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Objectives • Preview of our newest pump platform • Overview of Performer ® CPB features • Clarify difference between 1.0 and 1.5 versions • Help you become aware of capital cycles
The Product • A comprehensive application of all required Heart Lung machine pumping systems, safety systems, and monitoring systems to sustain virtually all phases of extracorporeal support.
Customer Dynamics • There are currently three major suppliers of heart lung platforms (Sorin, Terumo, and Maquet) • These machines are typically in service up to ten years • Some customers / competitors will attempt to bundle with disposables • The introduction of Performer™ CPB is a major new leverage for Medtronic
A Strong Heritage from RanD • New OR Procedure Opportunities • Regional Cancer Therapies • Future ICU Based Therapies
RanDLocated in Europe’s “Medical Device Valley” • Sorin/ Dideco/ COBE HQ • Sorin-Bellco • B. Braun • Tyco-Mallinckrodt • Baxter-Miramed • Gambro-Hospal • Fresenius-Biofil
We Have Always Had The Ability To Invest In Today’s Legacy Technology From Solid-State To Microprocessor Controlled Technology Driven or in Support of Future Cardiac Surgery’s Needs?
Performer™ CPB • Compatible Today for All Procedures/ Built For The Future • All the Functionality of Existing Systems in the Smallest Footprint • Adaptable to New Disposable Configurations / Bringing the Circuit Closer to the Patient • Integrated Data Management Systems • Procedure Flexible & Feature Loaded
Performer ® CPB V1.0Resting Heart® • Based on Performer™ LRT Platform • Arterial Bio-Pump® • Designed to run RHS only • Integrated Active Air Removal; VARD software enabled • Optimized Safety Systems • Servo Mechanisms for VARD and Negative Venous Pressure • Variable Dosing (ratios) on Cardioplegia 15:1 • Standard items 3 timers, 8 Pressure and Temperatures • Sat Hct with in-vivo calibration • Transonic Flow Probe with bubble detection (ABD) • Electric Pump Height Adjustment • User Friendly Operation • Upgradeable • Competitively Priced
Performer ® CPB V1.5 Conventional - Future • Bio-Pump® Arterial Pump • Additional User Screen Configuration for Conventional Mode • Software (GUI) updates • New Remote Level Detectors; Upper and Lower • Servo Function Between Level and Bio-Pump® • Arterial Line Clamp to prevent retrograde flow • Settable Oxygen Sat and Hct limits with alerts • More dose specific CPG settings • Calculator • Data management
ConventionalVersion 1.5 Resting Heart® Version 1.0
Pump Systems 1 - 7.0 L/min Bio-Pump® Centrifugal Pump 1 - 3.7 L/min Max. Capacity Roller Pumps 1 - 1.5 L/min Max Capacity Roller Pumps 1 - 1.1L/min Max Capacity Roller Pumps 1 – 0.6 L/min Max Capacity Roller Pumps Meets your traditional requirements
User Friendly Interface • Intuitive Icon-based color display format • Alert/Alarm scrolling information bar • User-defined pump responses and alarms display • Supplemental information will not tile over operating screen For optimum control and convenience
Arterial Pump Systems Proven Bio-Pump® System • Preload / Afterload Sensitive optimum control • Tested and effective air handling and retention • Now with non-invasive flow probe and bubble detection • Now with servo control The tradition continues
Cardioplegia Options • Traditional One Pump • Fixed ratio double raceway • Two Pump Versatility • Slave control • Variable ratios on the fly • 1:1 to 15:1 options • Software interface for dosing and timing • Micro-plegia (Future) • Integrated syringe pump • Future activation (V 2.0) Greater adaptability and flexibility
Integrated Safety Systems 1 - AAR™ Venous Air Removal 8 - Pressure monitor/limiting devices 1 - Integrated SAT/Hct 1 - 3/8 inch arterial air detection device 1 - ¼ inch cardioplegia air detection device 8 - Temperature measurement inputs For more precise control and safety
Performer CPB Level Sensor • Impedance technology • Two Sensor Capable • Independently adjustable • User selectable Responses • Message only • Message and Coast • Alarm and Stop Flow • Optional Clamp capability
Arterial Clamp • Pneumatic Driven • Closed at Rest • User Selectable • Retro Flow • Stopped flow • Low Level • Bubble Detection • Optional Feature
Integrated Safety Systems • RHS Servo Control Options • Venous Line Pressure to flow • AAR to flow • Programmable pump responses • Pressure Monitor/shut off to each pump • Conventional Servo Options • Reservoir level to flow • Auto clamp options • Retro flow • Low level Greater stability of perfusion parameters
Data Management • Trending data display • Updates every minute • Records all critical parameters and settings • Data download capability • Compact Flash memory • RS232/RS485 output • Integral printer • Excel Macro • Report writer • Archival • Real Time Data Acquisition via External Program To better meet your latest requirements
Legacy Systems vs Performer™ CPB Performer CPB System One S 5
Virtual Part # P-CPB10 • Choose proper Rollers • Choose # of Temp Probes • Double Check Order • Change Quantities • Customize Table Pack • Start with CB4E96R5 • Need GV100
Performer™ CPB Timeline December 2004 • Functional Prototypes March 2006 • FDA 510K Clearance March 18th • Commercial Release March 31st 2006 September 2005 • CE Mark – 1st EU Human Cases Ongoing • 510K submission December 2006 • File FDA 510K for Version 1.5 Early 2007 • Expected Conventional Bio-Pump CPB Availability - Not available for sale
Summary • Version 1.0 is for Resting Heart only • Includes servo control of BioPump® to both: • Venous line pressure • Venous Air Removal Device (VARD) • Smallest footprint ever offered • Cardioplegia up to 15:1 ratios using 2 Pumps • Now in use in US ~450+ cases completed