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Realizing the New Era Thoratec® Product Development Initiatives

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Presentation on theme: "Realizing the New Era Thoratec® Product Development Initiatives"— Presentation transcript:

1 Realizing the New Era Thoratec® Product Development Initiatives

2 More than 18,000 patients implanted worldwide
Thoratec Corporation Lead the use of Mechanical Circulatory Support (MCS) to dramatically improve outcomes for patients with advanced stage heart failure and other cardiovascular diseases More than 18,000 patients implanted worldwide

3 Product Development Strategy Overview
HeartMate II Evolution Next-Generation Pumps Cross-Platform Breakthrough Technologies Maintain HeartMate II as the best-in-class LVAD GoGear Peripherals Driveline durability Sealed grafts G2 System Controller LV attachment tools Mobile Power Unit Introduce a range of pumps to significantly improve upon clinical capabilities of current commercial and clinical devices and expand the addressable patient populations HeartMate III HeartMate X PHP Introduce technologies which substantially enhance MCS therapy for both patients and clinicians, supporting both HeartMate II leadership and future pump platforms FILVAS Automated anastomosis Infection reduction Wireless architecture Remote monitoring Improved Outcomes, Enhanced Quality of Life, Less Invasive Procedure, Real-Time Information, Reduced Cost of Care, Expanded Patient Populations

4 Agenda HeartMate II® Evolution Next-Generation Pumps Cross-Platform Breakthrough Technologies

5 HeartMate II® Product Evolution – Projected Timelines
2009 2010 2011 2012 GoGear Peripherals Worldwide Commercial Launch Driveline Durability Sealed Grafts G2 Controller Surgical Tools – LV Attachment Mobile Power Unit Initiating Development

6 HeartMate GoGear System Components
Battery Charger HeartMate GoGear System Components (Launched 2009) Redesigned system components support a patient’s recently restored active lifestyle, providing mobility and flexibility in a safe and secure manner 14 volt Batteries and Clips (Li-Ion) Power Module Key Messages: Smaller, lighter, more portable components. Up to 15 hour battery runtime has been a substantially positive impact on patient quality of life. Additional: The advancement in the battery technology has been substantial with many patients receiving up to 15 hours of run time per pair of batteries. This has been accomplished while reducing the weight of the batteries by 1/3. The 14 Li-Ion batteries only weigh 1 pound each. The new battery charger is compact and lightweight with rapid charging capability that nicely complements an on-the-go lifestyle. The power module is a highly portable and flexible power source. It is 1/3 the weight of the PBU, has an integrated back-up battery and offers the convenience of “plugging in” while in the car. Smart Controller

7 Pump-end Bend Relief Enhancement
Driveline Durability Pump-end Bend Relief Enhancement (Launched 2010) Reduces the occurrence of Driveline pump-end bend relief fractures. Focus: Design: Note: Present at your own discretion Key messages: Thoratec is constantly evaluating new ways to make its driveline technology more robust. With the enhancement in place, bench testing results show a 5-time improvement over the existing revision in terms of pump-end bend relief fatigue. Fatigue was found to be the root cause of the pump-end bend relief separation problem occurring in a small percentage of implanted HeartMate II patients (29 of over 6,594 implants or .4% as of 12/31/2010). Additional: Appendix slide is incorporated into this presentation to provide visibility into overall driveline failure modes.

8 Sealed Inflow Conduit and Outflow Graft
Sealed Inflow and Outflow (Outflow in limited evaluation) (Inflow in limited evaluation) Eliminates pre-clotting and associated preparation time. If needed, the Outflow Graft bend relief can be removed after initial attachment. Maintains flexible Inflow Conduit design: accommodates anatomic changes as patient recovers allows range of angles between pump and inflow conduit articulation allows adaptation and variety of VAD placement options Sealed Outflow Graft Full commercial launch: Q1’2011 Key messages: Eliminates pre-clotting and associated preparation time. Both inflow and outflow grafts have been FDA-approved and have received CE Mark Highly favorable reviews in broad-based evaluation in LME phase with over 300 implants in approximately 40 accounts worldwide Sealed Inflow Conduit

