliates. All rights reserved.

12. In-service Presentation
for OS 2.0
IC-938001-AB

13. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
The Need to Treat Calcium is Growing
•Age
•Diabetes
•Renal failure
•Hypertension
•Smoking
Increasing
Risk Factors
•High-Risk PCI
•Pre-TAVR revascularization
New
Technologies
Calcium treatment needs
will continue to grow
over the next 10 years
IC-938001-AB

14. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Key Benefits
Minimize vessel trauma
1
Enable lesion access
2
Facilitate stent delivery
3
Optimize uniform stent apposition
4
Create larger MLD
5
Avoid Rota Regret
6
IC-938001-AB

15. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Key Benefits
•Differential Cutting
•The Rotablator
TM
Atherectomy
System is designed to ablate the
inelastic, calcified, atherosclerotic
tissue making up plaque in
coronary arteries
•All plaque is inelastic
•Helpful analogies:
•Shaving
•A nail file
Elastic tissue
Inelastic tissue

16. 16
No Change
Easier to use
Easier to set-up
Trusted Performance
•Same air drive
•Same drive shaft
•Same burr
ROTAPRO Design Goals
IC-938001-AB

17. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
ROTABLATOR System & Accessories
Console & Advancer Accessories
IC-938001-AB

18. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
ROTAPRO System & Accessories
ROTAGO Cart
Gold standard ROTABLATOR therapy on an enhanced, easy -to-use platform
Console & Advancer Optional Accessories
IC-938001-AB

19. 19
What is ROTAPRO with OS 2.0?
More Responsive
Adjusted advancer knob
deactivation settings; shortened
load time in normal and
dynaglide mode
Smoother Sound
Improved rotation stability;
smooth auditory feedback
Hands-Free Dynaglide
Additional functionality added to
control dynaglide via advancer
knob button for easier single-
operator technique
Update to console operating system which controls advancer functionality and performance
IC-938001-AB

20. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Disposable Components
ROTAPRO Pre-
Connected Advancer &
Burr
Burr Catheter
(Pre-attached)
Wireclip Torquer
& Rotawire
IC-938001-AB

21. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
ROTAPRO Pre-Connected
Advancer & Burr
Acts as a guide for the sliding elements which control burr extension
Controls on/off for either compressed air or nitrogen to the turbine to spin the
ROTABLATOR
TM
System turbine and burr
A brake within the advancer body is designed to hold the guide wire firmly
during burr rotation to prevent the wire from spinning or moving
Manipulation of the advancer knob allows independent
extension of the burr
Dynaglide (for system removal) is operated with easy to
use controls on the advancer
Advancer pre-connected with a burr
Burr sizes can be changed
IC-938001-AB

22. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
ROTAPRO Advancer Functionality
Advancer Knob On/Off
Button
(Press and release to
activate)
Dynaglide Momentary
On Button
(Press and hold to activate)
Brake Defeat Button
(Press and hold to
release brake while using
Dynaglide)
Dynaglide On/Off
Button
(Press and release to
activate)
Key Features
On/Off Located On Knob
•180
o
stop to lock in place
•“tap” proof to reduce accidental activation
•4s “oops” feature
Consolidated Connections
•Fiber optic, electrical, and air connections
combined into a single hub
Simple Activation
•Advancer knob buttons control activation
and deactivation of rotation
•Dynaglide On/Off allows for easy toggle
between normal and dynaglide modes
IC-938001-AB

23. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Dynaglide Mode
DYNA Mode Button
•Changes system between full speed and Dynaglide
•Confirmed by green advancer LED and console
indicator
Dynaglide Momentary button
•Press and hold
•Designed so brake release could easily be controlled at
the same time
Knob button
•Knob activates rotation for both
normal and Dynaglide modes
•Press and release (hands free)
IC-938001-AB

24. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Rotalink
®
Burr Catheter
Rotalink
TM
Burr Catheter:
•Sheath (4.3F) protects arterial
tissue from the spinning
driveshaft, and allows saline to
lubricate driveshaft.
•Elliptical shaped brass burr has
microscopic diamond crystals
embedded on the distal edge.
•Diamond crystals are 20
microns in size and extrude 5
microns from surface
•There are no diamond crystals
on the proximal side of the burr
Rotawire
Diamond Coated Burr
1.25 mm- 2.50 mm
Driveshaft
Sheath
4.3 F outer diameter
Reisman, M.D, Guide to Rotational Atherectomy Physicians Press, Birmingham, MI 1997
IC-938001-AB

25. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
RotaLink Catheter Connection
IC-938001-AB

26. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Rotawire Guide Wires
Both wires 330cm total length
Both wires 0.009” body with 0.014” Spring Tip Diameter
There are 2 wires available for use with the ROTA System
RotaWire Extra Support Guide Wire
•A stiffer frontline wire for:
•Distal lesions
•Heavily calcified proximal lesions
•Spring Tip (2.8cm)
RotaWire Floppy Guide Wire
•Used in 75% of cases
•First line wire due to:
•Significantly reduced guidewire
bias
•Spring Tip (2.2cm)
1
2
IC-938001-AB

27. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Highly Visible Safety Tip
014 platinum coil to provide visibility and
added safety during Rotational atherectomy
ASAHI Core Wire Technology
One-piece stainless steal core wire transmits
torque for predictable steering
Enhanced torque transmission for predictable and precise lesion access in calcified lesions
Unsurpassed Torque Transmission
Able to navigate calcified lesions with 1:1
torque through tortuous anatomy, providing
access for ROTAPRO
ROTAWIRE Drive Features
Reduce reliance on wire exchange devices, saving procedural time and lowering overall device spend
Improved Core Wire Durability
Improved kink resistance and wear
resistance compared to the legacy
Rotawire

28. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
ROTAWIRE Drive Features

29. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
ROTAWIRE Drive Features

30. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
ROTAPRO Console Air / Nitrogen
ROTAGO Cart
(Optional)
Hardware Components
IC-938001-AB

31. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Reset Button
RPM Adjustment
Knob
•Air Line
Connection
•Electrical
Connection
•Fiber Optic
Connection
ADVANCER
CONNECTIONS
Key Features
•Vibrant Digital Display – Enhanced
feedback and deceleration indicator
•IV Pole Clamp – Installation flexibility
•Intuitive Connections – Easy to identify
connections from advancer
•Default Startup Speed – Starts up at 160k
rpm (+/- 10k) when initially turned on
•Deceleration Alerts – Indicate 5k and 10k
drops
•Much better speed control since it is
now digital and not analog
(mechanical)
ROTAPRO Console Functionality
IC-938001-AB

32. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Console Indicators:
Check Pressure & Stall
Check Pressure Indicator
•Alerts you if the console is
receiving less than 30 PSI (206.8
kPa) of compressed gas
•Regulator still needed to ensure
you operate within pressure
requirements (90 – 110 PSI / 620.5 –
758.4 kPa)
Stall Indicator
•Stops burr when rotation drops below
15,000 RPM for ½ second or more
•Prevents burr from spinning if it
becomes stuck inside the lesion
IC-938001-AB

33. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Console Indicator: Deceleration
Provides additional procedural information to alert user to apply less pressure while burring
Alerts user of large speed drops which can create large particulate matter, generate excess heat and damage the vessel
Open Yellow Triangle
•Alerts you when burr rotation has
decreased 5,000 RPM from baseline
Closed Yellow Triangle
•Alerts you when burr rotation has
decreased 10,000 RPM from
baseline
IC-938001-AB

34. ©2020 Boston Scientific Corporation or its affiliates. All rights reserved. IC-938001-AA
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
* Never operate the ROTABLATOR Advancer without saline infusion.
Flowing saline is essential for cooling and lubricating the working parts of
the advancer. Operating the advancer without proper saline infusion
may result in permanent damage to the Rotablator advancer
**Do not allow the burr to remain in one location while rotating at high
speeds, as this may lead to wear of the guide wire (for instance: the burr
may cut the Rota wire when rotating in the same position on the wire for
extended periods of time). Gently advance or retract the burr while it is
in a high-speed rotary motion.
Drip
•Saline drip from bottom of
advancer and catheter*
Rotate
•Burr is rotating and RPMs are
stabile**
Advancer
•Free movement of advancer
knob
Wire
•Wire is visible and brake is
functioning
Pre Procedure Test – D.R.A.W.3
IC-938001-AB