I N T E R M E D I AT E O R G R E AT E R R I S K
`
`Transcatheter
`Aortic Valve
`Replacement
`
`with the Edwards SAPIEN 3
`Transcatheter Heart Valve
`
`For Patients & Caregivers
`
`Page 1 of 11
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-01293 U.S. Patent 8,992,608
`Exhibit 2001
`
`

`

`This patient booklet is for those who
`are suffering from severe aortic
`stenosis and are at intermediate or
`greater risk for surgical aortic valve
`replacement. This information will
`help you learn more about your heart,
`aortic stenosis and your treatment
`options, including a less invasive
`procedure called transcatheter aortic
`valve replacement (TAVR).
`
`Be sure to ask your specialized Heart
`Team to explain all of your treatment
`options and the possible risks and
`benefits of each.
`
`2
`
`This booklet is not intended to
`explain everything you need to
`know about your treatment
`options for aortic stenosis, or
`about the TAVR procedure. Please
`discuss any questions you have
`with your doctor. Only a
`specialized Heart Team can
`decide which treatment option
`is right for you.
`
`Table of Contents
`Your Heart Valves .....................................................................................................................................................................................................3
`
`What is Severe Aortic Stenosis? .........................................................................................................................................................4
`
`
`
`Factors Associated With Aortic Valve Disease .........................................................................................................................4
`
` What Are the Symptoms of Aortic Stenosis ................................................................................................................................4
`
`Understanding Your Treatment Options for Severe Aortic Stenosis .....................................5-6
`
`
`
`
`
`Surgery ..............................................................................................................................................................................................................................................................5
`
`Transcatheter Aortic Valve Replacement (TAVR) ...............................................................................................................6
`
`Edwards SAPIEN 3 Transcatheter Heart Valve ......................................................................................................8-12
`
` What Do You Need to Do Before the Procedure? ............................................................................................................9
`
`
`
`Transfemoral Approach ........................................................................................................................................................................................9-10
`
` What Happens After the Procedure? ...................................................................................................................................................11
`
` What Are the Benefits of TAVR? ......................................................................................................................................................................12
`
`
`
`How Long Will My Valve Last?............................................................................................................................................................................12
`
`Clinical Data for Intermediate-Risk Patients .....................................................................................................13-14
`
`TAVR 30-day and 1-year Clinical Outcomes .............................................................................................................................13
`
`
`
`Surgery 30-day and 1-year Clinical Outcomes ....................................................................................................................14
`
`Clinical Data for High-Risk and Inoperable Patients .........................................................................................15
`
`TAVR 30-day and 1-year Clinical Outcomes ..................................................................................................................................15
`
`What Are the Risks of TAVR? ................................................................................................................................................................16
`
`Precautions....................................................................................................................................................................................................................18
`
`Warnings ........................................................................................................................................................................................................................18
`
`Who Should Not Have the Procedure? ................................................................................................................................18
`
`Contact Information ........................................................................................................................................................................................19
`
`Page 2 of 11
`
`

`

`YOUR HEART VALVES
`The heart is a muscular organ in your
`chest that is about the size of your fist.
`The heart’s main function is to pump
`blood to the rest of your body. Each
`valve usually has two or three leaflets
`(flaps of tissue) that open and close like
`gates to regulate the one-way flow of
`blood through the heart.
`
`It is important that your valves are
`always working properly:
`• Be properly formed and flexible
`• Should open all the way so that the right
`amount of blood can pass through
`• Close tightly so that no blood leaks
`back into the chamber
`
`There are two problems that can
`occur in heart valves:
`
`Stenosis: when your valve narrows
`and does not open completely
`
`Regurgitation: when your valve does
`not close completely and blood can
`leak backwards
`
`RIGHT
`ATRIUM
`
`Aortic
`valve
`
`Tricuspid
`valve
`
`LEFT
`ATRIUM
`
`Mitral valve
`
`Pulmonary
`valve
`
`RIGHT
`VENTRICLE
`
`LEFT
`VENTRICLE
`
`WHAT IS SEVERE
`AORTIC STENOSIS?
`Aortic stenosis can be caused by a
`birth defect, rheumatic fever, radiation
`therapy or can be related to age. In
`elderly patients, severe aortic stenosis
`is sometimes caused by the build-up
`of calcium (mineral deposits) on the
`aortic valve’s leaflets. Over time the
`leaflets become stiff. This reduces their
`ability to fully open and close. When
`the leaflets don’t fully open, your heart
`must work harder to push blood
`through the aortic valve to your body.
`As a result, less oxygen-rich blood
`flows from the lungs to the brain and
`rest of the body, which may cause
`symptoms. It’s important to know that
`heart valve disease may occur with no
`outward symptoms.
`
`Severe aortic stenosis is a very
`serious problem. Approximately
`50% of the people who develop
`symptoms will die within an
`average of 2 years without aortic
`valve replacement.
`
`Factors Associated With
`Aortic Valve Disease
`• Increasing age
`• High blood pressure
`• High cholesterol
`• Smoking
`
`What Are The Symptoms
`of Aortic Stenosis
`• Chest pain
`• Fatigue
`• Shortness of breath
`• Lightheadedness, feeling dizzy,
`and/or fainting
`• Difficulty when exercising
`The symptoms of aortic stenosis are
`commonly misunderstood by
`patients as ‘normal’ signs of aging.
`
`HEALTHY AORTIC VALVE
`
`Closed
`
`Open
`
`DISEASED AORTIC VALVE
`
`Closed
`
`Open
`
`If you suspect any change in your ability to perform routine
`daily activities, consult your cardiologist right away.
`
`3
`
`4
`
`Page 3 of 11
`
`

