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TAXUS ® Express 2 ® Paclitaxel-Eluting Coronary Stent System Patient Information Guide

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Page 1: TAXU S Express - Boston Scientific · uncoated Express Stent, (6.9% forTAXUS Express Stent, 16.9% for Express Stent).The combined occurrence of Major Adverse Cardiac Events which

TAXUS® Express2®

Paclitaxel-Eluting Coronary Stent System

PatientInformation

Guide

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Table of ContentsCoronary Artery Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Who is at Risk? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Diagnosis of Coronary Artery Disease . . . . . . . . . . . . . . . . . . . . . 3

Treatment of Coronary Artery Disease . . . . . . . . . . . . . . . . . . . . . . . . 3Angioplasty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Coronary Artery Stents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Restenosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Your Drug-Eluting Stent, the TAXUS® Express2® Paclitaxel-ElutingCoronary Stent System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Drug-Eluting Stents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7The Express® Stent Platform for the TAXUS® Express® Stent. . . . 7The Polymer Coating on the TAXUS Express Stent. . . . . . . . . . . 7The Drug that is Released from the TAXUS Express Stent . . . . . 8When should the TAXUS Express Stent NOT be Used . . . . . . . . 8What are the Risks & Potential Benefits of Treatmentwith the TAXUS Express Stent? . . . . . . . . . . . . . . . . . . . . . . . . . . 9Alternative Practices and Procedures . . . . . . . . . . . . . . . . . . . . . 11

The Angioplasty Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Preparation for the Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . 12Angioplasty and Stent Placement Procedure. . . . . . . . . . . . . . . . 12

Post-Treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13After the Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Follow-Up Examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Magnetic Resonance Imaging (MRI) . . . . . . . . . . . . . . . . . . . . . 15

Frequently Asked Questions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Patient Information Card. . . . . . . . . . . . . . . . . . . . . Inside Back Cover

Notes

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Coronary Artery DiseaseCoronary Artery Disease (CAD) is usually caused by atherosclerosis, andaffects the coronary arteries that surround the heart. These coronaryarteries supply blood with oxygen and other nutrients to the heartmuscle to make it function properly. CAD occurs when the innerwalls of the coronary arteries thicken due to a buildup of cholesterol,fatty deposits, calcium, and other elements. This material is known asplaque. As plaque develops, the vessel narrows. When the vesselnarrows (for examplewith physical exertionor mental stress),blood flow throughthe vessel is reducedso less oxygen andother nutrients reachthe heart muscle.This reduced bloodflow may cause mildto severe chest painsor chest pressure. Thispain or pressure canalso spread to the armsor jaw, a conditionknown as anginapectoris. Completeobstruction (no bloodflow) of a coronaryartery can result in aheart attack (myocardial infarction).

Anyone who experiences symptoms of angina pectoris or myocardialinfarction should promptly seek medical care.

Over 13 million Americans suffer from CAD each year. However,treatment options for CAD have substantially improved in recentyears, and many CAD patients are now able to return to a normallifestyle shortly after treatment.

Notes

2

RightCoronary

Artery

PosteriorDescending

Artery

CircumflexArtery

LeftAnterior

DescendingArtery

Aorta

LeftCoronary

Artery

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Who is at Risk?People with a history of high cholesterol, diabetes, smoking, highblood pressure, being overweight and a family history of CAD have anincreased risk of developing atherosclerosis in the coronary arteries.Increasing age adds to the risk of CAD. In addition, menopausal statusmay play a role in women.

Diagnosis of Coronary Artery DiseaseDoctors may use various tests to diagnose CAD. An electrocardiogram(ECG or EKG) measures your heart’s electrical activity and may showwhether parts of your heart muscle have been damaged by a heartattack due to CAD. A stress test records your heart’s electrical activitywhile you are exercising and may tell your doctor whether part of yourheart muscle is damaged. A coronary angiogram is a procedure performedby a cardiologist in a Cardiac Catheterization Lab. This procedure isdone by injecting a contrast dye into the coronary arteries so that thevessels can be seen on an x-ray screen. The angiogram will show if anyblockages and/or artery narrowing has occurred. This will help yourdoctor decide how to treat you.

