Home » EuroPCR: Medtronic Evolut™ TAVR Platform Demonstrates Improved Quality of Life…

EuroPCR: Medtronic Evolut™ TAVR Platform Demonstrates Improved Quality of Life…

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EuroPCR: Medtronic Evolut™ TAVR Platform Demonstrates Improved Quality of Life…

20.05.2024 – 14:34


Atlanta and Dublin (ots/PRNewswire)

Medtronic is releasing new knowledge from the brand new SMART research designed completely for ladies

Medtronic, a worldwide chief in healthcare expertise, in the present day introduced new knowledge from the most important transfemoral transcatheter aortic valve alternative (TAVR) research, the Small Annuli Randomized To Evolut or SAPIEN (SMART) research, carried out completely in girls . The outcomes confirmed that the Evolut self-expanding valve (SEV) was related to bioprosthetic valve dysfunction (BVD) and improved high quality of life in girls with symptomatic extreme aortic stenosis (AS). The knowledge was offered as a baseline research on the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2024.

AS with extreme signs could be deadly if untreated, and the common life expectancy of sufferers is 2 years with out remedy.1 Despite the longer life expectancy of girls, after they endure from extreme AS, they die greater than males, even when one yr is taken into account.2 Both TAVR and surgical aortic valve alternative (SAVR) are choices for ladies to deal with AS. However, due to their smaller aortic annulus, girls typically obtain valve replacements that don’t match their anatomy nicely.3

The outcomes confirmed that the first scientific consequence (dying, disabling stroke, or coronary heart failure readmission) in girls with AS and a small annulus at one yr was just like that in girls who acquired balloon expandable valve (BEV) or SEV. However, in comparison with the expandable balloon valve, the Evolut SEV was related to considerably much less BVD (8.4% vs 41.8% at 12 months), with much less patient-to-patient variations (11.1% vs 37.4% at 12 months) , small or massive aortic. restoration (12.3% versus 18.8% at 12 months) and higher high quality of life in girls with AS and a small annulus.

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“This research is a vital milestone for ladies who’ve traditionally been excluded and underrepresented in scientific trials,” stated Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, MSCAI, Professor of Medicine and Director of Interventional Cardiovascular Research and Clinic. trials at Mount Sinai School of Medicine and co-leader of the SMART research. “This knowledge set highlights that the Evolut TAVR system was related to much less dysfunction of bioprosthetic valves and an improved high quality of life in girls in comparison with expandable balloon valves.”

The SMART trial is the most important TAVR trial so far, enrolling primarily girls (87%). It was designed to higher perceive how the 2 mostly used TAVR methods work in sufferers with aortic appendages (SAA), who’re sometimes girls. SMART is a world, potential, multicenter, randomized (1:1), postmarketing research evaluating the protection and efficacy of SEV and BEV TAVR in sufferers with extreme symptomatic AS and SAA. The research randomized and handled 637 girls at greater than 80 websites world wide. Patients with a computed tomography aortic valve annulus space of ​​≤430 mm2 and appropriate anatomy for transfemoral TAVR with the Evolut PRO/PRO+/FX or SAPIEN 3™/3 Ultra™ valve had been eligible.

“The knowledge offered in the present day at EuroPCR present robust perception into the advantages of Evolut TAVR for ladies,” stated Matt Leafstedt, vice chairman of Structural Heart in Western Europe, a part of Medtronic’s cardiovascular portfolio. “This new evaluation highlights the effectiveness of TAVR as an answer to realize superior valve perform, whereas highlighting the significance of scientific proof to find out the very best remedy choices for ladies.”

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Information about Medtronic

Thinking boldly. Brave actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the world‘s main well being expertise firm, boldly tackling difficult human well being issues by looking for and discovering options. Our mission – to alleviate ache, restore well being and lengthen life – unites a worldwide staff of greater than 95,000 devoted individuals in 150 nations. Our applied sciences and therapies deal with 70 illnesses and embrace cardiac units, surgical robots, insulin pumps, surgical devices, affected person monitoring methods and extra. Driven by our intensive data, our insatiable curiosity and our want to assist these in want, we ship new applied sciences that change the lives of two individuals each second, each hour, every single day. Expect extra from us as we empower insight-driven care, people-centered experiences, and higher outcomes for our world. We try to go above and past in all the pieces we do. For extra details about Medtronic (NYSE:MDT), go to www.Medtronic.comand observe Medtronic at LinkedIn.

All forward-looking statements are topic to dangers and uncertainties as described in Medtronic’s periodic stories filed with the Securities and Exchange Commission. Actual outcomes could differ materially from anticipated outcomes.

SAPIEN, SAPIEN 3 and SAPIEN 3 Ultra are logos of Edwards Lifesciences Corporation.

1 Carabello BA, Paulus WJ. Aortic stenosis. The Lancet. March 14, 2009;373(9667):956-966.

2 Tribouilloy C, Bohbot Y, Russian D, et al. J Am Heart Assoc. 2021;10:e018816. DOI: 10.1161/JAHA.120.018816.

3 Lester SJ, Heilbron B, Gin Okay, Dodek A, Jue J. Natural historical past and price of development of aortic stenosis. Chest. Apr 1998;113(4):1109-1114

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Press the contact:

Marica Orlandi,
Public relations,
+39 346 1124979 / Ryan Weispfenning,
investor relations,

Original content material from: Medtronic, relayed by information aktuell

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