`

`UNDERSTANDING YOUR
`TREATMENT OPTIONS
`FOR SEVERE AORTIC
`STENOSIS
`If you have been diagnosed with
`severe aortic stenosis and your
`doctor has evaluated you to be
`at intermediate or greater risk
`for surgery, TAVR may be a better
`alternative for you. However,
`only a specialized Heart Team
`can determine which treatment
`option is best for you.
`
`Surgery
`Most open heart surgeries are performed
`through an incision across the full
`length of the breast bone, or sternum.
`This incision is called a median
`sternotomy. Occasionally open heart
`surgeries can be performed through
`smaller incisions.
`
`Open heart surgeries, including those
`performed through smaller incisions,
`both require the use of a heart lung
`machine which temporarily takes over
`the function of the heart. During the
`procedure, the surgeon will completely
`remove the diseased aortic valve and
`insert a new valve. There are two
`different types of surgical valves:
`• Mechanical (man-made material)
`• Biological (animal or human tissue)
`
`For more information
`on treatment options,
`please visit
`
`Transcatheter Aortic Valve
`Replacement (TAVR)
`TAVR is a less invasive, catheter-based
`technique for replacing the diseased
`aortic valve. An interventional
`cardiologist along with a cardiothoracic
`surgeon will work together in the TAVR
`procedure. They will guide a new valve
`into the heart through an incision in
`the leg while the heart is still beating,
`using guidance from X-ray and
`echocardiography.
`
`5
`
`6
`
`Page 4 of 11
`
`

`

`EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
`The Edwards SAPIEN 3 transcatheter heart valve is a biological tissue valve that will
`replace your diseased aortic valve. It is available in four sizes, 20, 23, 26 and 29 mm in
`diameter. Your specialized Heart Team will determine which size is right for you.
`
`Edwards’ first transcatheter heart valve was approved commercially in Europe in 2007
`and in the United States in 2011. To date, Edwards’ transcatheter heart valves have
`treated more than 150,000 patients in over 65 countries around the world.
`
`An illustration of the SAPIEN 3 valve
`is pictured to the right.
`
`Image is larger than actual valve size.
`
`Metal Frame
`
`Three Tissue Leaflets
`(made from cow
`heart tissue)
`
`Fabric Skirt
`
`7
`
`8
`
`Page 5 of 11
`
`

`

`T R A N S F E M O R A L ( T F ) A P P R O A C H
`
`What Do You Need to Do
`Before the Procedure?
`Be sure to talk with your
`specialized Heart Team about any
`medication you may be taking.
`They might advise you to stop
`taking certain medication up to
`one week prior to the procedure.
`Your doctor may tell you not to eat
`or drink anything after midnight.
`You should plan on making
`arrangements for a ride to and
`from the hospital, and arrange for
`help at home after the procedure.
`
`The total procedure time varies
`from about 1 to 2 hours.
`
`TAVR allows a new valve to be inserted
`through a catheter.
`
`1. Before your procedure, you may be
`placed under anesthesia.
`
`2. A small incision will be made in your
`leg where your doctor will insert a
`short, hollow tube called a sheath.
`
`Catheter
`
`Balloon
`
`SAPIEN 3 valve
`compressed
`on balloon
`
`Diseased
`valve
`
`Expanded
`SAPIEN 3
`valve
`
`SAPIEN 3
`valve in place
`within the
`diseased
`valve
`
`3. Your new valve will be placed on
`the delivery system tube and
`compressed on the balloon to
`make it small enough to fit
`through the sheath.
`
`4. The balloon of the delivery system
`carrying the valve will be inflated,
`expanding this new valve within
`your diseased valve. The new valve
`will push the leaflets of your
`diseased valve aside. The frame of
`the new valve is strong and it will use
`the leaflets of your diseased valve to
`secure it in place. The balloon will
`then be deflated and removed.
`
`10
`
`5. Your doctor will make sure that your
`new valve is working properly before
`removing the sheath and closing the
`incision in your leg.
`
`9
`
`Page 6 of 11
`
`