9 HeartMate II G2 System Controller
Advanced System Controller (Finalizing Design) Significant quality-of-life improvement for patients Smaller and lighter than currently available controllers Easier cable management Can be carried in patient’s pocket LCD and enhanced user interface Enhanced patient safety Backup battery built into controller Front Regulatory Submission: 3Q’11 (U.S. and EU) Key messages: Small size and low weight should reduce exit-site trauma if dropped and improve patient quality of life. Back-up battery is designed to maintain pump function for at least 15 minutes should accidental power disconnect occur. Built in driveline diagnostics provides capability to detecting whether driveline conductor integrity has been compromised Flow, PI, Power, Speed information are available through the controller’s on-board LCD display and can be accessed on-the-go without connection to a PM/PBU. On-board LCD screen eliminates Display Module Additional: Back-up battery usage is recorded, allowing for follow-up training with patient. All of the leads exit one side, enabling more wear options, including placement in a pocket. Enhanced two-stage driveline locking mechanism, designed to eliminate accidental disconnect. Controller stores last 6 events with timer, for ease of communication and interpretation. LCD messages translated into at least 28 languages. Multiple patient and clinician studies have been conducted to assist in finalizing the design. G1 Controller G2 Controller Weight (g) ~635 ~360 Dimensions (cm) 19.0 x 9.7 x 3.6 13.0 x 7.7 x 3.0 Volume (cm3) ~660 ~300 Backup Power No Yes LCD Screen Back

10 Surgical Implant Tools – Left Ventricle Attachment
Sewing Ring and Quick Clamp Left Ventricle Attachment (Finalizing Design) Coring tool designed to create and extract a clean, circular core Ease of cannula placement Maintains visibility into left ventricle Reduced bypass time Sewing ring installed before coring Reduced surgical time / enhanced ease of use (quick clamp) Regulatory Submission: End of 2011 (U.S. and EU) Key messages: Improves the standard procedure by minimizing bypass time (core after sewing ring is in place), introducing an advanced coring technique and facilitating an improved apical connection. Improves the HM II implant procedure to reduce surgical time, recovery time, and adverse events (e.g., bleeding) Decrease required surgical complexity at LV Apex. Less cardiopulmonary bypass time, repeatability and consistency Coring Tool

11 HeartMate Mobile Power Unit
Indicators provide reassurance of device function A/C Power MPU MPU body incorporates cable management capability 21’ power lead (fully extended) G2 System Controller Powered Portability (Initiating Development) Highly portable tethered power solution with built-in cable management Small size, low weight Increased ability to use tethered power with discretion Key messages: Will replace the Power Module for the discharged patient. The Power Module and System Monitor will continue to be maintained for in-clinic system programming and monitoring Highly portable and mobile: rubberized handle, cable management, small size, low weight (targeting ~2 pounds) Patients can make it from bed to bathroom in tethered mode without disconnecting: long cords Safe and durable: internal diagnostics (MPU Alarms), echoes System Controller alarms (even if power is lost), twist resistant cables, locked/retained cables

12 Agenda HeartMate II® Evolution Next-Generation Pumps Cross-Platform Breakthrough Technologies

13 Next-Generation Pump – Projected Timelines
2011 2012 2013 2014 HeartMate III First-In-Man PHP HeartMate X Also in Development