Treatment of Coronary Artery DiseaseCAD may be managed through a combination of changes in lifestyleand physical activity, diet, and medical treatment. The therapy yourdoctor recommends will depend on the condition and severity of thedisease. Nitroglycerin is often given to relieve chest discomfort due toblockages, but does not treat the blockage itself. Medical treatments ofthe blockage may include medications, angioplasty, with or withoutstent placement, or coronary artery bypass graft surgery (CABG).

Notes

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AngioplastyAngioplasty is a minimally invasive treatment of the coronary arteriesperformed in the hospital to open blocked arteries, also knownas percutaneous transluminal coronary angioplasty (PTCA). A thintube known as a catheter is inserted through the groin or wrist andis then threaded through a major blood vessel to the site of theblockage. A small balloon, located on the tip of the catheter, is thenexpanded to reduce the blockage. PTCA can be performed with aballoon alone, or can involve the placement of a coronary stent.

Coronary Artery StentsCoronary artery stents are devices that can help to reducethe risk of recurrent blockage or narrowing following anangioplasty procedure. Stents are small expandable metaltubular structures (lattice) that are implanted into a vesseland expanded to fit the size, shape, and bend of the vesselwall, propping it open to help prevent further blockages.Once in place, the stent will remain in your artery. Overtime, the artery wall will heal around the stent as itcontinues to support the vessel.

Plaque BeforeTreatment

Balloon AngioplastyProcedure

Result AfterAngioplasty

Plaque BeforeTreatment

StentProcedure

Result After StentProcedure

Notes

Side View of Coronary Artery

Artery

Plaque

Stent

Balloon

Catheter

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RestenosisMany patients who undergo balloon angioplasty treatment willexperience a renarrowing of the artery, or restenosis, in the area thatwas being treated. The rate of restenosis is between 30 and 50 percentfor angioplasty patients who do not receive a stent within the first sixmonths after their initial procedure. The renarrowing can be causedby a combination of factors including vessel recoil and formation oftissue ingrowth in the treated area.

Notes

RestenosisNarrows TreatedVessel Over Time(Initial Artery Size

Plus TissueIngrowth)

Coronary ArteryDisease (InitialArtery Size withTypical Plaque)

After Expansionby Balloon

Angioplasty—Plaque Pushed

Back. Artery WallStretches

Vessel Recoil(Stretched VesselNaturally Returns

to Initial Size)

Cross-Section of Coronary Artery

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Although coronary artery stents have proven to reduce the occurrenceof restenosis compared to balloon angioplasty, restenosis still occurs inapproximately 10 to 30 percent of patients who receive bare metal stents.Unlike restenosis after balloon angioplasty, restenosis in a stent (in-stentrestenosis) is not typically associated with vessel recoil. Instead, in-stentrestenosis primarily results from increased tissue ingrowth.

Notes

RestenosisNarrows

Treated VesselOver Time

(Initial ArterySize Plus Tissue

Ingrowth)

Coronary ArteryDisease

(Initial ArterySize with Typical

Plaque)

After Expansionby Balloon

Angioplasty withStent PlaquePushed Back.Artery WallStretches

Stent Strut

Stent PreventsStretched Vesselfrom Recoiling to

Initial Size

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Your Drug-Eluting Stent, the TAXUS® Express2® Paclitaxel-Eluting Coronary Stent System

Drug-Eluting StentsA drug-eluting stent is a bare metal stent that has been coated with a drug and a polymer. Drug-elutingstents are designed to deliver a drug locally to reduce tissue ingrowth.