`

`What Happens After the Procedure?
`Your specialized Heart Team will discuss your after-care plan with you. They will give
`you specific instructions to help you with your recovery. This may include a special
`diet, exercise and medicine. It is important to carefully follow your doctor’s
`directions, especially if blood-thinning medication is prescribed.
`
`Regular check-ups with your doctor are very important. Call or see your doctor
`whenever you have questions or concerns about your health. If you have any
`unusual problems such as bleeding, pain, other discomfort or changes in your
`overall health, be sure to contact your doctor.
`
`Always tell other doctors about your heart valve replacement before any medical,
`dental or MRI (magnetic resonance imaging) procedures. Failure to do so may
`result in damage to the valve that could lead to death.
`
`Average Length of
`Hospital Stay
`
`5 DAYS
`
`Make sure you speak to your
`specialized Heart Team regarding
`length of stay and how quickly you
`can expect to transition to home care.
`
`What Are the Benefits of TAVR?
`Benefits of the Procedure: If you have severe aortic stenosis,
`TAVR will help your heart to work better. It may also shorten
`your recovery time to getting back to everyday activities.
`
`Quality of Life Improvement:
`Quality of life studies with the SAPIEN 3 valve have shown
`patient health improvements within 30 days including: the
`ability to take care of themselves and to participate in
`everyday activities.
`
`How Long Will My Valve Last?
`How long your tissue valve will last depends on many
`patient factors and medical conditions. The long-term
`durability of the SAPIEN 3 valve has not been established.
`However, regular follow-ups will help your doctor know how
`your valve is working.
`
`11
`
`12
`
`Page 7 of 11
`
`

`

`I N T E R M E D I A T E - R I S K
`
`TAVR AND SURGERY
`CLINICAL DATA FOR
`INTERMEDIATE-RISK
`PATIENTS
`The risks associated with surgery
`depend on how healthy or sick a
`patient is. Based on their health, some
`patients may be considered
`intermediate-risk for surgery. If you are
`at intermediate-risk for surgery, these
`clinical data may resemble what you
`can expect.
`
`As part of the PARTNER II Trial, the
`SAPIEN 3 valve was studied in patients
`at intermediate-risk for surgery. The
`trial enrolled about 1,000 patients in
`the United States. Patients were
`examined at 30 days and 1 year after
`the procedure and will continue to be
`followed every year for 10 years.
`
`The outcomes in this trial were
`compared to those of patients
`who participated in another trial
`and were treated with surgery.
`The following tables show results
`of these two groups of patients.
`Patients who received the SAPIEN 3
`valve had clinically lower observed
`rates of death and stroke.
`
`Clinical data for intermediate-risk patients with TAVR
`The following table summarizes the 30-day and 1-year results of patients
`at intermediate-risk who were treated with TAVR with the SAPIEN 3 valve.
`
`Clinical data for intermediate-risk patients with surgery
`The following table summarizes the 30-day and 1-year results of patients
`at intermediate-risk who were treated with surgery.
`
`TAVR - Intermediate-Risk Clinical Outcomes
`
`Surgery - Intermediate-Risk Clinical Outcomes
`
`Risk Within 30 Days
`
`Risk Within 1 Year
`
`Risk Within 30 Days
`
`Risk Within 1 Year
`
`Death From Any Cause
`
`1 out of 100 patients
`
`7 out of 100 patients
`
`Death
`
`4 out of 100 patients
`
`13 out of 100 patients
`
`Cardiovascular Death*
`
`1 out of 100 patients
`
`4 out of 100 patients
`
`Cardiovascular Death*
`
`3 out of 100 patients
`
`8 out of 100 patients
`
`Major Stroke
`
`1 out of 100 patients
`
`2 out of 100 patients
`
`Major Stroke
`
`4 out of 100 patients
`
`6 out of 100 patients
`
`Aortic Insufficiency > Moderate†
`
`4 out of 100 patients
`
`2 out of 100 patients
`
`Aortic Insufficiency > Moderate†
`
`1 out of 100 patients
`
`1 out of 100 patients
`
`New Pacemaker
`Implantation‡
`
`11 out of 100 patients
`
`Major Vascular Complications
`
`6 out of 100 patients
`
`Myocardial Infarction
`(heart attack)
`
`1 out of 100 patients
`
`N/A
`
`N/A
`
`N/A
`
`New Pacemaker
`Implantation‡
`
`7 out of 100 patients
`
`Major Vascular Complications
`
`5 out of 100 patients
`
`Myocardial Infarction
`(heart attack)
`
`2 out of 100 patients
`
`N/A
`
`N/A
`
`N/A
`
`Endocarditis§
`
`1 out of 100 patients
`
`1 out of 100 patients
`
`Endocarditis§
`
`0 out of 100 patients
`
`1 out of 100 patients
`
`The frequency is shown as the number of patients out of every 100.
`
`The frequency is shown as the number of patients out of every 100.
`
`13
`
`* From heart-related causes
`† When the aortic valve does not close tightly and causes a backward flow of blood
`‡ Device that can help regulate the heart
`§ Inflammation or infection of any internal heart structures, including the valves
`
`14
`
`Page 8 of 11
`
`

