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 CorporationLead the use of Mechanical Circulatory Support (MCS) to dramatically improve outcomes for patients with advanced stage heart failure and other cardiovascular diseasesMore than 18,000 patients implanted worldwide
3 Product Development Strategy Overview HeartMate II EvolutionNext-Generation PumpsCross-Platform Breakthrough TechnologiesMaintain HeartMate II as the best-in-class LVADGoGear PeripheralsDriveline durabilitySealed graftsG2 System ControllerLV attachment toolsMobile Power UnitIntroduce a range of pumps to significantly improve upon clinical capabilities of current commercial and clinical devices and expand the addressable patient populationsHeartMate IIIHeartMate XPHPIntroduce technologies which substantially enhance MCS therapy for both patients and clinicians, supporting both HeartMate II leadership and future pump platformsFILVASAutomated anastomosisInfection reductionWireless architectureRemote monitoringImproved Outcomes, Enhanced Quality of Life, Less Invasive Procedure, Real-Time Information, Reduced Cost of Care, Expanded Patient Populations
6 HeartMate GoGear System Components Battery ChargerHeartMate 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 manner14 volt Batteries and Clips (Li-Ion)Power ModuleKey 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.SmartController
7 Pump-end Bend Relief Enhancement Driveline DurabilityPump-end Bend Relief Enhancement(Launched 2010)Reduces the occurrence of Driveline pump-end bend relief fractures.Focus:Design:Note: Present at your own discretionKey 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 recoversallows range of angles between pump and inflow conduitarticulation allows adaptation and variety of VAD placement optionsSealed Outflow GraftFull commercial launch: Q1’2011Key messages:Eliminates pre-clotting and associated preparation time.Both inflow and outflow grafts have been FDA-approved and have received CE MarkHighly favorable reviews in broad-based evaluation in LME phase with over 300 implants in approximately 40 accounts worldwideSealed Inflow Conduit
9 HeartMate II G2 System Controller Advanced System Controller(Finalizing Design)Significant quality-of-life improvement for patientsSmaller and lighter than currently available controllersEasier cable managementCan be carried in patient’s pocketLCD and enhanced user interfaceEnhanced patient safetyBackup battery built into controllerFrontRegulatory 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 compromisedFlow, 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 ModuleAdditional: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 ControllerG2 ControllerWeight (g)~635~360Dimensions (cm)19.0 x 9.7 x 3.613.0 x 7.7 x 3.0Volume (cm3)~660~300Backup PowerNoYesLCD ScreenBack
10 Surgical Implant Tools – Left Ventricle Attachment Sewing Ring and Quick ClampLeft Ventricle Attachment(Finalizing Design)Coring tool designed to create and extract a clean, circular coreEase of cannula placementMaintains visibility into left ventricleReduced bypass timeSewing ring installed before coringReduced 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 consistencyCoring Tool
11 HeartMate Mobile Power Unit Indicators provide reassurance of device functionA/C PowerMPUMPU body incorporates cable management capability21’ power lead(fully extended)G2 System ControllerPowered Portability(Initiating Development)Highly portable tethered power solution with built-in cable managementSmall size, low weightIncreased ability to use tethered power with discretionKey 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 monitoringHighly 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 cordsSafe and durable: internal diagnostics (MPU Alarms), echoes System Controller alarms (even if power is lost), twist resistant cables, locked/retained cables
13 Next-Generation Pump – Projected Timelines 2011201220132014HeartMate IIIFirst-In-ManPHPHeartMate XAlso in Development
14 Ultra-Compact, Fully Mag-Lev VAD HeartMate IIIUltra-Compact, Fully Mag-Lev VAD(Finalizing Design)Full support (10L / min) in ultra-compact sizeIntrathoracic placement; centrifugal flowIncorporates critical HeartMate family design elements (e.g. large gaps, textured surfaces)Reduced adverse event profilePotential for reduced or no anticoagulationFull magnetic levitation optimized for efficiencyOperate at lower power consumption, allowing miniaturization of external componentsCapable of producing an artificial pulsePhysiologic blood flow with potential to help address late bleedingLeverage all product development initiatives from HeartMate IIProgram Status:Design freeze on pump, motor, controllerReliability testing: in process at component level, begin Q1’11 at system levelPreclinical meeting with FDA planned Q1’11Novel trial design strategyKey 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 gapsTogether these features provide the opportunity to have low or no dose anticoagulationHM 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 componentsAdditional:System will include GoGear, G2 driveline and G2 controllerThe 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 conditionsPercutaneous placement through 11F sheathCollapsible elastomeric impeller and nitinol cannula; expands to ~24FTargeted ApplicationsProgram Status:Development team hired through course of 2010Demonstrated ability to deploy, generate desired blood flow, and withdraw device in a bench modelKey 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 pressuresOver-the-wire placement across the aortic valveMaintain low hemolysis levels while allowing flow greater than 4.0 lpmEnable rapid set-up and ease of use comparable to IABPUnstable AMIHigh-risk PCIAcutely decompensated heart failurePotentially other patient populations
