COMET A truly innovative system to ease FFR

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

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

FFR : Growing clinical support

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National registry, Spain Use of FFR 90% 128, 000 coronary angiographies 68, 000 PCI 4. 3% 8%

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

FFR over diagnostic cath. FFR over PCI 11%

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 - Takes much time to set up and perform 47% 39% 25% Hannawi B, et al. Tex Heart Inst J 2014; 41: 579 -84

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

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

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

LAD PDA Dg LCx

Multiple FFR-target lesions in same patient

Courtesy of Dr. Javier Escaned

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

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

COMET Pressure Guidewire: design goals

COMET FFR guidewire Cutting edge technology DELIVERABLE � ACCURATE � DELIVERABLE – Synergy’s Laser-cut High Torque Sleeve ü Deliverability and performance ACCURATE – Optical Pressure Sensor ü Dependable data less drift SMART – Free Spin handle, Wireless connection ü Easy lab integration ü Unrestricted performance DELIVERABLE – Asahi Tip and Coatings ü 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. SMART

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.

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) ACTONE Key Tip Benefits Stainless Steel Core Precise Torque Response Optimal Tip Flexibility and Transition Durable Tip-shape Retention

Torqueability Performance Investigational Device. Under development. Not for sale in the United States. ® 2012 Boston Scientific Corporation or its affiliates. All rights reserved. IC-251003 -AA Jun 14

Simulated Lesion Model Evaluation Japan Comet Evaluation 9 8 7 6 5 4 3 2 1 0 Prowater Boston Scientific Torque Track Volcano Shape St. Jude 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.

COMET: Cath Lab Integration

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