{"article":{"annotation":{"article_id":"fda-approves-adjustable-pediatric-heart-valve","available_at":"2026-10-07T03:14:14.787754Z","geography_revision":"ef6ee0010dda5fe7b240fd514749b43e214c57da73222d2e40ec83b276dd0977","id":"ad69bd7b67d958f7344874cb7693295f8ac9fcb2b85914140c861e256f0be3d3","input_sha256":"d2e212f64edcbdd60343239bc62ddf102673b20e64aae6b3c1c912b5e5158bf3","limitations":["Rule-derived subjects are candidates, not verified editorial labels or calibrated model probabilities.","Coverage is distinct from event location. Unknown country/city/coordinates remain absent; no automatic geocoding.","Article geometries keep their stated precision and methodology; reproducing them is not independent coordinate verification."],"method":"controlled-rules-v1","places":[{"admin1":null,"city":null,"coordinate_note":null,"coordinate_reference_system":"OGC:CRS84","coordinate_source":null,"country":"US","evidence":[{"field":"country","language":"en","note":"Explicit preserved editorial country/region; no city or national centroid inferred","source_urls":["https://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children"]}],"geometry":null,"id":"iso3166-1:US","kind":"country-or-area","labels":{"ar":"الولايات المتحدة الأمريكية","en":"United States of America","es":"Estados Unidos de América","fr":"États-Unis d’Amérique"},"match_status":"candidate","precision":"regional","role":"coverage","uncertainty_m":null}],"rules_sha256":"d28c9c89703b56bd91fd887965d416d0115c2473d4bfbd3e558bcceafc3941dd","schema_version":1,"subjects":[{"concept_id":"medtop:07000000","confidence":null,"confidence_method":null,"evidence":[{"field":"category+topics","language":"en","note":"Preserved editorial category/topic; broad candidate only","source_urls":["https://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children"]}],"method":"controlled-rules-v1","rule_id":"health-broad","status":"candidate"}],"taxonomy_revision":"1f2db31d811fca07e99b16d402c10e2cc2965c9df1c7b41d9be348b40a24e7fb","taxonomy_version":"IPTC Media Topics 2026-Q2"},"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=en","category":"health","content":{"key_points":[],"paragraphs":["The FDA approved the Autus Size-Adjustable Valve for pediatric patients with congenital pulmonary valve disease. A clinician can widen the implanted valve with a balloon catheter as a child grows: its initial diameter can be about 13 millimeters and its expanded size can reach 22 millimeters. The valve does not grow on its own and uses polymer leaflets rather than animal-derived tissue.","The supporting study enrolled 62 children at 12 U.S. sites, but the six-month blood-flow endpoint reported by FDA covered the first 60. Three patients had valve-frame fractures and two had reduced leaflet movement; FDA said these events caused no symptoms. Two patients whose valve performance began to decline as they outgrew the device had it expanded without surgery, though the agency said experience remains limited and longer-term studies continue."],"sections":[]},"corrections":[{"at":"2026-10-07T00:50:06+03:00","language":"en","text":"German and Portuguese editions and translations of the data and correction explanations have been added to this article."},{"at":"2026-10-07T05:57:41+03:00","language":"en","text":"Data classification added: each figure now carries a measure identifier with its unit, geography, frequency and type. No figure, unit or date changed."}],"country":"US","data":{"blocks":[{"description":{"ar":"أرقام الدراسة والجهاز الواردة في موافقة الإدارة.","de":"Studien- und Geräteangaben aus der FDA-Zulassung.","en":"Study and device figures cited in the FDA approval.","es":"Datos del estudio y del dispositivo citados en la aprobación de la FDA.","fr":"Données de l’étude et du dispositif citées dans l’autorisation de la FDA.","pt":"Dados do estudo e do dispositivo citados na aprovação da FDA.","tr":"FDA onayında belirtilen çalışma ve cihaz ölçüleri."},"id":"autus-valve-study","items":[{"basis":"observed","label":{"ar":"الأطفال المشاركون","de":"Aufgenommene Kinder","en":"Children enrolled","es":"Niños inscritos","fr":"Enfants inclus","pt":"Crianças inscritas","tr":"Çalışmaya katılan çocuk"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-study-children-enrolled","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10-01","unit":"patients","value":62},{"basis":"observed","label":{"ar":"المرضى ضمن نتائج الأشهر الستة","de":"Patienten in den Sechsmonatsergebnissen","en":"Patients in six-month results","es":"Pacientes en los resultados a seis meses","fr":"Patients dans les résultats à six mois","pt":"Pacientes nos resultados de seis meses","tr":"Altı aylık sonuç kapsamındaki hasta"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-study-six-month-patients","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10-01","unit":"patients","value":60},{"basis":"observed","label":{"ar":"مواقع