14 Ultra-Compact, Fully Mag-Lev VAD
HeartMate III Ultra-Compact, Fully Mag-Lev VAD (Finalizing Design) Full support (10L / min) in ultra-compact size Intrathoracic placement; centrifugal flow Incorporates critical HeartMate family design elements (e.g. large gaps, textured surfaces) Reduced adverse event profile Potential for reduced or no anticoagulation Full magnetic levitation optimized for efficiency Operate at lower power consumption, allowing miniaturization of external components Capable of producing an artificial pulse Physiologic blood flow with potential to help address late bleeding Leverage all product development initiatives from HeartMate II Program Status: Design freeze on pump, motor, controller Reliability testing: in process at component level, begin Q1’11 at system level Preclinical meeting with FDA planned Q1’11 Novel trial design strategy Key messages: This would be the smallest full-magnetically levitated (FML) device ever developed and first FML device designed to fit in the pericardial space. Designed to have low rates of pump thrombosis through: --Textured surfaces --Optimized blood flow --Wide blood gaps Together these features provide the opportunity to have low or no dose anticoagulation HM III has shown during bench testing that it is capable of producing a near-physiologic pulse by modulating the rate of RPMs. The FML design in HM II allows it to have full control over rotor ramp speed. Designed to operate at lower power consumption, allowing miniaturization of external components Additional: System will include GoGear, G2 driveline and G2 controller The FML design allows for optimized blood flow and wide gaps for blood passage versus hyrdodynamic designs (e.g., Coreaide, VentrAssist, HVAD) which rely on using the patient’s blood as a film to support the rotor. These hydrodnamically designed devices have narrower gaps for blood flow. FML design and wide gaps is thought to result in low rates of pump thrombosis, similar to how the wide gaps in HM II have resulted in low rates of pump thrombosis. Textured surfaces have been shown in the HeartMate I (XVE) and HeartMate II to lead to low rates of thromboembolism and allow for use of low-dose or no warfarin. Textured surfaces allow for the development of an intima layer similar to the innermost layer of an artery or vein. With textured surfaces, HM III is being designed for low-dose or no warfarin, similar to HM II and HM I. HM III will also benefit from the product development initiatives that are currently underway for HM II.

15 Percutaneous Heart Pump (PHP)
Catheter-based axial flow pump (Finalizing Design) Designed to deliver over 4L of flow under normal physiologic conditions Percutaneous placement through 11F sheath Collapsible elastomeric impeller and nitinol cannula; expands to ~24F Targeted Applications Program Status: Development team hired through course of 2010 Demonstrated ability to deploy, generate desired blood flow, and withdraw device in a bench model Key messages: This promising technology has the potential to address underserved patient populations including those with unstable acute myocardial infarction and acutely decompensated heart failure. Program Objectives: Develop a low-profile percutaneous LVAD that delivers full flow at normal physiologic pressures Over-the-wire placement across the aortic valve Maintain low hemolysis levels while allowing flow greater than 4.0 lpm Enable rapid set-up and ease of use comparable to IABP Unstable AMI High-risk PCI Acutely decompensated heart failure Potentially other patient populations

16 Dramatically Downsized Chronic Device
HeartMate X Dramatically Downsized Chronic Device (Technology Development) Versatile platform, capable of providing partial and full support (1-8 L/min) Leverages core HeartMate II technology Dramatic size reduction Rapid, less invasive implant Versatile cannulation options Meets needs of expanded patient pool Earlier-stage patients RVAD / BiVAD population Low power consumption Potential for smaller external batteries and components Program Status: Two hydraulic configurations in development Preclinical studies underway Evaluating multiple surgical access and cannulation options Key messages: Taking continuous flow to the next level. Leverages the HeartMate II technology in delivering a dramatically smaller chronic device. HeartMate X is an exciting pump platform that is dramatically smaller than currently available continuous flow devices and is being designed to be deployed via an innovative surgical procedure. Additional: The blood immersed bearings that are used in HeartMate II have proven to be extremely durable – pump explants show that there is virtually no discernable bearing wear in devices that have been in use for multiple years. Thoratec is exploring leveraging that blood-immersed bearing technology in a radically smaller pump design, currently referred to by a project the name : HeartMate X. On the bench, HeartMate X is demonstrating an improved power-consumption profile over HeartMate II and similar results in terms of hemolysis.

