The device was built as a bridge to transplant for patients with end-stage heart failure. It is made of titanium and approximately the size of an adult’s fist.
California-based Reflow Medical gained the approval after submitting data from the DEEPER REVEAL clinical trial. The device was associated with a high success rate and improved outcomes in CLTI patients.
Rishi Wadhera, MD, MPP, MPhil, a cardiologist who also specializes in healthcare policy, spoke to Cardiovascular Business about the good, the bad and the unknown when it comes to private equity's role in cardiology.
Researchers tracked the rates of major gastrointestinal bleeding in patients with AFib randomized to receive edoxaban or a vitamin K antagonist after a successful TAVR procedure.