throbber
4/4/2017
`
`TAVR by Edwards
`
`MENU
`
`(https://www.tavrbyedwards.com/)
`
`TAVR with the Edwards SAPIEN 3 valve
`
`Better Than Surgery
`
`for Intermediate-Risk Patients*
`*The PARTNER II trial intermediate-risk cohort, VI population (n=2,005); the di韚erence in the primary endpoint (composite of all-cause mortality, all stroke,
`and ≥ moderate aortic regurgitation at one year) event rate between TAVR with the SAPIEN 3 valve and surgery appeared to be clinically signiퟌcant.
`
`Ask your doctor about transcatheter aortic valve replacement (TAVR) with the
`SAPIEN 3 valve today.
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`O U R L A T E S T V A L V E
`
`MENU
`
`(https://www.tavrbyedwards.com/)
`
`OUTER SEALING SKIRT
`Virtually eliminates moderate to severe leakage
`around the valve*
`*PARTNER II trial high-risk TF SAPIEN 3 valve cohort 30-day results
`
`APPROVED FOR INTERMEDIATE-RISK PATIENTS
`The SAPIEN 3 valve builds upon research and development we have
`conducted over several decades.
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`1/11
`
`Page 01 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`conducted over several decades.
`
`As the leader in heart valve science and innovation, we have purposefully designed our transcatheter heart valves with the same proven materials and features as
`our leading surgical valves.
`To request a free information kit, click here (/requests).
`
`(https://edwardspatientconnect.com/Answers/TBE_Tout_LatestValve)
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`(https://www.tavrbyedwards.com/)
`
`MENU
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`2/11
`
`Page 02 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`MENU
`
`(https://www.tavrbyedwards.com/)
`T H E C L I N I C A L D I F F E R E N C E
`
` (assets/downloads/SAPIEN_3_Patient_Brochure.pdf)
`
`(assets/downloads/PARTNER_II_Trial_Clinical_Events_Summary.pdf)
`Transcatheter aortic valve replacement
`(TAVR) with the Edwards SAPIEN 3 valve
`demonstrated 75% lower rates of 30-
`day all-cause mortality and disabling
`stroke compared to surgery in
`intermediate-risk patients.
`†
`
`
`
`†The PARTNER II trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVR with the SAPIEN 3 valve, as treated population (n=1,077).
`‡The PARTNER II trial intermediate-risk cohort unadjusted clinical event rates, AT population.
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`3/11
`
`Page 03 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`Y O U R P R O C E D U R E
`
`MENU
`
`At this moment, thousands of our heart valves are
`(https://www.tavrbyedwards.com/)
`HELPING PEOPLE LIVE THEIR LIVES
`Around the world, TAVR has helped people su韚ering from severe aortic stenosis. If you are researching treatment
`options for severe aortic stenosis or will be having the TAVR procedure, we are here to help you.
`
`(/requests)
`
`(https://edwardspatientconnect.com/Answers/TBE_Tout_HelpingPeople)
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`(https://www.tavrbyedwards.com/)
`
`MENU
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`4/11
`
`Page 04 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`Beneퟌts of TAVR:
`
`Relief of symptoms, in some cases immediately
`Reduction in pain and anxiety
`Improved heart function
`May shorten recovery time to resume everyday activities
`
`Quality of Life Improvement:
`
`TAVR has shown improvement in a patient's health as early as 30 days after their procedure. Patients
`reported improvements in quality of life, including:
`Ability to take care of themselves
`Ability to participate in everyday activities
`The most serious RISKS of the TAVR procedure are:
`death, major stroke, major vascular
`complications, and life threatening bleeding
`event.*
`
`It is important to talk with your doctor about the exact procedure you will have, the product you will receive, and the
`literature on clinical studies using that product.
`
`*See the Edwards SAPIEN 3 valve patient brochure (assets/downloads/SAPIEN_3_Patient_Brochure.pdf) for more
`detailed information on these and other risks.
`
`(https://edwardspatientconnect.com/Answers/TBE_Tout_TAVR_Beneퟌts)
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`(https://www.tavrbyedwards.com/)
`
`MENU
`
`Transfemoral Approach
`
`The most common way to perform TAVR is through the transfemoral approach. An incision will be made in
`your leg, where your doctor will insert a short, hollow tube called a sheath.
`
`The Edwards SAPIEN 3 transcatheter heart valve will be placed on the delivery system and compressed on a
`balloon. The delivery system carrying the valve will be placed through the sheath and delivered to your aortic
`valve. The balloon of the delivery system will be in埌ated, expanding the new valve within your diseased valve.
`
`The valve will push the lea埌ets of your diseased valve aside, securing itself into place. The new valve should
`begin working immediately.
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`5/11
`
`Page 05 of 11
`
`

`

`4/4/2017
`
`begin working immediately.
`
`TAVR by Edwards
`
`TAVR is a less invasive procedure available
`for people who need their aortic valve
`replaced and are at intermediate or greater
`risk for open heart surgery.
`
`To ퟌnd out if TAVR is right for you, please talk with your doctor and locate a TAVR Center near you.
`
`(https://edwardspatientconnect.com/Answers/TBE_Tout_TF_Approach)
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`MENU
`This guide will help you ask the right questions during your next
`doctor's visit.
`(https://www.tavrbyedwards.com/)
`
`(assets/downloads/Doctor_Discussion_Guide.pdf)
`
`(https://edwardspatientconnect.com/Answers/TBE_Tout_YourGuide)
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`6/11
`
`Page 06 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`MENU
`These educational materials will help you learn more about
`severe aortic stenosis and TAVR.
`(https://www.tavrbyedwards.com/)
`
`(/requests)
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`7/11
`
`MENU
`
`Page 07 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`
`
`(https://www.tavrbyedwards.com/)
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`(https://www.tavrbyedwards.com/)
`
`MENU
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`8/11
`
`Page 08 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`(https://www.tavrbyedwards.com/)
`
`MENU
`
`MORE THAN
`
`150,000
`
`PATIENTS
`treated with Edwards SAPIEN
`transcatheter heart valves
`WORLDWIDE*
`
`*Includes all valves from the Edwards SAPIEN transcatheter
`heart valve platform.
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`9/11
`
`Page 09 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`(https://www.tavrbyedwards.com/)
`
`MENU
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`10/11
`
`Page 10 of 11
`
`

`

`4/4/2017
`
`TAVR by Edwards
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`(https://www.tavrbyedwards.com/)
`
`MENU
`
`IMPORTANT RISK INFORMATION FOR PATIENTS
`
`https://tavrbyedwards.com/our­latest­heart­valve­sapien­3
`
`11/11
`
`Page 11 of 11
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket