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

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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-genera- tion 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,
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