الدراسة الأمريكية","de":"Studienstandorte in den USA","en":"U.S. study sites","es":"Centros de estudio en EE. UU.","fr":"Sites d’étude aux États-Unis","pt":"Centros de estudo nos EUA","tr":"ABD çalışma merkezi"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-study-sites","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10-01","unit":"sites","value":12},{"basis":"observed","label":{"ar":"القطر الأولي التقريبي","de":"Ungefährer Anfangsdurchmesser","en":"Approximate initial diameter","es":"Diámetro inicial aproximado","fr":"Diamètre initial approximatif","pt":"Diâmetro inicial aproximado","tr":"İlk implant çapı yaklaşık"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-initial-diameter","periodRole":"announcement-date","unitCode":"millimetre"},"period":"2026-10-01","unit":"mm","value":13,"valueQualifier":"approximate"},{"basis":"observed","label":{"ar":"أقصى قطر بعد التوسيع","de":"Maximaler Durchmesser nach Erweiterung","en":"Maximum diameter after expansion","es":"Diámetro máximo tras la expansión","fr":"Diamètre maximal après expansion","pt":"Diâmetro máximo após expansão","tr":"Genişletme sonrası üst çap"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-maximum-diameter","periodRole":"announcement-date","unitCode":"millimetre"},"period":"2026-10-01","unit":"mm","value":22,"valueQualifier":"upper-bound"},{"basis":"observed","label":{"ar":"مرضى حدث لديهم كسر في الإطار","de":"Patienten mit Rahmenbruch","en":"Patients with frame fracture","es":"Pacientes con fractura del armazón","fr":"Patients avec fracture de l’armature","pt":"Pacientes com fratura da estrutura","tr":"Çerçeve kırığı görülen hasta"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-study-frame-fractures","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10-01","unit":"patients","value":3},{"basis":"observed","label":{"ar":"مرضى انخفضت لديهم حركة الشرفات","de":"Patienten mit eingeschränkter Segelbewegung","en":"Patients with reduced leaflet movement","es":"Pacientes con menor movimiento de valvas","fr":"Patients avec mobilité réduite des feuillets","pt":"Pacientes com movimento reduzido dos folhetos","tr":"Kapakçık hareketi azalan hasta"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-study-reduced-leaflet-movement","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10-01","unit":"patients","value":2},{"basis":"observed","label":{"ar":"صمامات وُسّعت دون جراحة","de":"Ohne Operation erweiterte Klappen","en":"Valves expanded without surgery","es":"Válvulas ampliadas sin cirugía","fr":"Valves élargies sans chirurgie","pt":"Válvulas ampliadas sem cirurgia","tr":"Ameliyatsız genişletilen kapak"},"measure":{"aggregation":"stock","frequency":"irregular","geography":"united-states","id":"autus-valve-study-expansions-without-surgery","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10-01","unit":"valves","value":2}],"methodology":{"ar":"شملت الدراسة 62 طفلاً في 12 موقعاً أمريكياً؛ وتتعلق نتيجة تدفق الدم بعد ستة أشهر بأول 60 مريضاً. حدث كسر في الإطار لدى ثلاثة مرضى وانخفضت حركة الشرفات لدى اثنين، دون أعراض ناتجة عن هذه الأحداث. ووُسّع صمامان دون جراحة، لكن الخبرة لا تزال محدودة.","de":"An der Studie nahmen 62 Kinder an 12 US-Standorten teil; das Sechsmonatsergebnis zum Blutfluss der FDA bezieht sich auf die ersten 60. Bei drei Patienten brach der Rahmen, bei zwei war die Bewegung der Klappensegel eingeschränkt, ohne dass diese Ereignisse Symptome verursachten. Zwei Klappen wurden ohne Operation erweitert; die Erfahrung ist weiterhin begrenzt.","en":"The study enrolled 62 children at 12 U.S. sites; FDA’s six-month blood-flow result concerns the first 60. Three patients had frame fractures and two had reduced leaflet movement, without symptoms from these events. Two valves were expanded without surgery; experience remains limited.","es":"El estudio incluyó a 62 niños en 12 centros de EE. UU.; el resultado de flujo sanguíneo a seis meses corresponde a los primeros 60. Tres pacientes tuvieron fracturas del armazón y dos menor movimiento de las valvas, sin síntomas derivados de esos eventos. Se ampliaron dos válvulas sin cirugía; la experiencia sigue siendo limitada.","fr":"L’étude a inclus 62 enfants dans 12 sites américains ; le résultat de circulation sanguine à six mois concerne les 60 premiers. Trois patients ont eu une fracture de l’armature et deux une mobilité réduite des feuillets, sans symptôme associé à ces événements. Deux valves ont été élargies sans chirurgie ; l’expérience reste limitée.","pt":"O estudo incluiu 62 crianças em 12 centros dos EUA; o resultado de fluxo sanguíneo em seis meses da FDA refere-se aos primeiros 60. Três pacientes tiveram fratura da estrutura e dois apresentaram movimento reduzido dos folhetos, sem sintomas associados a esses eventos. Duas válvulas foram ampliadas sem cirurgia; a experiência continua limitada.","tr":"Çalışma 62 çocuk ve 12 ABD merkezini kapsadı; FDA’nın altı aylık kan akışı sonucu ilk 60 hastaya ilişkindir. Üç hastada çerçeve kırığı, ikisinde kapakçık hareketinde azalma görüldü ve bu olaylar belirtiye yol açmadı. İki hastanın kapağı ameliyatsız genişletildi; deneyim sınırlıdır."