Robotic Catheter Intervention The Hansen Medical Sensei Robotic

Robotic Catheter Intervention: The Hansen Medical Sensei™ Robotic Catheter System Marvin J. Slepian, M. D. Professor of Medicine and Bio. Engineering Director, Interventional Cardiology Director, Tissue Engineering Lab Sarver Heart Center University of Arizona Tucson, Arizona 2011

Disclosures: Financial Relationship Company Grants Cardiogenesis, Hansen, Syn. Cardia Consulting/Honoraria Merck, Lilly, Pfizer, Sanofi. Aventis, Abbott Vascular, Hansen Syn. Cardia, Micro. Med, Arsenal, Leuko. Dx, MC 10 Major Stockholder/Equity Royalty Income Genzyme Ownership/Founder Syn. Cardia, Micro. Med, Hansen, Leuko. Dx, Arsenal, MC 10 Intellectual Property Rights Arsenal

Percutaneous endovascular intervention remains limited by issues related to catheter access, positioning and stabilization Future therapies in coronary and peripheral intervention, electrophysiology and structural heart disease require greater catheter finesse and control Robotic control of catheter manipulation affords the means for greater finesse greatly expanding therapeutic options in the cath and EP lab

Catheter-Based Therapeutics: Limitations Vascular access Vascular traverse Tortuosity, calcification, stenosis, aneurysmal dilatation Endoluminal entry Intracardiac traverse - transeptal Intracardiac stabilization Coronary angulation, tortuosity Micropositioning Microdelivery

Robotic Catheter-Based Intervention: Instinctive Motion Scaled Motion Vascular traverse (force-feedback) Variable Force sensing (Increased sensitivity, data) Precise navigation Difficult anatomy access Positional stability Microdelivery Reduction/Elimination radiation exposure Reduced operator fatigue Patient safety At-a-distance/telemetric operation

Sensei™ Robotic Catheter System Robotic Guide 1. Outter Work Station Remote Catheter Manipulator Console Displays Imaging modalities Hemodynamics 2. inner Patient Brand X “Trans-Txic Catheter Instinctive Motion Controller

Sensei™ Robotic Catheter System: Components Robotic Catheter Manipulator Physician Workstation Artisan™ Control Catheter

Instinctive Motion™ Controller (IMC) Operator natural “instinctive” motion Motion recorded, digitized Proprietary control logic Scaling of motion 5 cm 1 cm

Remote Catheter Manipulator Input from Instinctive Motion Controller Engages inner and outer catheter members Servo-motors continuously tensioning & re-tensioning pull wires Computer feedback loop (servo motors - position encoders)

Artisan Control Catheter Steerable inner guide – 11 Fr. OD, 8. 5 Fr. ID Off-the-shelf percutaneous catheter <8. 5 Fr. Steerable outer guide – 14 Fr. OD, 12 Fr. ID Telescoping Seven Degrees of Freedom Tight bend radius (270 o)

Intelli. Sense™ Fine Force Technology • Provides real-time measurement and display of the proximal force along the shaft of the percutaneous catheter • Detects small variations in force and displays them in a clear visual format • Early pre-clinical work suggests strong link between force and map quality 1 Road Feel! 1. Okumura Y, Johnson S, Packer D. An analysis of catheter tip/tissue contact force induced distortion of three-dimensional electroanatomical mapping created using the Sensei robotic catheter system. Heart Rhythm 2007; 4: S 318.

Co. Hesion™ 3 D Visualization Module = Ensite. TM + Sensei. TM • Importation of the St. Jude Medical En. Site® 3 D geometry, labels, and anatomical markers into the Sensei System’s main navigation window • Localization of the percutaneous catheter tip within the En. Site ® 3 D geometry • Artisan catheter navigating from within Ensite model Labels are imported from En. Site system Artisan catheter navigating from within En. Site model

Robotic Catheter: Precise Navigation, Mapping & RFAblation

REMOTE: Remote Manipulation Of Intra-Cardiac Catheter Study 63 pts, 5 centers - Outside the U. S. Atrial Arrhythmias Robotic catheter system + Mapping of RA/LA Robotic catheter-assisted RF ablation • End Points: 1. Navigation to Anatomical Targets 2. Targeting & delivery of RF Therapy 3. Safety

6 REMOTE: Results Intervention I. Navigation Intracardiac targets II. Ablation A flutter A fib Afib/flutter AVNRT Success 332/338 6/6 33/34 6/7 III. Safety 1 pt. pericardial effusion manual transseptal puncture

Approved Indication for Use US The Sensei Robotic Catheter System, and Artisan Control Catheter, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using pre-approved percutaneous mapping catheters. Europe Facilitate manipulation, precise positioning and control of percutaneous catheters within the atria of the heart. May 2, 2007

Clinical Cases by Arrhythmia Type Since Regulatory Clearance Installed sites (US +Europe) = 97 5000+ clinical cases AF Afl (13%) AVNRT WPW AF (75%) VT Other Data as of February 1, 2011 The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias, including atrial fibrillation, have not been established.