*Note: A green color is used to show coating but actual coating is clear

The Express Stent Platform for the TAXUS Express StentThe Express Stent, the small steel tube upon which the drug/polymer coating is applied, has been usedextensively as a bare metal stent and is very flexible, allowing it to conform to the natural curves of your artery.

The Polymer Coating on the TAXUS Express StentThe stent is coated with a proprietary polymer (a chemical compound) called Translute™, which wasdeveloped specifically for the TAXUS Express Stent. The Translute Polymer is also known as SIBS[poly(styrene-b-isobutylene-b-styrene)]. The polymer carries and protects the drug before and during theprocedure. Then, once the stent is implanted in the coronary artery, it helps control drug release into thearterial wall. This contributes to even and consistent distribution of the drug from the stent.

Schematic ofExpress® Stent

Cross Section of a coated stent to point out how coatingconforms to the surface of the bare metal stent

Schematic ofTAXUS® Express® Stent*

Drug(Paclitaxel)

PolymerCoating

(Translute™)

StentStrut

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The Drug that is Released from the TAXUS® Express® StentThe TAXUS Express Stent was designed by coating the Express® Stentwith the drug paclitaxel, and the polymer. The paclitaxel/polymercoating has been designed to allow for a consistent and controlledrelease of the drug from the stent surface into the artery walls, tominimize release into the blood stream. Both the amount of drug andrelease rate have been determined so that healing can occur whileallowing the processes leading to restenosis to be minimized, thusreducing the need for additional treatment in the stented area.

The TAXUS Express Stent uses a very small but effective doseof paclitaxel, which is released slowly over the time period whenrestenosis is most likely to occur. Some paclitaxel will remain onthe stent, with no additional measurable amount being releasedinto the body.

NOTE: Paclitaxel is also available in injection form, known by thetrade name Taxol®, and is also available in generic formulations.Let your doctor know if you are currently using this drug.

When should the TAXUS Express Stent NOT be Used?(Contraindicated)• If you have an allergy to the drug paclitaxel or structurally relateddrugs, or to the SIBS polymer.

• If you cannot take aspirin or blood-thinning medications (also calledantiplatelets or anticoagulants).

• If the physician decides that the blockage will not allow completeinflation of the angioplasty balloon or proper placement of the stent.

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Notes

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What are the Risks & PotentialBenefits of Treatment with theTAXUS® Express® Stent?

Potential adverse events, whichmay be associated with theimplantation of a coronarystent, include:

• air, tissue, or clots which canblock the vessel (emboli)

• allergic reaction to the contrastdye (which could includekidney failure)

• allergic reaction to the metalused to make the stent(stainless steel)

• aneurysm

• bleeding that would require ablood transfusion

• bruising whichresides on a blood vessel(pseudo-aneurysm)

• chest pain or discomfort

• collection of blood in thelining of the heart

• coronary spasms

• death

• emergency bypass surgery

• heart attack

• high or low blood pressure

• inadequate supply of bloodto the heart

• infection and/or pain at theaccess site

• injury or tearing of blood vessel

• irregular heart beat (arrhythmia)

• movement of the stent asit is sliding from the ballooninto the blood vessel(embolization)

• plugging of the stent withblood clots

• renewed formation of anarrowing in the treatedvessel (restenosis)

• side effects due to contrast dyeor heparin

• shock/pulmonary edema

• stroke or other neurologicalevents

• total occlusion of the vessel

• unnatural connection betweenvein and artery (arterio-venousfistula)

• vessel trauma requiring surgicalrepair or reintervention

• worsening of heart andlung function

Notes

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Potential adverse events relatedto the drug paclitaxel (basedon studies of patients whoused the drug for a prolongedperiod of time) or the polymerinclude:

• abnormal liver values

• allergic or immunologicreaction to the drug (paclitaxel)

• allergic reaction to the polymer[Translute™: poly(styrene-b-isobutylene-b-styrene)] orpolymers with similar chemicalstructures

• anemia

• blood transfusion

• changes in blood profile(decrease of white and redblood cells and platelets)

• changes of the tissue in thevessel wall includinginflammation, cell injury,and cell death

• disturbances of thegastrointestinal (GI)tract and stomach

• loss of hair

• muscle pain/joint pain

• nerve disease in arms and legs

There may be other potentialadverse events that are unforeseenat this time.

