Thoratec® Because There Are More Than Two Sides to the Story THORATEC CORPORATION

Products & Technology

Thoratec® Because there are more than two sides to the story THORATEC CORPORATION

THORATEC LABORATORIES AND THERMO CARDIOSYSTEMS

HAVE MERGED TO CREATE A NEW COMPANY OFFERING

SURGEONS, CARDIOLOGISTS AND HOSPITALS THE WIDEST

RANGE OF CIRCULATORY SUPPORT SOLUTIONS AVAILABLE

FOR THE TREATMENT OF CONGESTIVE HEART FAILURE.

Table of Contents

Introduction ...... 1

More Ways to Manage CHF...... 2

HeartMate® LVAS ...... 4

Thoratec® VAD System ...... 6

Thoratec Vascular Graft Products ...... 8

Support and Technology Resources ...... 10

ITC Products ...... 12 We offer the widest range of circulatory support solutions.

More than a Cardiac Assist Company

Cardiovascular diseases are the world’s leading cause of death. One of the most prevalent is Congestive Heart Failure (CHF). In the U.S. alone, an estimated five million people suffer from CHF, with another half-million or more diagnosed each year. The five-year mortality rate is estimated at 50 percent. Thoratec is committed to lowering that figure. In that effort, we provide two complementary cardiac assist product lines—the Thoratec Ventricular Assist Device (VAD) System for short-term cardiac support and the HeartMate Left Ventricular Assist System (LVAS) for longer-term support. Together, these products address more indications than the products of any other cardiac assist device company. Our cardiac assist products, along with our unique family of vascular grafts, our ITC blood coagulation measurement products, and a large and growing pipeline of next-generation devices in clinical trials or under development, make Thoratec a central resource for treatment offerings for cardiac surgeons, cardiologists and their patients. More Ways to Manage CHF

More than short-term heart failure assistance. Thoratec has a long-term vision.

Thoratec Ventricular Assist Devices

Approved Indications HeartMate IP HeartMate VE HeartMate ll*

Bridge to Transplant (BTT) Post-Cardiotomy Recovery (PC) Home Discharge

Potential Future Indications

Alternative to Transplant (ATT) Therapeutic Recovery (BTR) Home Discharge Bridge to Transplant

Product Attributes

Short-term Long-term Permanent Bi-VAD Mobility Small Patient Pneumatic Electric Pulsatile Axial Flow Centrifugal

* HeartMate II is not currently available in the U.S. and is under clinical investigation in Europe **HeartMate III is under development ***IVAD is an investigational device and is not available in the U.S. Congestive Heart Failure occurs when the heart becomes too weak to pump blood at a level sufficient to meet the body’s demand. This can be brought on by artery Ventricular Assist Devices, such as those offered by or valve diseases or a general weakening of the heart muscle Thoratec, are used today to support patients awaiting a itself. In addition, other symptoms, such as high blood heart transplant or recovering from open-heart surgery. pressure or diabetes, can lead to CHF. Future potential indications include therapeutic recovery The number of treatment options for CHF has increased in which the patient recovers the use of their natural heart over the years. The use of medication remains the most while being supported by a VAD, or permanent support widely used approach, including ACE inhibitors, anti-coag- in non-transplant candidates refractive to optimal ulants and beta-blockers which facilitate blood flow, thin medical management. the blood or help the heart work in a more efficient manner. The potential patient population is expected to grow Procedures used to treat CHF include angioplasty, valve because VADs can be used to treat some or all of the replacement, bypass and left ventricular reduction surgery. following indications: However, in many cases they provide only temporary relief. The most proven solution is heart transplantation. Bridge to Transplant (BTT) the most common use of However, the number of hearts available for transplant VADs, provides short and mid-term support for those each year can meet only a minimal portion of the demand. patients qualified to receive a heart transplant. At any given time, there are 4,000 or more people on the U.S. national transplant waiting list.

Post-Cardiotomy Recovery (PC) benefits from the use of VADs to treat patients recovering from open-heart surgery. Typically, the maximum time a patient can be supported by bypass equipment is six hours. A small percentage of patients who are unable to be weaned from bypass equipment after surgery require additional

HeartMate lll** Thoratec VAD IVAD*** TLC-II short-term VAD support.

