Performer® CPB

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

RanD Located 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 V1.0 Resting 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

Resting Heart® Version 1.0 Conventional Version 1.5

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 Two Pump Versatility 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 Data download capability 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

Size Does Matter …In Hospital Operating Rooms

Legacy Systems vs Performer™ CPB System One S 5

Virtual Part # P-CPB10 Double Check Order Customize Table Pack 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 September 2005 CE Mark – 1st EU Human Cases Ongoing 510K submission March 2006 FDA 510K Clearance March 18th Commercial Release March 31st 2006 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