Exposure to paclitaxel andthe polymer coating is directlyrelated to the number ofimplanted stents. Use of morethan one TAXUS® Express®

Stent has not been adequatelyevaluated. Use of multiple stentswill result in your exposure toa larger amount of paclitaxeland polymer coating thanexperienced in the clinicalstudies.

There is no clinical experienceon the performance of theTAXUS Express Stent beforeor after use of brachytherapy, orwhen used with other types ofcoated or drug-eluting stents.

Notes

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NotesThe safety and effectiveness of the TAXUS® Express® Stent wascompared to the Express® Stent (an uncoated stent) in the TAXUS IVtrial that included 1,314 patients. All patients were followed for 1year. The study results showed that patients who received a TAXUSExpress Stent had a significantly lower incidence of repeat proceduresin the vessel where the stent was placed, when compared to theuncoated Express Stent, (6.9% for TAXUS Express Stent, 16.9% forExpress Stent). The combined occurrence of Major Adverse CardiacEvents which is comprised of death, heart attacks, bypass surgery, andrepeat angioplasty was 10.7% for TAXUS Express Stent patients and20% for Express Stent patients.

The study showed the risks associated with the TAXUS Express Stentare equivalent to the risks associated with the uncoated Express Stent.

Long term risks and benefits (i.e., greater than one year) associatedwith the TAXUS Express Stent are currently unknown.

Alternative Practices and ProceduresTreatment of patients with coronary artery disease including in-stentrestenosis may include exercise, diet, drug therapy, percutaneouscoronary interventions (such as angioplasty, bare metal stents, coatedstents, and other drug eluting stents), and coronary artery bypass surgery.

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Notes The Angioplasty Procedure

Preparation for the ProcedureYour doctor will instruct you on how to prepare for the angioplastyprocedure and stent implantation procedure prior to being admittedto the hospital. Your doctor may ask you to take aspirin and otherprescribed medications for several days before the procedure. This isdone to “thin” the blood to prevent blood clots from forming duringthe procedure. It is important to tell your doctor if you cannot takeaspirin or have a history of bleeding problems. Your doctor also needsto know if you are taking any other medications, have drug allergies,or are allergic to any metals or plastics.

Angioplasty and Stent Placement ProcedureYour angioplasty procedure will be performed in a specially equippedarea of the hospital called the Cardiac Catheterization Laboratory. Youwill have to lay flat on your back during the procedure and you willremain awake, allowing you to follow your cardiologist’s instructions(e.g., “breathe deeply”). Your groin or arm will be shaved and cleanedwith antiseptic and you will be given a local anesthetic to numb the area.

Your cardiologist will place an introducer sheath either in your groin orin your arm to gain access to the artery. The sheath enables thecardiologist to slide a small guiding catheter up to the entrance of thecoronary artery. Through the guiding catheter, a contrast dye will beinjected that helps the doctor see the coronary arteries on the x-raymachine. A finer guide wire is then advanced through the guidingcatheter to the stenosis, or blockage, in the diseased artery. Thisprovides the “railway track” which carries all the equipment necessaryfor the procedure.

Using the guiding catheter, a balloon catheter is then positionedprecisely in the clogged area of the coronary artery. Once in place, theballoon is inflated, compressing the plaque buildup and widening theartery. At this time you may experience some chest pain. Althoughthis is normal, let your doctor know if you are experiencing any pain.

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After the artery has been widened, your doctor will then pass thestent, mounted on a delivery catheter, into the coronary artery wherethe balloon was inflated. Your doctor will again inflate the balloon toexpand the stent and deliver it to the inner wall of the artery. Thestent will expand to shape itself to the size and contours of your vessel.