17 Agenda HeartMate II® Evolution Next-Generation Pumps Cross-Platform Breakthrough Technologies

18 Cross-Platform Technologies
2011 2012 2013 2014 Fully Implantable System First-In-Man Infection Reduction Automated Anastomosis Wireless Architecture Remote Monitoring Also in Development

19 Fully-Implantable LVAS (FILVAS)
Fully Implantable System (Finalizing Design) No percutaneous lead – improved infection and system durability profile Quality of life No daily dressings Ability to swim and shower Less limitations on movement Advanced battery technology Custom cell technology tailored for implantable LVAD application Targeting “untethered” run times of ~3 hours initially and ~2 hours at 3-year mark Reduced size Implanted components with highly reliable electronics Energy Transfer Coil Configured with choice of pump Key messages: Clinicians have consistently expressed an interest in a fully-implantable system (FILVAS) due to the potential of improved quality of life and reduced driveline infections. Fully implantable is not about the pump. FIVAS could use a HeartMate II or a future developed pump ( for example HM III or HM X). The focus of FILVAS is on the implantable battery and control system and the method to deliver power to that system. transcutaneous (across the skin) energy transfer (TET) Implanted Controller Implanted Battery

20 Infection Reduction Technology
Project Objectives Develop stabilization and exit site improvement technologies to significantly reduce percutaneous lead (driveline) infection Pursuing device-based internal mechanical stability anchoring technologies Focus on trauma-induced late-onset infection Advanced exit site material morphology and chemistry for improved tissue / percutaneous lead interface Key messages: Thoratec is pursuing technologically-enabled solutions to mitigate driveline infection. Studies have identified exit site trauma (e.g., system controller drops) as the primary cause of driveline infection. Early research is showing promising results in terms of internal anchoring methods and new driveline materials to mitigate trauma and improve driveline / tissue interface Additional: Internal anchoring has been a proven approach utilized with other medical applications. Thoratec is exploring materials and morphologies that might lead to advancements in terms of driveline / tissue interface.

21 Automated Anastomosis
Project Objectives “One shot" deployment tool that mechanically affixes an apical attachment device to the exterior of the heart’s left ventricle. Automate the procedure and eliminate routine sewing of today's cuff Reproducibility - a mechanized tool/procedure eliminates variability Shorten procedural time - reduce operative time by minutes Key Messages: Decrease required surgical complexity at LV Apex. Less cardiopulmonary bypass time, repeatability and consistency

22 HeartMate Wireless Architecture
Current Future ** **Both SM and PM are required for in-clinic programming and monitoring HeartTouch Tablet Computer Wireless System Controller Project Objectives In-clinic LVAS programming and monitoring platform aimed at reducing cost while improving practice efficiency and usability. Integrate wireless hardware into G2 System Controller Utilize current System Monitor software & improve Graphic interface (organization, layout) Incorporate Trending (PI, Flow, Speed, Power) Combines TLC II and HeartMate monitoring and programming platforms

23 Remote Monitoring Home or Office Home Internet Project Objectives Data
LVAD Patient Patient Information via web page Wireless System Controller Alert Notifications Project Objectives Offer a Remote Patient Monitoring solution for ongoing CCS devices that provides clinically relevant, accurate and trended parameter information Clinician is able to obtain LVAS data from a wireless G2 controller through a in-home router. Clinician can remotely observe and review data on all of their patients Alert notification when an patient parameter exceeds a clinician set boundary condition Offer a Remote Patient Monitoring solution for ongoing CCS devices that provides clinically relevant, accurate and trended parameter information to: Improve patient outcomes Identify patient health problems earlier thereby mitigating a decompensation event Improve practice efficiency and/or reduce practice costs Help mitigate ER admits and clinic telephone calls Provide ability to trouble-shoot between office visits Reduce patient office visit frequency / duration Provide rural or long-distance patient coverage Establish reimbursement and business model structures that allows for patient access