Therapeutic Recovery (BTR) is the largest potential VAD indication, estimated at approximately $5 billion. While not yet an approved indication for circulatory support devices, clinicians estimate that a significant number of CHF patients can recover use of their natural hearts after being supported by a VAD. We are aware of approximately two dozen patients who have had that experience while supported by a Thoratec VAD System. We are currently pursuing FDA approval for this indication.

Alternative to Transplant (ATT) is the use of an implantable device to augment or replace the entire func- tion of the patient’s natural heart. We estimate the size of this market opportunity at up to 100,000 patients annually in the U.S. alone. More than a chance to live. A chance to live independently.

HeartMate LVAS

• THE LEADER IN LONG-TERM CARDIAC SUPPORT

• APPROVED FOR BTT SINCE 1994

• OVER 175 CLINICAL SITES WORLDWIDE

Alternative to Transplant (ATT) Since the mid-1990’s, the HeartMate LVAS and Thoratec Potential Patient Population (U.S.) VAD System have been used to treat more than 4,500 patients, accounting for about two-thirds of the cardiac assist market. That success is due, in part, to our ability to handle more of the short and long-term indications clinicians encounter every day. The HeartMate LVAS provides longer-term cardiac 100,000 POTENTIAL (ATT) support—to date over 900 cumulative patient years. Currently, two versions of the HeartMate LVAS are available:

2,000 CURRENT (BTT) • HeartMate IP, an air-driven system approved for bridge to transplant (BTT) in the U.S. and Europe since 1994, uses a blood pump coupled to an external console and Sources: 1999 NHLBI Report; Society of Thoracic Surgeons; Thoratec estimates connected to the body by a tube. HEARTMATE IP

THE FIRST FDA-APPROVED DEVICE FOR BTT, 1994. EXCLUSIVE TEXTURED SURFACES REQUIRE MINIMAL SYSTEMIC ANTICOAGULATION AND OFFER THE INDUSTRY’S LOWEST THROMBOEMBOLIC RATES, 3–6%.

HEARTMATE VE

THE WORLD’S MOST WIDELY USED IMPLANTABLE VAD. COMPLETE MOBILITY ALLOWS PATIENTS TO BE DISCHARGED FROM THE HOSPITAL WHILE AWAITING HEART TRANSPLANTATION. LVAS Products

HEARTMATE lll

CURRENTLY UNDER DEVELOPMENT, HEARTMATE II THE MINIATURE CENTRIFUGAL PUMP FEATURES A MAGNETICALLY A NEXT-GENERATION, MINIATURE LEVITATED BEARINGLESS MOTOR. AXIAL-FLOW VAD UNDER CLINICAL THIS DESIGN OFFERS THE POTEN- INVESTIGATION. DESIGNED TO TIAL OF SIGNIFICANTLY LONGER MEET THE NEED FOR A SMALLER, LIFE THAN EXISTING LVADS WITH RELIABLE DEVICE FOR LONG-TERM TRADITIONAL BEARINGS. CARDIAC SUPPORT.

• HeartMate VE, an electric LVAS, provides complete • HeartMate II is an implantable LVAS designed for longer- patient mobility. An electric motor inside the housing term support—five to seven years. With only one moving drives the pump and is connected by wires to an external part, automatic blood flow adjustment, 12-ounce weight battery pack. The HeartMate VE is FDA-approved for and D-cell battery size, it may be appropriate for smaller home discharge. patients. A European clinical trial is underway, and we anticipate launching a U.S. trial by the end of 2001. Thoratec is working with the National Institutes of Health and Columbia University to determine the HeartMate • HeartMate III represents highly advanced technology VE’s potential as an alternative to medical therapy, a market providing permanent support—up to 20 years. Advances opportunity of up to 100,000 patients annually in the U.S. include a miniature centrifugal pump, pulsatile flow and alone. The REMATCH (Randomized Evaluation of Mechanical state-of-the-art magnetic technology in which no moving Assistance for the Treatment of Congestive Heart Failure) components contact each other. We recently completed study will review the experiences of up to 140 patients. We six-month animal studies with favorable results. are pursuing approval in Japan, as well, and initiated a clinical trial in mid-2000. More than Bridge to Transplant. FDA approval for Post-Cardiotomy Recovery.

