Edwards - SAPIEN 3 TF Overview Description Next-generation balloon-expandable transcatheter heart valve delivered through a 14 Fr expandable eSheath; features a paravalvular leak solution and improved distal flexing History Edwards first discussed publicly its work on this project during its analyst day on Dec. 10, 2009. Edwards said during its Dec. 10, 2009 analyst day that it is working on enhanced transcatheter heart valve designs below 18 Fr. In a clinicaltrials.gov posting for the CE Mark trial dated March 7, 2013, Edwards company’s indicated that Edwards SAPIEN 3 is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement. On Jan. 13, 2014, Edwards announced completion of enrollment of its U.S. clinical trial studying the SAPIEN 3 valve in the treatment of high-risk or inoperable patients. On Jan. 27, 2014, Edwards announced that it has received CE Mark approval of the SAPIEN 3 valve and has initiated its launch. During its Q4 2013 earnings call on Feb. 4, 2014, Edwards said that it has commenced “an launch of this device in Europe, with a number of successful implants already in aggressive” 2014. The company noted that upgrading customers to this new be as platform “should fast” there is no need for extensive training and clinicians are to get their hands on “very eager” this exciting new technology. The company added that these reasons, we believe “for SAPIEN 3 will quickly become the leading transcatheter valve in Europe.” Source: Edwards - SAPIEN 3 TA / Tao Overview Description Next-generation balloon-expandable transcatheter heart valve designed for both transapical and transaortic approaches; features the Certitude delivery system History In a clinicaltrials.gov posting for the CE Mark trial dated March 7, 2013, Edwards company’s indicated that Edwards SAPIEN 3 is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement.
Edwards - SAPIEN 3 TF Overview Description Next-generation balloon-expandable transcatheter heart valve delivered through a 14 Fr expandable eSheath; features a paravalvular leak solution and improved distal flexing History Edwards first discussed publicly its work on this project during its analyst day on Dec. 10, 2009. Edwards said during its Dec. 10, 2009 analyst day that it is working on enhanced transcatheter heart valve designs below 18 Fr. In a clinicaltrials.gov posting for the company’s CE Mark trial dated March 7, 2013, Edwards indicated that Edwards SAPIEN 3 is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement. On Jan. 13, 2014, Edwards announced completion of enrollment of its U.S. clinical trial studying the SAPIEN 3 valve in the treatment of high-risk or inoperable patients. On Jan. 27, 2014, Edwards announced that it has received CE Mark approval of the SAPIEN 3 valve and has initiated its launch. During its Q4 2013 earnings call on Feb. 4, 2014, Edwards said that it has commenced “an aggressive” launch of this device in Europe, with a number of successful implants already in 2014. The company noted that upgrading customers to this new platform “should be fast” as there is no need for extensive training and clinicians are “very eager” to get their hands on this exciting new technology. The company added that “for these reasons, we believe SAPIEN 3 will quickly become the leading transcatheter valve in Europe.” Source: Edwards - SAPIEN 3 TA / Tao Overview Description Next-generation balloon-expandable transcatheter heart valve designed for both transapical and transaortic approaches; features the Certitude delivery system History In a clinicaltrials.gov posting for the company’s CE Mark trial dated March 7, 2013, Edwards indicated that Edwards SAPIEN 3 is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement.
1361-TAVI-FinalProtocol-accessible.docx