1. COMET A truly innovative system to ease FFR
Jose M de la Torre Hernandez, MD, PhD, FESC
HUM de Valdecilla, Santander, Spain
MIT biomedical engineering center, Cambridge, MA

2. Disclosure for Conflicts of Interest
Jose M de la Torre Hernandez, MD, PhD, FESC
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Advisory/ Honoraria
Boston Sci, Abbott vascular, Biotronik, St Jude, Biosensors, Cardiva
Medtronic, Boston Sci., Volcano, AstraZeneca

3. FFR : Growing clinical support

4. Upgrade

6. National registry, Spain
Use of FFR
90%
128,000 coronary angiographies 4.3%
68,000 PCI 8%

7. U.S. trends in utilization of FFR, FFR-guided PCI and PCI
NIS data set from 2008 to 2012
4.4% over PCI
Pothineni NV, et al. JACC 2016;67:732-3

8. FFR over
diagnostic cath.
FFR over PCI
11%

9. Use of Fractional Flow Reserve:
A nationwide survey in U.S.
1,089 interventionalists
57% used FFR in less than 1/3 of cases
15% never used it
Primary reasons for not using FFR were:
- Lack of availability %
- Problems with reimbursement 39%
- Takes much time to set up and perform 25%
Hannawi B, et al. Tex Heart Inst J 2014;41:579-84

10. What would you like to see improved
in FFR systems ?
A survey among FFR users (PCR, 2016)
The integration in Cath Lab
The wire
The screen display - software
The cost

11. What would you like to see improved
in FFR systems ?
A survey among FFR users (PCR, 2016)
The integration in cath Lab
The wire
The display, software,….
The cost
Wire FFR = Wire PCI
SEC fellows course 2015

12. Navigation challenges for pressure wires
Lesions in distal segments (segments <2.5 mm)
Lesions located in very tortuous (+ diffusely calcified) or
markedly angulated vessels
Diseased bifurcations with ambiguous side branch involvement
“Jailed” side branches (metallic DES or BRS) with ambiguous
stenosis or restenosis
Lesions in diffusely diseased saphenous vein grafts

13. LAD
PDA Dg
LCx

14. Multiple FFR-target lesions
in same patient

15. Courtesy of Dr. Javier Escaned

16. Traditional Guidewires vs. FFR wires
Wire core
Stability
Integrity
Torque
Rail support
Tip
Shapeability
Steerability
Traditional FFR Wire
Hollow Wire
Hollow wire body for
sensor connection
Tip
Separated from wire body by the sensor
Sensor Housing
Piezoelectric sensor
Solid rigid housing
Abrupt transitions proximal and distal to the sensor
Key Guidewire Performance Features
Smooth transition from distal to proximal ends
Torque transmitted via wire core
Rail support via wire core
Traditional FFR Performance Drawbacks
Abrupt transitions around solid rigid housing
Poor torque due to hollow wire body
Drift sensitive piezoelectric sensor

17. The Future of all FFR Devices
Overcome Piezoelectric Connection Issues
Drift
Failed connections due to piezoelectric limitations
Improved Transitions Around Solid Rigid Housing
Not cause dissections
Not prolapse too easily
Maintains pusability
Without causing sensor error
Improved torqueability
Overcome hollow wire limitations
Overcome handle restriction limitations

18. COMET Pressure Guidewire: design goals

19. Cutting edge technology
COMET FFR guidewire
Cutting edge technology
DELIVERABLE
ACCURATE
SMART  
DELIVERABLE – Synergy’s Laser-cut High Torque Sleeve
Deliverability and performance
ACCURATE – Optical Pressure Sensor
Dependable data less drift
SMART – Free Spin handle, Wireless connection
Easy lab integration
Unrestricted performance
DELIVERABLE – Asahi Tip and Coatings
Better tip transition with performance coatings
Investigational Device. Under development. Not for sale in the United States.
® 2012 Boston Scientific Corporation or its affiliates. All rights reserved.

20. The Future of FFR is Optical
ACCURATE Data  Less Drift, Better Accuracy
SMART robust connection (less blood connection issues)
Pressure
Investigational Device. Under development. Not for sale in the United States.
® 2012 Boston Scientific Corporation or its affiliates. All rights reserved.

21. Asahi Tip with ACTONE and Dual-Coil Technology
Asahi Hydrophilic Coating
(Asahi Ultrathin film coating process)
Silicone Coating
(Asahi Ultrathin film coating process)
Spring Coil
Laser-cut Hypotube
(Leveraging Synergy’s technology)
Stainless Steel Core
ACTONE
Precise Torque Response
Optimal Tip Flexibility and Transition
Durable Tip-shape Retention
Key Tip Benefits

22. Torqueability Performance
IC AA Jun14
Torqueability Performance
Investigational Device. Under development. Not for sale in the United States.
® 2012 Boston Scientific Corporation or its affiliates. All rights reserved.

23. Simulated Lesion Model Evaluation
Testing performed in Miyazaki Japan Dec 2014 and Jan 2015 in both Boston Scientific and Asahi lesion models. N=7
® 2012 Boston Scientific Corporation or its affiliates. All rights reserved.
Investigational Device. Under development. Not for sale in the United States.

24. COMET: Cath Lab Integration

25. COMET: Designed to boost FFR Primary reasons for not using FFR were:
-Takes much time to set up and perform
-Lack of availability
- Problems with reimbursement