Sunshine Heart Inc. announced the U.S. Food and Drug Administration (FDA) has approved an amendment to the stopping rule criteria for the company's COUNTER HF pivotal study for its C-Pulse Heart Assist System. The agency has agreed to change this protocol from "all cause" deaths to specifically, mortality associated with device, procedure or therapy.

Extending clot-preventing dual antiplatelet therapy (DAPT) beyond the recommended 12 months after coronary stenting “should be considered” in patients at low risk for bleeding, investigators for the OPTIDUAL trial recommend.

Janssen Pharmaceuticals Inc. and its development partner Bayer HealthCare announced results from PMSS and XANTUS, real-world safety studies of rivaroxaban (Xarelto) in people with non-valvular atrial fibrillation (NVAF). The results found the rates and patterns of major bleeding in routine clinical practice were low (2.89 and 2.1 per 100 person-years, respectively) and generally consistent with those observed in Phase 3 clinical research.

Gene transfer therapy to correct an enzyme abnormality involved in myocardial contraction and relaxation did not improve outcomes in heart failure patients with reduced ejection fraction, results of the CUPID 2 study show.

Sorin Group announced the start of patient enrollment in its TRIUMPH-CRT clinical trial in Europe.