`
`FDA approves expanded indication for two
`transcatheter heart valves for patients at
`intermediate risk for death or
`complications associated with openheart
`surgery
`
`For Immediate Release
`
`August 18, 2016
`
`Release
`
`The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3
`transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or
`complications associated with openheart surgery. These devices were previously approved only in patients at high or
`greater risk for death or complications during surgery.
`
`“This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk
`patients,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for
`Devices and Radiological Health. “This new approval significantly expands the number of patients indicated for this
`less invasive procedure for aortic valve replacement.”
`
`Aortic valve stenosis increases with age as the aortic valve becomes narrow, causing the heart to work harder to
`pump enough blood through a smaller opening. It occurs in about three percent of Americans over age 75 and can
`cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with
`severe aortic valve stenosis generally need to have a heart valve replacement to improve blood flow through their
`aortic valve.
`
`Traditionally, openheart surgery has been the gold standard for aortic valve replacement in intermediate risk patients,
`but it involves a larger incision and longer recovery time than the minimally invasive procedure used to insert the
`transcatheter heart valve. About onethird of patients referred for openheart surgery for aortic valve replacement fall
`into the “intermediate risk” category, which is defined as having a greater than three percent risk of dying within 30
`days following surgery.
`
`In a clinical study to evaluate safety and effectiveness, 1,011 aortic stenosis patients at intermediate risk for surgical
`complications were randomly selected to have a transcatheter aortic valve replacement procedure using the Sapien
`XT valve and 1,021 were randomly selected to have a traditional aortic valve replacement during openheart surgery
`
`1/3
`
`Page 1 of 3
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2002
`
`
`
`11/14/2016 Press Announcements > FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complication…
`
`using a surgical tissue valve. In a second study, 1,078 intermediate risk patients were implanted with the Sapien 3
`valve; and outcomes in these patients were compared to the same group of 1,021 surgical control patients in the first
`study. The two studies demonstrated a reasonable assurance of safety and effectiveness of the Sapien XT and
`Sapien 3 devices in intermediate risk patients.
`
`Patients who receive either the Sapien XT or the Sapien 3 valve face a potential risk of serious complications from the
`device or implantation procedure, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a
`permanent pacemaker.
`
`The devices are contraindicated for patients who cannot tolerate blood thinning medication. They are also
`contraindicated for those who are currently being treated for a bacterial or other infection.
`
`As part of the approval of these devices, the FDA is requiring the manufacturer to conduct a postapproval study to
`follow the patients treated with either device in the first and second clinical studies for 10 years to further monitor
`safety and effectiveness.
`
`Sapien XT and Sapien 3 are manufactured by Edwards Lifesciences, LLC, based in Irvine, California.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by
`assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products
`for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food
`supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco
`products.
`
`###
`
`Inquiries
`
`Media
`
` Deborah Kotz (mailto:deborah.kotz@fda.hhs.gov)
` 3017965349
`
` Tara Goodin (mailto:tara.goodin@fda.hhs.gov@fda.hhs.gov)
` 2404023157
`
`Consumers
`
` 888INFOFDA
`
`Related Information
`
`FDA: Medical Devices (/MedicalDevices/default.htm)
`National Heart Lung and Blood Institute: What is heart valve disease? (https://www.nhlbi.nih.gov/health/health
`topics/topics/hvd/)
`Edwards SAPIEN XT Transcatheter Heart Valve P130009/S057
`(/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently
`
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517281.htm
`
`2/3
`
`Page 2 of 3
`
`
`
`11/14/2016 Press Announcements > FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complication…
`
`ApprovedDevices/ucm517194.htm)
`Edwards SAPIEN 3 Transcatheter Heart Valve P140031/S010
`(/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently
`ApprovedDevices/ucm517195.htm)
`
`Follow FDA
`
`Follow @US_FDA (https://twitter.com/US_FDA)
`(/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`Follow FDA (https://www.facebook.com/FDA)
`(/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`Follow @FDAmedia (https://twitter.com/FDAMedia)
`(/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`
`
`
`More in Press Announcements
`(/NewsEvents/Newsroom/PressAnnouncements/default.htm)
`
`2015 (/NewsEvents/Newsroom/PressAnnouncements/2015/default.htm)
`
`2014 (/NewsEvents/Newsroom/PressAnnouncements/2014/default.htm)
`
`2013 (/NewsEvents/Newsroom/PressAnnouncements/2013/default.htm)
`
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517281.htm
`
`3/3
`
`Page 3 of 3
`
`