New Pressure Wires and Catheters Systems for Measuring

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 2016 @1415 -1430

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 Abbott Medical Inc. Philips Volcano Merit Medical Inc. Acist Medical Inc. Opsens Heartflow Relationship Speakers’ Bureau Consultant

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 3

Pressure Sensor wire and catheter Technologies Piezo-Resistive Sensors • Specially constructed 0. 014” wires • Sensor at 3 cm from tip • Piezo-electric sensor • Performance thought below dedicated coronary wires • St. Jude Medical • Volcano Therapeutics Micro-Catheter • Rapid Exchange Micro catheter over wire with sensor incorporated into distal end • Fiber-optic sensor • Use over personal best wire • Acist Medical Optical Fiber Technology • Specially constructed 0. 014” nitinol wire • Sensor i 3 cm from tip • Fiber-optic sensor • Performance thought below dedicated coronary wire • Opsens • Boston Scientific

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

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

Opsens OP 2 Pressure Wire-Unique Characteristics 1. Deliverability: Improved wire handling with spiral nitinol construction 2. Reliability: Improved signal stability with optical sensors 3. Connectivity

Nitinol based construction enhances guide wire performance coupled with optical pressure sensor - Opsens Inc. Optical fiber Laser cut spiral stainless steel Larger diameter Nitinol core – enhanced torque characteristic Handle 2 meter cable FOIC optical connector to Opto. Monitor 8

FFR Guidewire torque performance 1200 Opto. Wire Torque transmission compared with two existing pressure guide wires and BMW. Output rotation [ degrees ] 1000 800 600 Ideal 400 Opto. Wire BMW Volcano 200 St-Jude 0 0 200 400 600 Input rotation [ degrees ] 800 1000 1200 9

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.

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

FFR with Opsens - Zero drift 1 • Opsens - Accurate FFR measurement showing minimal drift 1. Published drift characteristics Zero drift test (mm. Hg / hr) 1. 2. 3. 4. Op. Sens St. Jude 2 Volcano Boston Scientific 3 Acist 4 <1 <7 <Not specified in IFU <3 <7 Per IEC 60601 -2 -34 ed 3 St-Jude documentation # 100018911. BSCI Dr. Chambers presentation on TIP conference 2016 Acist 510 K K 132474 filing.

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

Pressure wire use as the workhorse wire (2016/1/20 -2016/10/12) 102 lesions from 95 patients Optictime fiber wiremin Total procedure (min)pressure 98± 29 Pressure (4/102=4%) Total contrastdrift>3. 0 mm. Hg volume (ml) 110± 43 FFR drift>0. 03 Device exchange (times） (6/102=6%) 6± 2 Assessed after whole procedure 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 mm. Hg 1. 2± 1. 1 [-5. 0 – 2. 0] Courtesy of Hitoshi Matsuo M. D. , Gifu Heart Center

Procedural FREEDOM and ease of use Opsens - Optical Pressure Guidewire • • • Piezo resistive • Optical contact, not electrical contact and not affected by saline and blood. Reliable and simple disconnect and reconnect. 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. Electrical contacts

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

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