Thoratec VAD System

• FDA-APPROVED FOR LEFT, RIGHT OR BI-VENTRICULAR SUPPORT

• SATISFIES SHORT AND MID-TERM TREATMENT NEEDS

• OVER 1,700 PATIENTS TREATED

Therapeutic Recovery (BTR) The Thoratec VAD System is the only assist device Potential Patient Population (U.S.) approved by the FDA that offers left, right or biventricular support, as well as for both bridge to transplant (BTT) and post-cardiotomy recovery (PC). Because the system’s size and flexibility make it suit- able for the widest range of patients, it has been used to 160,000 POTENTIAL (BTR) support patients as young as six years old and weighing from 37–317 pounds. There are three major components: single-use blood pump; single-use cannulae, or tubing, that connect the blood pump to the heart and vessels; and a console that 2,000 CURRENT (BTT) drives the blood pump pneumatically. Typically, the Thoratec VAD System is used to support transplant candi- Sources: American Heart Association; Society of Thoracic Surgeons; Thoratec estimates THORATEC TLC-II

NOW FDA-APPROVED AND AVAILABLE WORLDWIDE. DRIVER WORKS WITH THORATEC VAD OR IVAD. INCREASED MOBILITY FOR PATIENTS. ALLOWS HOSPITALS GREATER DISCRETION TO DISCHARGE PATIENTS TO MEDICALLY SUPERVISED FACILITY.

THORATEC VAD SYSTEM

THE ONLY FDA-APPROVED VAD FOR BTT AND POST-CARDIOTOMY THORATEC IVAD SUPPORT. ALLOWS LEFT, RIGHT OR BI-VENTRICULAR SUPPORT IN HALF THE SIZE OF OTHER PATIENTS OF ALMOST ANY SIZE. IMPLANTABLE VADS. USES STANDARD VAD BLOOD PATH COMBINED WITH TITANIUM OUTER HOUSING. UNDER CLINICAL INVESTIGATION IN THE U.S. AND EUROPE.

VAD Products

dates for up to 60 days, while post-cardiotomy recovery System blood pump with a titanium outer housing suit- support can extend from a few hours to several months. able for implantation. At the end of 2000, we received conditional approval of an IDE for the IVAD and will The TLC-II®, a portable driver for the VAD System that initiate U.S. and European clinical trials in 2001. gives many patients the mobility they need to resume a nor- mal lifestyle, has been approved and is available worldwide. • Therapeutic Recovery (BTR), the largest potential application of VADs. Clinicians estimate many CHF Thoratec’s ongoing commitment is to continue to patients can recover use of their natural hearts after being develop new products and seek approval for new treat- supported by a VAD. We are aware of approximately ment indications. In keeping with that objective, we are two-dozen patients who have had that experience while currently investigating: being supported by the Thoratec VAD System. FDA • The IVAD, or Implantable VAD, which weighs only a approval for this indication is being pursued. pound and is half the size of competitive products. IVAD • The TLC-ll Portable VAD Driver for home discharge combines the internal components found in our VAD in the U.S. More than an aid for hemodialysis. Hope for bypass patients.

Thoratec Vascular Graft Products

• POTENTIALLY THE FIRST OFF-THE-SHELF CORONARY BYPASS GRAFT FOR PATIENTS WITH INADEQUATE NATIVE VESSELS

• VECTRA™ APPROVED IN U.S., EUROPE AND JAPAN

• DESIGNED FOR LESS PATIENT TRAUMA AND FEWER COMPLICATIONS

The overwhelming majority of patients suffering from kidney failure undergo hemodialysis. Easy and reliable access to the bloodstream is critical to the success of the treatment. Typically, this requires surgical implantation of a vascular access graft (VAG) connected between the APPROXIMATELY 200,000 patient’s artery and vein. Thoratec’s Vectra VAG is a small diameter graft PROSTHETIC VASCULAR ACCESS GRAFTS USED approved in major markets worldwide and the most FOR HEMODIALYSIS ARE IMPLANTED WORLDWIDE advanced device for this treatment. Patients implanted with Vectra can usually begin hemodialysis in as soon as within 24 hours, compared to several weeks for other technologies. In addition, the UP TO 180,000 OF PATIENTS UNDERGOING CORONARY ARTERY BYPASS SURGERY MAY HAVE INSUFFICIENT AUTOLOGOUS VESSELS

