{"id":9781,"date":"2026-03-24T17:47:42","date_gmt":"2026-03-24T14:47:42","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=9781"},"modified":"2026-03-24T17:47:42","modified_gmt":"2026-03-24T14:47:42","slug":"transcatheter-aortic-regurgitation-trilogy-valve-in-the-fda-pre-approval-stage","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/transcatheter-aortic-regurgitation-trilogy-valve-in-the-fda-pre-approval-stage\/","title":{"rendered":"Transcatheter Aortic Regurgitation \u2013 Trilogy Valve in the FDA – Pre-Approval Stage"},"content":{"rendered":"
Transcatheter Aortic Regurgitation \u2013 Trilogy Valve in the FDA – Pre-Approval Stage<\/div>\n
<\/div>\n
Source: Medical News Update \u2013 TCTMD (2026)<\/div>\n
<\/div>\n
Clinical Problem<\/div>\n
\u2022 Transcatheter valves (TAVR) were historically designed for aortic stenosis (AS)<\/span><\/div>\n
\u2022 These systems rely on annular and leaflet calcification for:<\/span><\/div>\n
\u2022 Anchoring<\/span><\/div>\n
\u2022 Stability<\/span><\/div>\n
\u2022 In aortic regurgitation (AR):<\/span><\/div>\n
\u2022 Often no calcification<\/span><\/div>\n
\u2022 \u2192 Traditional TAVR valves fail to anchor properly<\/span><\/div>\n
\u2022 \u2192 High risk of:<\/span><\/div>\n
\u2022 Valve migration<\/span><\/div>\n
\u2022 Paravalvular leak<\/span><\/div>\n
<\/div>\n
Why AR Was Challenging<\/div>\n
\u2022 Lack of calcified landing zone<\/span><\/div>\n
\u2022 Dilated annulus and root<\/span><\/div>\n
\u2022 Unpredictable fixation with standard devices<\/span><\/div>\n
\ud83d\udc49 \u2192 AR long considered unsuitable for transcatheter therapy<\/div>\n
<\/div>\n
The Trilogy Valve \u2013 Key Innovation<\/div>\n
\u2022 Specifically designed for native AR (not AS)<\/span><\/div>\n
\u2022 Uses Locator Technology:<\/span><\/div>\n
\u2022 Mechanically engages native leaflets<\/span><\/div>\n
\u2022 Provides active anchoring (not calcification-dependent)<\/span><\/div>\n
\u2022 Enables:<\/span><\/div>\n
\u2022 Precise positioning<\/span><\/div>\n
\u2022 Improved stability<\/span><\/div>\n
<\/div>\n
Clinical Milestone<\/div>\n
\u2022 \u2705 The system is CE-marked in Europe and has been granted FDA \u201cBreakthrough Device designation\u201d<\/span><\/div>\n
\u2022 Represents a paradigm shift:<\/span><\/div>\n
\u2022 From \u201cnot feasible\u201d \u2192 \u201ctreatable\u201d<\/span><\/div>\n
<\/div>\n
Clinical Implications<\/div>\n
\u2022 Expands TAVR indications to:<\/span><\/div>\n
\u2022 Patients with severe AR unsuitable for surgery<\/span><\/div>\n
\u00a0 \u00a0 \u2022\u00a0 \u00a0 \u00a0ALIGN-AR (published in The Lancet): Trilogy demonstrates feasible and effective TAVR for severe AR.<\/div>\n
ALIGN-AR (Lancet 2024; expanded 2025):<\/div>\n
\u2022 Procedural success: ~95\u201397%<\/span><\/div>\n
\u2022 30-day mortality: ~1.6%<\/span><\/div>\n
\u2022 1-year mortality: ~7\u20138%<\/span><\/div>\n
\u2022 Stroke: ~0.6%<\/span><\/div>\n
\u2022 Moderate\/severe PVL: very low (~1\u20132%)<\/span><\/div>\n
<\/div>\n
\ud83d\udc49 Conclusion: Safe, effective TAVR for severe AR in high-risk patients.<\/div>\n
<\/div>\n
Reference (The Lancet)<\/div>\n
<\/div>\n
<\/div>\n
https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736%2825%2902215-9\/fulltext<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"

Transcatheter Aortic Regurgitation \u2013 Trilogy Valve in the FDA – Pre-Approval Stage Source: Medical News Update \u2013 TCTMD (2026) Clinical Problem \u2022 Transcatheter valves (TAVR) were historically designed for aortic stenosis (AS) \u2022 These systems rely on annular and leaflet calcification for: \u2022 Anchoring \u2022 Stability \u2022 In aortic regurgitation (AR): \u2022 Often no calcification […]<\/p>\n","protected":false},"author":145,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9781","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/9781","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/users\/145"}],"replies":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/comments?post=9781"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/9781\/revisions"}],"predecessor-version":[{"id":9782,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/9781\/revisions\/9782"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=9781"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=9781"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=9781"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}