24 Realizing the New Era Thoratec® Product Development Initiatives

25 Appendix PVAD and IVAD Product Development
Driveline Product Development HeartMate II Technology Review Appendix 25

26 PVAD & IVAD Product Development

27 TLC-II Plus TLC-II Plus Driver
(will launch in early 2011) Expanded RVAD capabilities allow for improved management of right-heart dysfunction Support for stable/unstable LVAD, RVAD, BiVAD Improved reliability will allow 8,000 hours (~11 months) of maintenance-free operation Compact design allows home discharge: BiVAD patients the freedom to enjoy a more normal lifestyle The TLC-II Plus features a number of new enhancements that have been requested by customers: Expanded RVAD capabilities – a new compressor technology has been developed that generates higher RVAD ejection pressures to allow better management of patients with RV dysfunction, including those with elevated PVR or pulmonary hypertension. The TLC-II can now support both stable and unstable patients who may require LVAD, RVAD or BiVAD support Greater reliability – the new compressor also brings greater reliability, where routine service intervals increased in 2010 by 3X from 1,500 hours to 4,500 hours. This is equivalent to about 6 months of continuous device operation before routine servicing is required. In 2011, service intervals will further increase to 8,000 hours (11 months). Home discharge – the TLC-II Plus builds upon a proven platform and raises the bar in patient management for patients requiring biventricular support. These patients have the opportunity to enjoy a more normal lifestyle.

28 HeartTouch® Mobile HeartTouch Mobile
(will launch early 2011) Lightweight and portable touchscreen computer Allows wireless control, monitoring, and downloading of data from the TLC-II Establishes a new computer platform with the potential to support HeartMate devices in the future The HeartTouch Mobile is a new computer platform that is intended to replace the Docking Station for the TLC-II (and TLC-II Plus). The HeartTouch Mobile utilizes wireless technology to control and monitor the TLC-II as well as allow downloading of waveform or log file data for further analysis. The computer leverages Bluetooth wireless technology to communicate with the TLC-II wireless (Bluetooth) adapter. Bluetooth is recognized as a replacement for wired connections, including use in the clinical environment. Bluetooth does not interfere with other wireless technologies such as Wi-Fi and cellular technologies which are occasionally prohibited for use in the hospital due to interference concerns. The maximum wireless distance between the computer and TLC-II is about 30 feet with no obstacles in between. This new computer has the potential to allow cross-platform compatibility with the HeartMate devices in the future as we continue to integrate both wireless and monitoring capabilities into our products.


30 Driveline Product Development

31 Driveline Clinical Failure Modes Summary
Through 12/31/2010: 6,594 implants 4 Points of wear and fatigue 1 3 2 5 HM II Percutaneous Lead Damage Revision A-C (January 2004 ~1,010 impl.) Revision E+ (June 2007 >5584 impl.) Bend Relief Separation / Controller-end Connector 226 (22.4%) 118 (2.1%) Jacket Cuts / Tears 51 (5.0%) 76 (1.4%) Tapered end of Controller Bend Relief 45 (4.5%) 8 (0.1%) Pump Housing 29 (0.4%) General Trauma ~4 Wire Repair / replacements performed in the field 24 (2.4%) 11 (0.2%) 1 2 3 4 5

32 Perc Lead Wire Repair Kit
An alternate solution to pump replacement (Launched April, 2010) An externalized section of the driveline can be replaced by trained Thoratec Technical Services personnel Kit includes: Perc Lead Diagnostics One replacement lead Installation by two Thor Tech Services personnel Patient instructions Key messages: An alternate solution to pump replacement An externalized section of the driveline can be replaced by trained Thoratec Technical Services personnel Additional: Appendix slide is incorporated into this presentation to provide visibility into overall driveline failure modes. In all cases, critical diagnostics have to be completed before a repair can be conducted.

