Reference devices, not CardiaNova
เงื่อนไขที่อุปกรณ์ทำงานล้มเหลว สาเหตุ และเอกสารอ้างอิงทุกรายการ
This lists what the manufacturer's instructions, the inventor's patents and a published paper say can go wrong with two other teams' devices. It is not a failure analysis, not a risk estimate for any patient, and not a CardiaNova result. Every statement carries its source key; a page link opens that document at the cited page.
Percent of patients with the event in the first 6 months of the approval trial (MOMENTUM 3, short term cohort, as treated: 151 HeartMate 3 and 138 HeartMate II patients), as the FDA summary prints it. A 6 month figure, not a lifetime risk. No event rate for BiVACOR is public.