novel solutions for safe pericardial access and cardiac arrhythmia...
TRANSCRIPT
Novel Solutions for Safe Pericardial Access and Cardiac Arrhythmia Treatment
AFfix Medical Proprietary & Confidential
Founders and Management Team
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Founders Management Team
Rainbow Medical
Prof. Francesco Maisano University Hospital of Zurich
Prof K.H. Kuck Asklepios Klinik St. Georg, Hamburg, Germany
Michael Kardosh, Managing Director
Yossi Gross, Co-founder and CTO
AFfix Medical Proprietary & Confidential
The Need for Safe Pericardial Access
The Need for Effective and Safe Cardiac Arrhythmia Treatment
Currently Available Catheter Ablation: Multiple Drawbacks in the Gold Standard
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Precise contact force needed
Continuous line is a difficult to achieve
Transmural lesion is difficult to achieve
Time consuming: ~2 hours
Catheter Ablation Technologies
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LASER RF HIFU CRYO BIPOLAR HIFU
Hig
h E
ner
gy
Low
En
ergy
Too Little
No depth control
Too Little Too Little Too Much Safe
Transmural
Endocardium
Adjacent Organs
Epicardium
Pericardium
Blood
Hea
rt
mu
scle
CO2
The Newest Technology for Treating Cardiac Arrhythmia
Organs
Regular Ultrasound is Effective – But with Danger to Surrounding Tissue
AFfix Medical Proprietary & Confidential 8
Organs
Bipolar Ultrasound by AFfix Offers Mirror-Like Augmentation and Protection
AFfix Medical Proprietary & Confidential 9
“Mirror-like” augmentation and protection
Quick, effective and safe
Organs
CO2
AFfix Medical Proprietary & Confidential 10
Bipolar Ultrasound vs. Alternative Technologies
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Advantage of Bipolar HIFU Technology
LASER RF HIFU CRYO BIPOLAR HIFU
Hig
h E
ner
gy
Low
En
ergy
Too Little
No depth control
Too Little Too Little Too Much Safe
Transmural
Endocardium
Adjacent Organs
Epicardium
Pericardium
Blood
Hea
rt
mu
scle
CO2
AFfix Medical Proprietary & Confidential
Ventricular Tachycardia Treatment System
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1 2 3 4
Mapping Balloon
Ablation Catheter
Pericardium Access Device
Bi-Polar US Console
AFfix Medical Proprietary & Confidential
Bi-Polar Ultrasound Technology in Action
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AFfix Medical for AF AFfix Medical for VT
AFfix Medical Proprietary & Confidential
Bi-Polar Ultrasound Technology in Action
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AFfix Medical for VT AFfix Medical for AF
AFfix Medical Proprietary & Confidential
Unprecedented Performed on live beating heart
Effective Complete transmural penetration
Safe No Epi/Endocardiac damage
Preclinical Achievement: VT Complete Transmural Lesion
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Full 25mm Transmural Lesion
AFfix Medical Proprietary & Confidential
Ablation in Porcine Model
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AFfix Medical Proprietary & Confidential
Experience: Over 90 Porcine & Ovine Models
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HSR, Milan
Dr. Paolo Della Bella
Zurich University Hospital Prof. Francesco Maisano
Sheba Medical Center
Dr. Roy Beinart
Clinical and Regulatory Roadmap
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FIM Trial
CE Mark
Q3/16 Q2/17 Q4/15
AFfix Medical Proprietary & Confidential
Q1/16
Animal Safety Study
AFfix system for pericardial access and Bi-Polar Ultrasound:
A unique, safe and effective technology
Thank You
Michael Kardosh +972 54 5858764 [email protected]
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Septal Lesion – Initial Trial
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