16 Dramatically Downsized Chronic Device HeartMate XDramatically Downsized Chronic Device(Technology Development)Versatile platform, capable of providing partial and full support (1-8 L/min)Leverages core HeartMate II technologyDramatic size reductionRapid, less invasive implantVersatile cannulation optionsMeets needs of expanded patient poolEarlier-stage patientsRVAD / BiVAD populationLow power consumptionPotential for smaller external batteries and componentsProgram Status:Two hydraulic configurations in developmentPreclinical studies underwayEvaluating multiple surgical access and cannulation optionsKey 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.
18 Cross-Platform Technologies 2011201220132014Fully Implantable SystemFirst-In-ManInfection ReductionAutomatedAnastomosisWirelessArchitectureRemoteMonitoringAlso in Development
19 Fully-Implantable LVAS (FILVAS) Fully Implantable System(Finalizing Design)No percutaneous lead – improved infection and system durability profileQuality of lifeNo daily dressingsAbility to swim and showerLess limitations on movementAdvanced battery technologyCustom cell technology tailored for implantable LVAD applicationTargeting “untethered” run times of ~3 hours initially and ~2 hours at 3-year markReduced size Implanted components with highly reliable electronicsEnergy Transfer CoilConfigured with choice of pumpKey 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 ControllerImplanted Battery
20 Infection Reduction Technology Project ObjectivesDevelop stabilization and exit site improvement technologies to significantly reduce percutaneous lead (driveline) infectionPursuing device-based internal mechanical stability anchoring technologiesFocus on trauma-induced late-onset infectionAdvanced exit site material morphology and chemistry for improved tissue / percutaneous lead interfaceKey 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 interfaceAdditional: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 cuffReproducibility - a mechanized tool/procedure eliminates variabilityShorten procedural time - reduce operative time by minutesKey Messages:Decrease required surgical complexity at LV Apex. Less cardiopulmonary bypass time, repeatability and consistency
22 HeartMate Wireless Architecture CurrentFuture****Both SM and PM are required for in-clinicprogramming and monitoringHeartTouchTablet ComputerWirelessSystem ControllerProject ObjectivesIn-clinic LVAS programming and monitoring platform aimed at reducing cost while improving practice efficiency and usability.Integrate wireless hardware into G2 System ControllerUtilize current System Monitor software & improveGraphic 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 PatientPatient Informationvia web pageWirelessSystem ControllerAlert NotificationsProject ObjectivesOffer a Remote Patient Monitoring solution for ongoing CCS devices that provides clinically relevant, accurate and trended parameter informationClinician 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 patientsAlert notification when an patient parameter exceeds a clinician set boundary conditionOffer a Remote Patient Monitoring solution for ongoing CCS devices that provides clinically relevant, accurate and trended parameter information to:Improve patient outcomesIdentify patient health problems earlier thereby mitigating a decompensation eventImprove practice efficiency and/or reduce practice costsHelp mitigate ER admits and clinic telephone callsProvide ability to trouble-shoot between office visitsReduce patient office visit frequency / durationProvide rural or long-distance patient coverageEstablish reimbursement and business model structures that allows for patient access
24 Realizing the New Era Thoratec® Product Development Initiatives 24
25 Appendix PVAD and IVAD Product Development Driveline Product DevelopmentHeartMate II Technology ReviewAppendix25
27 TLC-II Plus TLC-II Plus Driver (will launch in early 2011)Expanded RVAD capabilities allow for improved management of right-heart dysfunctionSupport for stable/unstableLVAD, RVAD, BiVADImproved reliability will allow 8,000 hours (~11 months) of maintenance-free operationCompact design allows home discharge: BiVAD patients the freedom to enjoy a more normal lifestyleThe 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 supportGreater 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 computerAllows wireless control, monitoring, and downloading of data from the TLC-IIEstablishes a new computer platform with the potential to support HeartMate devices in the futureThe 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.
