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Ovatio DR and Ovatio VR · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Ovatio DR and Ovatio VR | DEVICE | implantable cardioverter defibrillator |
Inclusion Criteria: * Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the "ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" (Zi...
Ovatio DR and Ovatio VR are implantable cardioverter defibrillators (ICDs) used to treat patients at risk of sudden cardiac death. They are intended for individuals aged 18 years and older. The devices are part of a post-approval study conducted in the United States to monitor their real-world performance.
Ovatio DR and Ovatio VR are developed by LivaNova PLC, a company traded on the stock exchange under the ticker LIVN. LivaNova is responsible for the manufacturing and clinical development of these implantable cardioverter defibrillators.
Ovatio DR and Ovatio VR are in Phase 3 clinical development. A Phase 3 post-approval study, identified as NCT00586378, has been completed. The devices are investigational and remain under clinical evaluation, though the study's completion status indicates the trial has finished.
Ovatio DR and Ovatio VR are associated with one clinical trial, NCT00586378, titled 'Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study.' This Phase 3 trial enrolled 85 participants in the United States and has been completed. The study was uncontrolled and not randomized or double-blinded.
Ovatio DR and Ovatio VR are two models of implantable cardioverter defibrillators developed by LivaNova PLC. They are studied together in the same clinical trial, NCT00586378, for the indication of sudden cardiac death. The 'DR' and 'VR' designations likely refer to different device configurations, but the specific differences are not detailed.