`

`H I G H - R I S K A N D I N O P E R A B L E
`
`TAVR CLINICAL DATA FOR
`HIGH-RISK AND INOPERABLE
`PATIENTS
`The risks associated with surgery
`depend on how healthy or sick a
`patient is. Based on their health, some
`patients may be considered high-risk or
`too sick for surgery. If you are at high-
`risk or too sick for surgery, these clinical
`data reflect what you can expect.
`
`The PARTNER II Trial studied the
`SAPIEN 3 valve in patients who are
`at high-risk or too sick for surgery.
`The trial was conducted in the United
`States in approximately 600 patients.
`They were examined at 30 days and
`1 year and will continue to be
`examined every year for 10 years.
`
`Clinical data for high-risk and inoperable patients with TAVR
`The following table summarizes the 30-day and 1-year results of patients at high-risk
`or too sick for surgery who were treated with TAVR with the SAPIEN 3 valve.
`
`TAVR - High-Risk and Inoperable Clinical Outcomes
`
`Risk Within 30 Days
`
`Risk Within 1 Year
`
`Death From Any Cause
`
`2 out of 100 patients
`
`13 out of 100 patients
`
`Cardiovascular Death*
`
`1 out of 100 patients
`
`8 out of 100 patients
`
`Major Stroke
`
`2 out of 100 patients
`
`2 out of 100 patients
`
`Aortic Insufficiency > Moderate†
`
`3 out of 100 patients
`
`3 out of 100 patients
`
`New Pacemaker
`Implantation‡
`
`14 out of 100 patients
`
`17 out of 100 patients
`
`Major Vascular Complications
`
`6 out of 100 patients
`
`N/A
`
`Myocardial Infarction
`(heart attack)
`
`1 out of 100 patients
`
`2 out of 100 patients
`
`Endocarditis§
`
`1 out of 100 patients
`
`2 out of 100 patients
`
`The frequency is shown as the number of patients out of every 100.
`
`* From heart-related causes
`† When the aortic valve does not close tightly and causes a backward flow of blood
`‡ Device that can help regulate the heart
`§ Inflammation or infection of any internal heart structures, including the valves
`
`15
`
`• Pain, inflammation and fever
`• Pain or changes at the incision site
`• Problems with the valve or
`accessories that do not allow it to
`work well, including but not limited
`to: wear, tear or movement forward
`(prolapse) or backward (retraction)
`from the normal position of the valve
`leaflets, calcium build up on the
`leaflets, or a break in the frame
`
`• Incorrect position of valve or valve
`movement
`
`• Blood leak around the valve
`
`• Additional cardiac surgery,
`vascular surgery or intervention
`
`WHAT ARE THE RISKS OF TAVR?
`As with any medical procedure, there
`is a possibility of complications.
`
`The most serious risks of the TAVR
`procedure with the SAPIEN 3 valve
`include:
`
`• Death
`
`• Major stroke; a condition when
`blood stops flowing in the brain,
`which may cause severe disability
`
`• Major vascular complications; a large
`blood clot under the skin, which will
`require another surgery
`
`• Life threatening bleeding event;
`a bleeding event that requires a
`blood transfusion
`
`Additional potential risks associated
`with the procedure include:
`
`• Heart attack
`• Failure of your heart to pump enough
`blood to the body organs
`• Irregular heart rate
`
`• Problems with the electrical pathway
`of your heart that requires a pacemaker
`• Collection of fluid or blood around
`your heart
`• Having an abnormal particle (air,
`blood clots) floating in the blood
`stream or attached to an object,
`including the valve
`• Infection to your heart, blood or
`other areas
`• Injury to your blood vessels or heart
`that require treatment
`• Blocking, narrowing or bulging of
` a blood vessel
`• Blood clot, including a blood clot
`on the valve
`
`• Trouble or inability to breathe
`• Fluid build-up in your lungs
`• Anemia
`• Lab values that are not normal
`• Abnormally high or low blood
`pressure
`
`16
`
`Page 9 of 11
`
`