},"sourceUrls":["https://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children"],"title":{"ar":"دراسة الصمام القابل للتعديل لدى الأطفال","de":"Studie zur verstellbaren Klappe bei Kindern","en":"Adjustable valve study in children","es":"Estudio de la válvula ajustable en niños","fr":"Étude de la valve ajustable chez les enfants","pt":"Estudo da válvula ajustável em crianças","tr":"Çocuklarda ayarlanabilir kapak çalışması"},"type":"metrics","updatedAt":"2026-10-07T00:50:06+03:00"}],"version":1},"data_downloads":[{"formats":{"csv":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve/data/autus-valve-study?lang=en&format=csv","json":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve/data/autus-valve-study?lang=en&format=json"},"id":"autus-valve-study"}],"data_types":["metrics"],"editorial_illustration":{"alt":"Conceptual illustration of public health, research and connected data.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"en","scope":"topic","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"event_id":"event-3746e9c4-6c7c-562e-8acb-1c4d72b906c1","event_period":"2026-10-01","event_period_basis":"event-or-reference-period","id":"fda-approves-adjustable-pediatric-heart-valve","image":null,"importance":0.6,"language":"en","modified_at":"2026-10-07T05:57:41+03:00","publication_basis":"publication-record","published_at":"2026-10-06T17:58:49+00:00","reading_minutes":1,"region":"world","section_illustration":{"alt":"Conceptual illustration of public health, research and connected data.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"en","scope":"section","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"slug":"fda-approves-adjustable-pediatric-heart-valve","sources":[{"checkedAt":"2026-10-06","name":"U.S. Food and Drug Administration","publishedAt":"2026-10-01","url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children"}],"summary":"The Autus valve is widened later with a balloon catheter; six-month study findings cover the first 60 of 62 enrolled patients.","text":"The Autus valve is widened later with a balloon catheter; six-month study findings cover the first 60 of 62 enrolled patients.\n\nThe FDA approved the Autus Size-Adjustable Valve for pediatric patients with congenital pulmonary valve disease. A clinician can widen the implanted valve with a balloon catheter as a child grows: its initial diameter can be about 13 millimeters and its expanded size can reach 22 millimeters. The valve does not grow on its own and uses polymer leaflets rather than animal-derived tissue.\n\nThe supporting study enrolled 62 children at 12 U.S. sites, but the six-month blood-flow endpoint reported by FDA covered the first 60. Three patients had valve-frame fractures and two had reduced leaflet movement; FDA said these events caused no symptoms. Two patients whose valve performance began to decline as they outgrew the device had it expanded without surgery, though the agency said experience remains limited and longer-term studies continue.\n\nGerman and Portuguese editions and translations of the data and correction explanations have been added to this article.\n\nData classification added: each figure now carries a measure identifier with its unit, geography, frequency and type. No figure, unit or date changed.","title":"FDA approves balloon-expandable pulmonary valve for children","topics":[],"translations":[{"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=tr","language":"tr","url":"https://newsverum.com/tr/news/fda-approves-adjustable-pediatric-heart-valve"},{"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=en","language":"en","url":"https://newsverum.com/en/news/fda-approves-adjustable-pediatric-heart-valve"},{"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=ar","language":"ar","url":"https://newsverum.com/ar/news/fda-approves-adjustable-pediatric-heart-valve"},{"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=fr","language":"fr","url":"https://newsverum.com/fr/news/fda-approves-adjustable-pediatric-heart-valve"},{"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=es","language":"es","url":"https://newsverum.com/es/news/fda-approves-adjustable-pediatric-heart-valve"},{"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=de","language":"de","url":"https://newsverum.com/de/news/fda-approves-adjustable-pediatric-heart-valve"},{"api_url":"https://newsverum.com/api/v1/articles/fda-approves-adjustable-pediatric-heart-valve?lang=pt","language":"pt","url":"https://newsverum.com/pt/news/fda-approves-adjustable-pediatric-heart-valve"}],"url":"https://newsverum.com/en/news/fda-approves-adjustable-pediatric-heart-valve"},"version":"1"}