Aria CABG

POTENTIALLY THE FIRST OFF-THE- SHELF CABG FOR PATIENTS WITH INADEQUATE NATIVE BLOOD VES- SELS TO COMPLETE CORONARY REVASCULARIZATION. UNDER CLINICAL INVESTIGATION IN U.S.

Vascular Graft Products

Vectra VAG

FDA-APPROVED IN U.S. AND MAJOR MARKETS WORLDWIDE. ALLOWS EARLY ACCESS AND REDUCES HEMOSTASIS TIME.

device’s compliant, self-sealing design reduces bleeding Currently, no artificial graft has full approval or is being complications during and following the procedure. In marketed in the U.S. for this treatment. To date, the Aria has been many cases, it also reduces the amount of time required used in 19 patients in a Phase I clinical trial. for hemodialysis. Early data has been very encouraging and we expect to Our Aria™ coronary artery bypass graft (CABG) also move into a pivotal Phase II trial in 2001. This may well become presents a major opportunity to improve patient care. the surgeon’s first off-the-shelf graft option for patients with inad- Today, surgeons performing bypass surgery must harvest equate native vessels. natural vessels, an often traumatic and costly procedure We believe the value of our existing graft products can that can increase patient morbidity. And in many cases, be extended through next-generation devices, including the patient’s native vessels are of poor quality or limited in circulatory support and cardiovascular and vascular availability due to prior procedures. repair applications. Innovation from the industry’s strongest development team. And there’s more to come.

Support and Technology Resources

• TRACK RECORD OF BRINGING INNOVATION TO THE POINT OF TREATMENT

• UNIQUE, PROPRIETARY BLOOD CONTACTING MATERIALS AND SURFACES

• MORE THAN 100 EXPERIENCED ENGINEERS, SCIENTISTS, TECHNICIANS,

SALES STAFF AND SUPPORT PERSONNEL

Global Sales and Technical Support Thoratec has built a strong global sales, service and distribution system covering more than 22 countries, including extensive direct sales and clinical representation in the United States and Europe. Thoratec has specialists available for assistance with clinical and technical issues and advice on reimburse- ment. Thoratec has also developed programs to help physicians, nurses and staff learn about treating CHF using Thoratec products.

Clinical and Regulatory Affairs Thoratec built its reputation on the ability to bring circulatory support and vascular graft devices to market, and to execute the clinical trials that make it possible. HeartMate’s Sintered Titanium Textured Surface

AN EXCLUSIVE PROPRIETARY DESIGN, THESE SINTERED MICROSPHERES LINE THE TITANIUM SIDE OF THE BLOOD CHAMBER OF ALL HEARTMATE SYSTEMS. THIS TEXTURED BLOOD- CONTACTING SURFACE REDUCES THE RISK OF THROMBOEMBOLIC COMPLICATIONS FOR IMPROVED PATIENT OUTCOMES.

Thoralon® Support/Technology

A HIGHLY BIOCOMPATIBLE PROPRIETARY BIOMATERIAL THAT MINIMIZES CLOTTING AND INFLAMMATORY RESPONSES. THIS TECHNOLOGY IS CRITICAL TO THE SUCCESSFUL LONG-TERM PERFORM- ANCE OF THE THORATEC VAD, IVAD AND VASCULAR GRAFT PRODUCT LINE. Customer Support

EXPERIENCED SALES AND CLINICAL TEAM WORLDWIDE, INCLUDING DIRECT REPRESEN- TATION IN U.S. AND EUROPE.