Your doctor may choose to expand the stent further by using anotherballoon. If required, the balloon catheter is inserted inside the stentand then inflated to help the stent make better contact with the arterywall. This part of the procedure is called post-dilatation. Post-dilatationis done to enable full contact of the stent to the artery wall. Oncein place, the TAXUS® Express® Stent will remain as a permanentimplant in your artery. The TAXUS Express Stent uses a very smallbut effective dose of paclitaxel, which is released slowly over the timeperiod when restenosis is most likely to occur. Some paclitaxel willremain in the stent, with no additional measurable amount beingreleased into the body.

POST-TREATMENT

After the ProcedureAfter the stent is implanted, you will be moved to a cardiology wardfor a short period where you can be monitored closely as you begin torecover. On average, your hospital stay may last one to three daysbefore you are discharged.

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Notes

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Activity• Follow your doctor’s guidelines.

• Return to normal activities gradually, pacing your return to activityas you feel better. Check with your doctor about strenuous activities.

• Let your doctor know about any changes in lifestyle you makeduring your recovery period.

• Report side effects from medications immediately. These mayinclude headaches, nausea, vomiting, or rash.

• Do not stop taking your medications unless you are asked to stop bythe doctor who implanted your stent.

• Keep all follow-up appointments, including laboratory blood testing.

• Carry your Patient Information Card (provided in the back of thisbooklet) at all times. If you receive dental or medical care or reportto an emergency room/center, show your Patient Identification Card.

MedicationsYour cardiologist may prescribe a number of medications to thin theblood and prevent blood clots from forming and adhering to thesurface of the stent. You will be asked to take a small daily dose ofaspirin indefinitely. In addition, your treatment regimen will includeeither clopidogrel (Plavix®) or ticlopidine (Ticlid®) for a period of6 months in combination with aspirin. It is extremely important tofollow your medication regimen. If you stop taking these medicationsbefore being instructed to do so by your cardiologist, the chancesof blood clot formation on the stent, subsequent heart attack oreven death, are increased.

If you plan to have any type of surgery or dental work which mayrequire you to stop taking these medications prematurely, you andyour cardiologist should discuss whether or not placement of adrug-eluting stent is the right treatment choice for you.

Notes

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If surgery or dental work which would require you to stop taking thesemedications prematurely is recommended after you’ve received thestent, you and your doctors should carefully consider the risks andbenefits of this additional surgery versus the possible risks from earlydiscontinuation of these medications.

If you do require premature discontinuation of these medicationsbecause of significant bleeding, then your cardiologist will be carefullymonitoring you for possible complications. Once your condition hasstabilized, your cardiologist will possibly put you back on thesemedications.

Follow-Up ExaminationsYou will need to see the doctor who implanted your stent for routinefollow-up examinations. During these visits, your doctor will monitoryour progress, evaluate your medications, check the clinical status ofyour CAD, and ask how the stent is working for you.

Magnetic Resonance Imaging (MRI)If you require a magnetic resonance imaging (MRI) scan, tell your doctoror MRI technologist that you have a stent implant. Test results indicatethat the TAXUS® Express® Stent is MR Conditional. Patients withsingle or overlapped TAXUS Express Stents can undergo MRI scanssafely under the following conditions:

• Static magnetic field of 1.5 or 3 Tesla

• Spatial gradient field of 700 Gauss/cm or less

• Normal operating mode (maximum whole-body-averaged specificabsorption rate (SAR) of 2.0 W/kg) for 15 minutes or less of scanning

The stent(s) should not migrate in this MRI environment, and MRImay be performed immediately following the implantation of a TAXUSExpress Stent(s).

