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Si, sono un operatore sanitario
Note: Ai sensi e per gli effetti dell’Art. 76 D.P.R. 445/2000 consapevole della responsabilità e delle conseguenze civili e penali previste in caso di dichiarazioni mendaci e/o formazione od uso di atti falsi, nonché in caso di esibizione atti contenenti dati non più corrispondenti a verità e consapevole altresì che qualora emerga la non veridicità del contenuto della presente decadranno i benefici per i quali la stessa è rilasciata confermo di essere un OPERATORE SANITARIO.
I contenuti presenti in questo sito contengono informazioni rivolte agli operatori sanitari, in quanto si riferiscono a prodotti rientranti nella categoria dei dispositivi medici che richiedono l’impiego o l’intervento da parte di professionisti del settore medico-sanitario.
The Evolut TAVI platform is backed by a robust body of clinical evidence. Studies below are organized by product name and link to a downloadable presentation or study PDF.
ADVANCE is a multicenter, prospective, single-arm, observational study to evaluate safety and performance of the CoreValve system in a routine hospital setting with results out to 5 years.
Patients underwent attempted implant under the same inclusion and exclusion criteria and trial procedures as the Pivotal trial.
The purpose of this study was to evaluate the safety and effectiveness of the CoreValve system in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional comorbidities.
The Extreme Risk CoreValve Pivotal Trial evaluated the safety and efficacy of the Medtronic CoreValve system for the treatment of patients with symptomatic severe aortic stenosis in whom the predicted risk of operative mortality or serious, irreversible morbidity was 50% or greater at 30 days.
The High Risk CoreValve Pivotal Trial is a prospective, randomized, multicenter, noninferiority trial to compare the safety and efficacy of the Medtronic CoreValve system to SAVR in patients with symptomatic severe aortic stenosis at increased surgical risk.
The Nordic Aortic Valve Intervention (NOTION) Trial randomized all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), including a lower-risk patient population from 3 centers in Denmark and Sweden.
The SURTAVI Trial is a prospective, randomized, multicenter, noninferiority study to compare the safety and efficacy of the Medtronic TAVR system* to SAVR in patients with symptomatic severe aortic stenosis at intermediate surgical risk.
The Evolut R CE Mark Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients with symptomatic aortic stenosis and heart-team assessed risk of operative mortality.
The FORWARD Study is a prospective, single-arm, multicenter, observational study to assess the safety and clinical performance of the Medtronic Evolut R system in patients with symptomatic native aortic stenosis or failed bioprosthesis in routine practice.
The Evolut R US Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients deemed high or greater risk for surgery. As an appendix study, 60 patients were studied with the 34 mm valve.
The Evolut R U.S. Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients deemed high or greater risk for surgery.
VIVA is a prospective, observational, single-arm, post-market, multicenter study to collect data regarding use of TAVI with the CoreValve and Evolut R devices in patients with failing surgical aortic bioprostheses at high risk for re-do open-heart surgery.
Patients underwent attempted TAV implant under the same inclusion and exclusion criteria and trial procedures as the SURTAVI Trial, with no randomization to surgery.†
The Evolut PRO Study is a prospective, multicenter, controlled, non-randomized single-arm study. Primary safety endpoints were all cause mortality and disabling stroke at 30 days, and the primary efficacy endpoint was percentage of patients with no or trace aortic regurgitation at 30 days.
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84% of patients received CoreValve and 16% received Evolut R.
93% of patients received Evolut R and 7% received CoreValve.
Medtronic Italia S.p.A. Società a socio unico soggetta ad attività di direzione e coordinamento da parte di Medtronic PLC.
Cap. soc. € 1.200.487,00 - Codice fiscale, partita IVA e numero di iscrizione al Registro delle Imprese di Milano-Monza-Brianza-Lodi 09238800156 – REA MI – 1275682. Sede Legale e Uffici Via Varesina, 162 Edificio Raimondi - 20156 Milano.