Currently, Thoratec has 12 trials planned or underway To date, we have developed: in the U.S., Europe and Japan. We are sponsoring several • Unique proprietary blood contacting materials and studies in the U.S. and Europe to evaluate VADs for thera- surfaces. peutic recovery. We plan seven PMA supplements, one original IDE and 12 IDE supplements over the next year. • Seven Ventricular Assist Systems, including four FDA- We have developed significant in-house regulatory, approved, two entering clinical trials and one permanent clinical, statistical analysis and data management capabil- LVAS in development. ities to help ensure our continued ability to deliver the • Four Pulsatile Systems: three pneumatic and one electric. products patients need. • Two Rotary Pump Systems: one axial flow and one Research and Development centrifugal. Thoratec development is driven by a team of engineers, • The rights to over 50 patents on circulatory support scientists, and technicians with over 400 years of cumula- devices, biomaterials and vascular grafts. tive R&D experience in circulatory support. More than advanced CHF treatment for patients. A family of testing and monitoring systems.

ITC Products

ProTime® HEMOCHRON® POINT-OF-CARE MICROCOAGULATION WORLDWIDE LEADER IN BEDSIDE MONITORING SYSTEM APPROVED FOR COAGULATION TESTING. USE IN OFFICE, CLINIC OR AT HOME.

HEMOCHRON® Jr.

PATENTED MICRO-COAGULATION SYSTEM THAT REQUIRES JUST ONE DROP OF WHOLE BLOOD.

tenderfoot®

HEELSTICK DEVICE FOR ROUTINE INFANT BLOOD SCREENING. CREATES A VIRTUALLY PAIN-FREE INCISION IN THE INFANT’S HEEL.

For over 30 years, Thoratec’s ITC group has provided ITC’s ProTime System is a leading system worldwide for high quality testing and monitoring equipment for doctors patients taking blood-thinning drugs, such as Coumadin®. It and their patients undergoing coronary bypass, angioplasty is the first device FDA-approved for testing in a doctor’s and critical care procedures. It is a solid market leader. office, clinic or by patients themselves at home. ITC’s whole-blood coagulation systems, sold under The Company also offers a family of single-use skin inci- the HEMOCHRON and HEMOCHRON Jr. names, provide sion devices used to sample and test blood employing a bedside anticoagulation management, coagulation screen- patented skin incision technology. Surgicutt® devices are ing and transfusion management through the analysis of used to measure bleeding time. small blood samples. This is particularly important for The Tenderlett® is a finger stick incision device for patients who have undergone bypass surgery or angioplasty. blood collection, while the tenderfoot is a heel stick incision device designed specifically for blood collection from infants and small children. Patients for life™

Sales Information

Thoratec Corporation Thoratec Europe Limited ITC 6035 Stoneridge Drive 5 Brunel Court 8 Olsen Avenue Pleasanton, CA 94588 USA Burrel Road Edison, NJ 08820 USA 24-Hour Business: St. Ives, Cambridgeshire Tel: 732/548-5700 925/847-8600 PE27 3LW UK Fax: 732/632-9299 Customer Service: Tel: +44 (0) 1480-461866 www.itcmed.com 925/847-8600 Fax: +44 (0) 1480-461877 Toll Free: 800/528-2577 Fax: 925/847-8574 www.thoratec.com

Thoratec, HeartMate, the Thoratec logo, Thoralon, TLC-ll, HEMOCHRON, HEMOCHRON Jr., Surgicutt, Tenderlett, tenderfoot and ProTime are registered trademarks, and Vectra, Aria and Patients For Life are trademarks of Thoratec Corporation.

The statements in this document that relate to future plans, events or performance are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the merger with Thermo Cardiosystems and benefits thereof, government Creative, Inc. (Palo Alto, CA) ® regulatory approval processes and market acceptance of new products. These factors, and others, are discussed more fully under the heading “Risk Factors” in Thoratec’s 10-K for the fiscal year ended December 30, 2000, and other filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

6035 Stoneridge Drive

Pleasanton, California 94588

925 / 847-8600 fax 925 / 847-8574 www.thoratec.com www.itcmed.com