Sunshine Heart Inc. announced it has received unconditional approval from the U.S. Food and Drug Administration (FDA) to conduct an interim analysis of COUNTER HF, the company's U.S. pivotal study.

In light of a recent American Heart Association report stating that U.S. mitral valve regurgitation prevalence was 1.7 percent in 2014, a significant opportunity exists for development of an effective transcatheter mitral valve replacement (TMVR) device as an alternative treatment to surgery for inoperable patients. This assessment was given by an analyst with research and consulting firm GlobalData.

The National Forum for Heart Disease & Stroke Prevention announced the launch of the Stronger Hearts Helpline, a 24/7 free call-center resource for people with heart failure and their families. The pilot program is an addition to the existing 2-1-1 information and referral hotline in San Bernardino County, California – a region where nearly 20 percent of Medicare recipients are being treated for heart failure – and long-term plans are to expand the service nationwide.

Medtronic announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved a transitional pass-through payment for the company’s IN.PACT Admiral drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system (OPPS). The decision removes a potential barrier to patient access to this new medical device, which represents an improvement to the standard of care for peripheral arterial disease in the upper leg.