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Notes

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FREQUENTLY ASKED QUESTIONS

Can I undergo MRI or scannertesting with a stent?MRI safety testing has shownthat the TAXUS® Express® Stentis MR Conditional and that apatient with a TAXUS ExpressStent may safely undergo an MRIscan under certain conditionslisted on the patient implant card.Prior to undergoing an MRI scan,inform your doctor or MRtechnologist that you have aTAXUS Express Stent.

Can the stent move or rust?Once positioned by yourphysician, the stent doesnot move on its own. It ismanufactured so it willnot rust.

Can I walk through metaldetectors with a stent?Yes, without any fearof setting them off.

How soon can I goback to work?The majority of people returnto work within a few daysfollowing the procedure.

What if I still get pains?If you experience pain, informyour cardiologist or the centerwhere the procedure wasperformed immediately.

Can I play sports?Yes, but be cautious! Your doctorwill tell you what sports you canplay and when you can start them.

What should Ichange in my diet?Your doctor may prescribe alow-fat, low-cholesterol diet tohelp reduce the levels of fat inyour blood and reduce your risk.

Does paclitaxel have any druginteractions that I should beconcerned about?Formal drug interaction studieswith paclitaxel after use of aTAXUS Express Stent havenot been conducted. Since somepaclitaxel will remain on thestent, interactions at the locationof the stent itself affecting theperformance of the drug cannotbe ruled out. Be sure to discusswith your doctor any drugs youare taking or planning to take.

What if I have taken paclitaxelbefore for cancer treatmentand had a reaction to it?Be sure to let your doctor knowif you have had a previousallergic reaction to paclitaxel.

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Notes

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GLOSSARY

Angina Pectoris Symptomsexperienced when the heart muscleis not receiving adequate oxygen(may include chest, arm or back pain,shortness of breath, nausea, vomiting).

Angiogram X-ray of the heart usingcontrast dye injection.

Angioplasty A minimally invasivetreatment of the coronary arteries,to open blocked arterial vessels. Alsoknown as percutaneous transluminalcoronary angioplasty (PTCA).

Atherosclerosis A disease in which theflow of blood to the heart is restrictedwith plaque deposits and, therefore,less oxygen and other nutrients reachthe heart muscle. This may lead tochest pain (angina pectoris) or to aheart attack (myocardial infarction).

Balloon Angioplasty Opening theblocked artery by using a ballooncatheter that is inflated inside the vessel.

Brachytherapy The use of a locallydelivered dose of radiation to controlthe process of restenosis.

Catheter A small, thin plastic tubeused to provide access to parts of thebody, such as the coronary arteries.

Coronary Angiogram A test in whichcontrast dye is injected into thecoronary arteries and allows the doctorto see the vessels on an x-ray machine.

Coronary Arteries The arteries thatsurround the heart and supply bloodcontaining oxygen and nutrients tothe heart muscle.

Coronary Artery Bypass GraftSurgery (CABG) Open heart orbypass surgery.

Coronary Artery Disease (CAD)Disease affecting the coronary arteriesthat surround the heart and supplyblood to the heart muscle. CADoccurs when the lumen of the coronaryarteries becomes narrowed with plaquedeposits (a buildup of cholesterol andother fats, calcium and elementscarried in the blood).

Electrocardiogram (ECG/EKG)A test that records changes in theelectrical activity of the heart. Mayshow whether parts of the heart musclehave been damaged due to insufficientoxygen flow to the heart.

In-Stent Restenosis Recurrentblockage or narrowing of a previouslystented vessel.

Introducer Sheath A tube that isinserted into the body to provide anaccess point and allow the insertionof other instruments into the artery.

Lumen The inner channel of a vessel.

Magnetic Resonance Imaging(MRI) A non-invasive way to takepictures of the body. MRI usespowerful magnets and radio waves,unlike x-rays and computedtomographic (CT) scans whichuse radiation.

Myocardial Infarction Permanentdamage to the heart tissue and muscledue to the interruption of the bloodsupply to the area. Commonly referredto as a heart attack.

Percutaneous TransluminalCoronary Angioplasty (PTCA)See Angioplasty.