Hansen Medical Sensei. TM Stereotaxis Niobe. TM

Design Advantages Over Magnetic Technology Sensei Robotic Catheter System Magnetic Navigation Catheter tip motion Instinctive motion allows for precise placement of catheter tip Indirect vector driving leads to variable placement Variable Force Can vary force as required for optimal therapy Constant weak force only, inadequate tissue contact Measurement of contact pressure Quantification of contact between catheter tip and heart wall allows clinician to vary treatment Indirect indication of contact, no quantification of force Control multiple catheters Key to enablement of future procedures Magnetic field limited to steering of one catheter

Sensei™ Robotic Catheter System: Universal Endovascular Platform Structural Heart Disease Complex Vascular (Potential future application) Electrophysiology • Atrial flutter • Ventricular tachycardia • AVNRT, WPW • Atrial fibrillation • Aortic aneurysms • Carotid artery disease • CAD/PCI • Chronic total occlusions • Lower extremities • Venous applications (Potential future application) • Ventricular therapy • PFO closure • Mitral valve repair • Valve replacement Proprietary Tools 12 Fr. Artisan Catheter 22 7 Fr. Catheter (compared with current 12 Fr. Artisan)

Pre-clinical Renal Artery Cannulation: Tertiary Branch 7 Fr. OD Steerable Inner Guide 9 Fr. OD Steerable Outer Guide Investigational project, proof of principle, smaller Artisan catheter

In vitro cannulation of fenestrated aortic stent graft in aneurysmal model 1 Sensei™ Robotic Catheter System Conventional technique 1. The role of robotic endovascular catheters in target vessel cannulation. C. V. Riga, C. D. Bicknell, M. Hamady, N. J. W. Cheshire. The British Society of Endovascular Therapy (BSET), Birmingham June 2008

Robot-Assisted In-situ Stent Graft Fenestration Swine model, Right renal artery Stabilization, Localization Puncture Wire advance Cutting balloon Balloon dilatation Stenting Artisan inner Artisan outter 1. Robot-assisted in situ fenestration of aortic stent grafts. Riga CV, Bicknell CD, Hamady M, Cheshire NJW. Multidisciplinary European Endovascular Therapy (MEET) Congress, Cannes July 2008

Future Capability: Two Handed Procedures

Universal Angiographic Catheter

The Vascular Robotic Catheter System: Advancements in Flexible Robotics 6 French Sheath (OD comparable to 7 Fr Manual Sheath) 6 French Leader Sheath and Leader Compatible with 0. 018 to 0. 035 wires 4 way bending sections on Leader and Sheath For Research Purposes only. The Sensei® X Robotic Catheter System and Artisan™ Control Catheter are not approved for use In the described applications. The Vascular Robotic Catheter System is not approved or for sale. PP 0028 112310

Rapidity of Complex Access Robotic vs. Manual

Clinical Study First Human Use • 20 robotic endovascular interventions, including complex and diseased peripheral vascular anatomy • Study performed at the University Medical Centre in Ljubljana, Slovenia. – Borut Gersak, M. D. , Ph. D, and Milenko Stankovich, M. D. – University Medical Centre, Ljubljana – Alan Lumsden, M. D. , and Jean Bismuth, M. D. , – De. Bakey Heart & Vascular Center in Houston, Texas Hansen Medical Confidential and Proprietary. The Sensei® X Robotic Catheter System and Artisan™ Control Catheter are not approved for use in the described applications. The Vascular Robotic Catheter System is not approved or for sale.

Clinical Study First Human Use Conclusions: Patient Population: SFA Occlusions or Stenoses Tally: 20 Procedures, TASC A through D, including 6 CTOs • 15/20 procedures w/o using an introducer sheath • Hemostasis maintained in all patients • Successful robotic navigation, cannulation, and lesion crossing in all 20 procedures • Successful therapy delivery (angioplasty and stenting) through the robotic sheath in all 20 procedures Hansen Medical Confidential and Proprietary. The Sensei® X Robotic Catheter System and Artisan™ Control Catheter are not approved for use in the described applications. The Vascular Robotic Catheter System is not approved or for sale.

Summary: Hansen Sensei. TM system Integration of Robotic technology with Computational movement Integration of multiple imaging modalities to create a user friendly rotatable 3 D cardiac “work space” Precise, instinctive motion, positioning and stabilization of a variety of diagnostic and therapeutic catheter systems/devices Ex vivo, In vivo and Clinical studies: Safe and effective for diagnostic and therapeutic access and delivery to multiple intra-cardiac and vascular locations The System continues to evolve with enhanced potential