33 HeartMate III Driveline and Tunneling System
Capable of withstanding the rigors of daily life (Finalizing design) Enhanced driveline durability Modular lead section that can be replaced in case of damage or wear. Enhanced driveline tunneling system accommodates a wide range of patient sizes and variations in patient anatomy Key Messages: Capable of withstanding the rigors of daily life for a HeartMate III LVAS patient with an activity level expected of a NYHA Class I or II patient Improved driveline durability through enhanced bend relief and lead material technology Modular lead section that can be replaced in case of damage or wear. Enhanced tunneling system accommodates a wide range of patient sizes and variations in patient anatomy: 1) Longer implanted lead length (increased by 5 inches). 2) Two sizes of tunneling lances (16 and 24 inches) that allow for different techniques: tunneling outside in/inside out, alternative tunneling paths and exit site locations 3) The system controller connector is not tunneled anymore. 4) The small inline connector is now tunneled and allows the skin punch, used in exit site formation, to be reduced from 8MM to 6MM diameter (skin punch shown in pink). Additional: Appendix slide is incorporated into this presentation to provide visibility into overall driveline failure modes. Improved and intuitive visual indicators - Yellow line on system controller and inline connectors provide visual reassurance that the connection is fully made - White diamonds aid users in connection alignment. Bottom left picture shows tunneling lance, tunneling adaptor and lead prepped for tunneling. The tunneling adaptor is a single use product. Elegant design combines the benefits of extremely biocompatible silicone on the implanted portion with the benefits of cut and tear resistant polyurethane on modular lead. Incorporated armor layer with a kevlar-like material across the driveline length to further enhance durability. Tunneled connector diameter has been substantially reduced as compared to the current driveline “bullet”, which allows reduction for a tunneling path with a similarly reduced diameter. Accommodates a wide range of patient size (BSA range from 1.2 to 2.8 m2) and variations in patient anatomy Externalized lead materials are tear and cut resistant while maintaining driveline flexibility and driveline diameter Multiple patient, clinician and cadaver studies have been conducted to assist in finalizing the design.

34 HeartMate II Technology Review

35 HeartMate II Update Best-in-Class LVAD: greater than 6,000 implants in real-world patient population at 254 centers as of year-end 2010 Greater than 3,000 ongoing patients; durability profile extremely impressive Greater than 700 patients supported 2 years or longer Over 60 patients for 4+ years Longest patient: 6+ years

36 HeartMate II – Design Features and Benefits
Design Benefits Optimized blood flow Low thrombosis risk Low anti-coagulation needs Durability Design Overview Flexible inflow Large gaps conduit optimal flow dynamics Textured surfaces Highly durable ruby bearings Rotor single negligible wear moving part

37 Optimized Flow Path and Impressive Durability Profile
Bearing Technology 4.4 year explant Large Gaps Rotor spins on ruby bearings Blood-immersed Designed to prevent heat build-up that could damage blood and potentially cause thrombus formation No reported failures in >6k implants Analysis of explanted pumps indicates an average expected bearing life of 60 years * Simplicity of design – single moving part Inflow and outflow stators straighten the blood flow as it enters and exits the pump Large gaps minimize potential for stasis and thrombus formation * Source: Reichenbach et al, “Neglible Bearing Wear in Explanted HeartMate II LVADs Following Clinical Support for up to Four Years,” International Society for Rotary Blood Pumps (ISRBP), October 2010.

38 Platform technology applied across HeartMate family of products
Textured Surfaces Textured Surfaces Technology Overview Hallmark of HeartMate product family; technology refined over last two decades Textured titanium surfaces on both the inflow and outflow cannula Encourages the formation of a dense, adherent neointimal tissue layer * Tissue layer mimics that found in native arteries Reduces risk of thrombus formation generated by blood flow over foreign surfaces Application in HeartMate II Platform technology applied across HeartMate family of products * Source: Zapanta et al, ASAIO, 2006, 52:17-23

39 Flexible Inflow Conduit
Flexible Inflow Conduit – Design Technology Overview Flex section consists of: Knitted polyester graft reinforced with a titanium ring and a silastic rubber sleeve Flexibility allows for relative movement between the native left ventricle and the LVAD Accommodates reverse remodeling of heart over time while maintaining cannula position inside left ventricle Prevents misalignment against ventricular wall Helps avoid “suckdown” events Suction detection algorithm Detects suction events and automatically adjusts pump speed Helps prevent adverse events such as ventricular arrhythmias, flow interruption, or damage to the left ventricle Inflow Conduit Flex Section

40 Hommage à celles qui ont travaillé au sein du Bureau au fil du temps
20ième congrès AFICCT Hommage à celles qui ont travaillé au sein du Bureau au fil du temps

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