The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical ...
with the three-tier status system being expanded to a six-tier system. Patients with durable left ventricular assist devices were deprioritized and patients with acute mechanical circulatory ...
The anticipated product offering will complement our emphasis on the ventricular therapeutic market and expectation for continuing growth ... pericardial space of the heart and that it is intended ...