31 Driveline Clinical Failure Modes Summary Through 12/31/2010: 6,594 implants4Points of wear and fatigue1325HM II Percutaneous Lead DamageRevision A-C(January 2004 ~1,010 impl.)Revision E+(June 2007 >5584 impl.)Bend Relief Separation / Controller-end Connector226 (22.4%)118 (2.1%)Jacket Cuts / Tears51 (5.0%)76 (1.4%)Tapered end of Controller Bend Relief45 (4.5%)8 (0.1%)Pump Housing29 (0.4%)General Trauma~4Wire Repair / replacements performed in the field24 (2.4%)11 (0.2%)12345
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 personnelKit includes:Perc Lead DiagnosticsOne replacement leadInstallation by two Thor Tech Services personnelPatient instructionsKey messages:An alternate solution to pump replacementAn externalized section of the driveline can be replaced by trained Thoratec Technical Services personnelAdditional: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 durabilityModular 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 anatomyKey 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 patientImproved driveline durability through enhanced bend relief and lead material technologyModular 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 locations3) 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 anatomyExternalized lead materials are tear and cut resistant while maintaining driveline flexibility and driveline diameterMultiple patient, clinician and cadaver studies have been conducted to assist in finalizing the design.
35 HeartMate II UpdateBest-in-Class LVAD: greater than 6,000 implants in real-world patient population at 254 centers as of year-end 2010Greater than 3,000 ongoing patients; durability profile extremely impressiveGreater than 700 patients supported 2 years or longerOver 60 patients for 4+ yearsLongest patient: 6+ years
36 HeartMate II – Design Features and Benefits Design BenefitsOptimized blood flowLow thrombosis riskLow anti-coagulation needsDurabilityDesign OverviewFlexible inflowLarge gaps–conduitoptimal flowdynamicsTexturedsurfacesHighly durableruby bearings–Rotor–singlenegligible wearmoving part
37 Optimized Flow Path and Impressive Durability Profile Bearing Technology4.4 year explantLarge GapsRotor spins on ruby bearingsBlood-immersedDesigned to prevent heat build-up that could damage blood and potentially cause thrombus formationNo reported failures in >6k implantsAnalysis of explanted pumps indicates an average expected bearing life of 60 years *Simplicity of design – single moving partInflow and outflow stators straighten the blood flow as it enters and exits the pumpLarge 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 SurfacesTextured SurfacesTechnology OverviewHallmark of HeartMate product family; technology refined over last two decadesTextured titanium surfaces on both the inflow and outflow cannulaEncourages the formation of a dense, adherent neointimal tissue layer *Tissue layer mimics that found in native arteriesReduces risk of thrombus formation generated by blood flow over foreign surfacesApplication in HeartMate IIPlatform technology applied across HeartMate family of products* Source: Zapanta et al, ASAIO, 2006, 52:17-23
39 Flexible Inflow Conduit Flexible Inflow Conduit – DesignTechnology OverviewFlex section consists of:Knitted polyester graft reinforced with a titanium ring and a silastic rubber sleeveFlexibility allows for relative movement between the native left ventricle and the LVADAccommodates reverse remodeling of heart over time while maintaining cannula position inside left ventriclePrevents misalignment against ventricular wallHelps avoid “suckdown” eventsSuction detection algorithmDetects suction events and automatically adjusts pump speedHelps prevent adverse events such as ventricular arrhythmias, flow interruption, or damage to the left ventricleInflow ConduitFlex Section
40 Hommage à celles qui ont travaillé au sein du Bureau au fil du temps 20ième congrès AFICCTHommage à celles qui ont travaillé au sein du Bureau au fil du temps