Plaque Accumulation or buildupof cholesterol, fatty deposits, calciumand collagen in a coronary vessel thatleads to blockages in the blood vessel.

Post-Dilatation After the stent hasbeen expanded, another ballooncatheter may be inserted inside thestent and inflated to size the stentmore precisely to the wall.

Restenosis Recurrent blockage ornarrowing of a previously treatedvessel.

Stent An expandable metal tubularstructure (lattice) that supports thevessel wall and maintains blood flowthrough the opened vessel.

Stress Test A test that records theheart’s electrical activity while thepatient exercises. May show whetherparts of the heart muscle have beendamaged due to insufficient oxygenflow to the heart.

Vessel Recoil When an artery isstretched during an angioplastyprocedure, the elastic properties ofthe coronary vessel wall may causethe vessel to “shrink back” afterthe procedure.

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StentImplantLocation

TAXUS®Express2®Paclitaxel-Eluting Coronary Stent System

Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760-15371.888.272.1001www.bostonscientific.comwww.stent.com© 2009 Boston Scientific Corporationor its affiliates. All rights reserved.

90511524-01 JUL09

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StentIdentificationInformation

PatientName

ImplantingPhysician’sName

Physician’sPhoneNumber

ProductName

ProductLotNumber

StentLocation

PatientPhoneNumber

StentMaterial

DateofImplant

ProductName

ProductLotNumber

StentLocation

TAXUS®

Express2®

CoronaryStentSystem

Ifyourequireamagneticresonanceimaging(MRI)scan,tellyourdoctororMRI

technologistthatyouhaveaTAXUSExpressStent.TestresultsindicatethattheTAXUS

ExpressStentisMRConditional.PatientswithsingleoroverlappedTAXUSExpress

StentscanundergoMRIscanssafelyunderthefollowingconditions:

•Staticmagneticfieldof1.5or3Tesla

•Spatialgradientfieldof700Gauss/cmorless

•Normaloperatingmode(maximumwhole-body-averagedspecificabsorptionrate(SAR)of2.0W/kg)for15minutesorlessofscanning

Thestent(s)shouldnotmigrateinthisMRIenvironment,andMRImaybeperformed

immediatelyfollowingtheimplantationofaTAXUSExpressStent(s).

MRimagequalitywillbecompromisediftheareaofinterestisinthesameareaor

relativelyclosetothepositionofthestent.Pleasecontact1.888.272.1001formore

informationaboutMRimageartifact.

Pleasecarryyourcardatalltimes.

Yourcardiologisthasprescribedanumberofmedicationstothinthebloodandprevent

bloodclotsafteryourimplant.Itisextremelyimportanttofollowthemedication

regimenasprescribedbyyourcardiologist.Beforeconsideringanysurgeryordental

workwhichwouldrequireyoutostoptakingthesemedicinesearly,youandyour

doctorsshouldconsidertherisksfromprematurediscontinuationofthesemedications.

ForquestionsregardingyourCoronaryStentSystemorotherprocedures,please

contactyourimplantingcardiologist.

Page 21: TAXU S Express - Boston Scientific · uncoated Express Stent, (6.9% forTAXUS Express Stent, 16.9% for Express Stent).The combined occurrence of Major Adverse Cardiac Events which

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Indications, contraindications, warnings and instructions for use can be found inthe labeling supplied with each product. CAUTION: Federal (U.S.A.) law and governinglaw outside the U.S.A. restricts these products to sale by or on the order of aphysician. TAXUS® Express2® Paclitaxel-Eluting Coronary Stent System is a productof Boston Scientific Corporation.

Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760-15371.888.272.1001www.bostonscientific.comwww.stent.com

© 2009 Boston Scientific Corporationor its affiliates. All rights reserved.

Taxol is a trademark of Bristol-Myers SquibbCompany. Plavix and Ticlid are trademarksof Sanofi-Aventis Corp.

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