1. New Pressure Wires and Catheters Systems for Measuring FFR:
Opsens FFR Technology and Clinical Data Update
Morton J. Kern , MD MSCAI, FACC, FAHA
Chief of Medicine
VALB Healthcare System
Long Beach, California
Professor of Medicine, UCI
Orange, California
28 Oct

2. Disclosure:
Morton J. Kern, MD
Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below.
Company Name Relationship
Abbott Medical Inc. Speakers’ Bureau
Philips Volcano Speakers’ Bureau
Merit Medical Inc. Consultant
Acist Medical Inc. Consultant
Opsens Consultant
Heartflow Consultant

3. Some Historical Challenges in FFR
Accuracy – Dealing with drift
Need for a workhorse wire – Dealing with pressure wire handling characteristics
Connections – Dealing with the procedural challenges of connecting and re-connecting during a case without impacting the pressure readings

4. Pressure Sensor wire and catheter Technologies
Piezo-Resistive Sensors
Micro-Catheter
Optical Fiber Technology
Specially constructed ” wires
Sensor at 3cm from tip
Piezo-electric sensor
Performance thought below dedicated coronary wires
St. Jude Medical
Volcano Therapeutics
Specially constructed ” nitinol wire
Sensor i3cm from tip
Fiber-optic sensor
Performance thought below dedicated coronary wire
Opsens
Boston Scientific
Rapid Exchange Micro catheter over wire with sensor incorporated into distal end
Fiber-optic sensor
Use over personal best wire
Acist Medical

5. Pressure Wire/Catheter Construction
Piezo-Resistive Sensors
Micro-Catheter
Optical Fiber Technology
Optical fiber

6. Available Sensor Construction
Piezo-Resistive Sensors
Micro-Catheter
Optical Fiber Technology
Piezo Resistive
Fiber Optic
Fiber Optic

7. Opsens OP2 Pressure Wire-Unique Characteristics
Deliverability: Improved wire handling with spiral nitinol construction
Reliability: Improved signal stability with optical sensors
Connectivity

8. Nitinol based construction enhances guide wire performance coupled with optical pressure sensor - Opsens Inc.
Optical fiber
Handle
FOIC optical connector to OptoMonitor
2 meter cable
Laser cut spiral stainless steel
Larger diameter Nitinol core – enhanced torque characteristic
Same form factor of market available guide wire. Respecting the FFR cut off value of landmark studies.

9. FFR Guidewire torque performance
OptoWire Torque transmission compared with two existing pressure guide wires and BMW.

10. What is the cause of signal drift?
AO/Procedure
Changing height of AO transducer
Capillary forces in catheter
Wedging guide in Ostium
Needle in Y-connector
Catheter with side-holes
Piezo-Resistive sensor
Temperature shift from room to patient
Calibration error
Blood, saline remnants on connector
Microscopic-air bubbles trapped inside sensor capsule
Optical sensor
Cavity width using a Fabry–Pérot white-light interferometer
Sensor not vulnerable to electrical interference.

11. Optical Pressure Sensors – Environment Effects
Conventional Optical: Temperature-induced pressure shift - - CTE silicon ≠ CTE Pyrex. Moisture-induced pr drift - Adhesive swelling induces mechanical stress
Opsens
Conventional Optical
Opsens: No temperature or moisture-induced shift - Corrugated diaphragm with central dot compensates moves diaphragm outward. Small amount of adhesive.

12. Zero drift test (mmHg / hr) <Not specified in IFU
FFR with Opsens - Zero drift1
Opsens - Accurate FFR measurement showing minimal drift1.
Published drift characteristics
OpSens
St. Jude2
Volcano
Boston Scientific3
Acist4
Zero drift test (mmHg / hr)
< 1
< 7
<Not specified in IFU
< 3
Per IEC ed3
St-Jude documentation #
BSCI Dr. Chambers presentation on TIP conference 2016
Acist 510K K filing.

13. Electrical pressure wire
144 lesions (11%) showed PD>3mmHg!
Assessed after 1 measurement
Courtesy of Hitoshi Matsuo M.D.,Gifu Heart Center

14. Optic fiber pressure wire Pressure drift>3.0mmHg (4/102=4%)
Pressure wire use as the workhorse wire
(2016/1/ /10/12)
102 lesions from 95 patients
Total procedure time (min)
98±29 min
Total contrast volume (ml)
110±43
Device exchange (times）
6±2
Max pressure (atm)
21±4
Rotablator/Jailed wire (case）
10/13
Drift in FFR value
0.013±0.013 [-0.07 – 0.02]
Drift in mmHg
1.2±1.1 [-5.0 – 2.0]
Optic fiber pressure wire
Pressure drift>3.0mmHg (4/102=4%)
FFR drift>0.03 (6/102=6%)
Assessed after whole procedure
ミリマーキュリー
Courtesy of Hitoshi Matsuo M.D.,Gifu Heart Center

15. Procedural FREEDOM and ease of use
Opsens - Optical
Pressure Guidewire
Optical contact, not electrical contact and not affected by saline and blood.
Reliable and simple disconnect and reconnect.
Piezo resistive
Piezo resistive pressure guidewire with electrical contact, more susceptible to moisture - saline and blood.
Electrical contacts alignment is critical in order to get accurate readings.
Physicians fear disconnecting current FFR wires due to constant loss of signal.
You can disconnect with faith OptoWire, perform PCI and reconnect once you need accurate measurement.
This is possible because of Opsens’ optical sensing technology with user-friendly connector.
You can also perform reconnection for multi vessels or to obtain post PCI FFR measurement.
Conclusion statement: FFR procedure is easier and simplify by Opsens’ connectivity to be almost a routine PCI procedure.
Electrical contacts

16. Optical Sensor connection not effected by blood – Courtesy of Dr
Optical Sensor connection not effected by blood – Courtesy of Dr. Nico Pijls

17. FFR with Opsens Optowire 2
Most Accurate FFR Device
Zero Drift* – Opsens’ latest generation fiber optic sensor
Fast, stable and accurate pressure signal
FFR Workhorse Wire
Excellent torquability, steerability, and deliverability
Using the FFR guidewire as standard PCI guidewire
Confidently disconnect for better vessel manipulation, over the wire procedures and post-stent FFR.
Continuous display of pressure throughout procedure