• The FDA has authorized Phase 2 clinical trials for the BiVACOR mechanical heart, allowing 15 additional patients to receive the device and recover at home while awaiting donor hearts.
• The innovative BiVACOR device features a single moving part - a magnetically suspended spinning disc - potentially offering a more durable and permanent alternative to traditional heart transplants.
• The first human recipient, Batson Avie, experienced immediate improvement after implantation at Texas Heart Institute, demonstrating the device's promising potential for treating advanced heart failure.