Sunshine Heart Inc. announced an update in late July on its COUNTER HF U.S. pivotal study for the C-Pulse Heart Assist System. COUNTER HF is a prospective, randomized, multi-center, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of New York Heart Association (NYHA) Class III and ambulatory Class IV heart failure. The study was temporarily paused this past March after the company notified the U.S. Food and Drug Administration (FDA) of four deaths in the treatment arm of the study. The deaths were adjudicated as not device- or therapy-related, and as previously announced on May 26th, the FDA approved resumption of patient enrollment in the study.

Biotronik announced that the first patient has been enrolled in the BioCONTINUE clinical trial (BIOtronik study to assess the CONTINUation of Existing risk of ventricular arrhythmias after CRT-D replacement). BioCONTINUE is the first study to investigate the relevance of defibrillator back-up following first device replacement in a heart failure (HF) patient population with a primary indication for a cardiac resynchronization therapy defibrillator (CRT-D).

The Centers for Medicare & Medicaid Service (CMS) announced that over 2,100 healthcare facilities have agreed to participate in the Bundled Payments for Care initiative to improve care and reduce costs for Medicare. Participants — which include acute care hospitals, skilled nursing facilities, physician group practices, long-term care hospitals, inpatient rehabilitation facilities and home health agencies — have transitioned from a preparatory period to a risk-bearing implementation period in which they assumed financial risk for episodes of care.

Medtronic plc announced that the first two European patient cases with the Endurant Evo AAA stent graft system were successfully performed at the Erasmus Medical Center in Rotterdam, Netherlands. Both procedures were performed by Prof. Hence Verhagen, M.D., Ph.D., chief of vascular surgery, and his team.

In an effort to demonstrate how 3-D printing can help better interpret medical imaging, Philips teamed up with 3-D printer manufacturer Ultimaker to create detailed replicas of Philips magnetic resonance imaging (MRI) scans. The replicas were displayed at the 2015 International Society for Magnetic Resonance in Medicine (ISMRM) annual meeting in Toronto, May 30-June 5.