`

`PRECAUTIONS
`• TAVR patients should stay on blood-thinning medication for 6 months after the
`procedure and aspirin for the rest of their lives, or as their doctor recommends.
`Patients who do not take blood-thinning medication may be at increased risk of
`developing a dangerous blood clot. This may result in a stroke. Blood-thinning
`medicine may increase the risk of bleeding in the brain (stroke).
`• TAVR patients who are going to have dental procedures should receive
`antibiotics to help decrease the chance of getting an infection.
`• The safety of the SAPIEN 3 valve is not known for patients who have:
`
`- An existing artificial aortic heart valve
`
`- A heart that does not pump efficiently
`
`- An enlarged heart
`
`WHO SHOULD NOT HAVE
`THE PROCEDURE?
`The SAPIEN 3 valve and delivery systems
`should not be used in patients who:
`• Cannot tolerate medications that
`thin the blood or prevent blood clots
`from forming
`• Have an active infection in
`the heart or elsewhere
`
`• The safety and performance of
`the SAPIEN 3 valve has not been
`established for patients who have:
`
`- An aortic heart valve that is not
`calcified
`
`diseased or too small for the
`delivery device
`
`- Aortic valve leaflets with large pieces
`of calcium that may block the vessels
`that supply blood to the heart
`
`- An aortic heart valve that only has
`one or two leaflets
`
`- A diseased aortic valve in which the
`main problem is valve leakage
`
`- A previously implanted medical
`device in any heart valve
`
`- A diseased mitral valve that is
`calcified or leaking
`
`- Low white blood cell count, low red
`blood cell count, or other
`abnormalities in the blood
`
`- Unusual ultrasound images of the
`heart that could represent
`abnormalities such as a blood clot
`
`- Allergies to blood-thinning
`medications or dye that is injected
`during the procedure
`
`- An aortic valve that is too small or
`too big to fit the transcatheter
`heart valve
`
`- Diseased or abnormally shaped
`vessels leading to the heart
`
`- Femoral vessels that are heavily
`
`WARNINGS
`• Stroke may happen in patients who
`get TAVR procedures. This happens less
`if aortic stenosis is treated with
`medicine and by inflating a balloon
`inside the heart.
`• Major blood vessel complications may
`occur in TAVR procedures. This occurs
`less if aortic stenosis is instead treated
`with medicine and by inflating a
`balloon inside the heart
`• The valve implant may not last as
`long in patients who do not process
`calcium normally
`• Talk to your doctor if you are allergic
`to the implant materials. These
`include anesthesia, contrast media,
`chromium, nickel, molybdenum,
`manganese, copper, silicon,
`and plastics
`• X-ray may cause radiation injury to
`the skin
`
`17
`
`18
`
`Page 10 of 11
`
`

`

`CONTACT INFORMATION
`
`For more information on the
`SAPIEN 3 valve or the TAVR
`procedure:
`
`Toll free phone in the USA:
`1.800.424.3278
`
`Phone from outside the USA:
`+1.949.250.2500
`
`Email Address:
`Tech_Support@edwards.com
`
`Mail:
`Edwards Lifesciences
`One Edwards Way
`Irvine, California 92614
`
`Online:
`www.NewHeartValve.com
`www.TAVRbyEdwards.com
`www.Edwards.com
`
`Data on file at Edwards Lifesciences.
`CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information,
`including indications, contraindications, warnings, precautions and adverse events.
`
`Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation.
`
`© 2016 Edwards Lifesciences Corporation. All rights reserved. DOC-0041194B
`Edwards Lifesciences • One Edwards Way, Irvine CA 92614 USA • edwards.com
`
`Page 11 of 11
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