Sunshine Heart Inc. announced that the U.S. Food and Drug Administration (FDA) has reviewed the company’s submission regarding the pause of the COUNTER HF U.S. pivotal study. The FDA has requested minor protocol changes be submitted in order to receive approval to resume patient enrollment.

One life-threatening complication of lung cancer surgery is the formation of blood clots in the lungs (also called pulmonary embolism, PE) or in the legs (also known as deep vein thrombosis, DVT). Together, they would be defined as venous thromboembolic events (VTE). Several presentations at AATS 2015 shed new light on this serious problem. In the first prospective study of its kind, the incidence of VTE was found to be higher than previously reported, with a 5.4 percent VTE-specific mortality rate. Of concern to clinicians, most events were asymptomatic and occurred after patients were discharged from the hospital. The second report highlights the importance of screening for VTEs, especially since the majority of lower extremity VTEs found after pneumonectomy would have gone undiagnosed and untreated without screening. The third report describes a risk assessment tool for VTEs that is applied for the first time to predict an individual’s risk of VTEs after lung cancer surgery, which can help clinicians decide whether prolonged anti-clotting therapy is warranted.

AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for Brilinta (ticagrelor) tablets for patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrollment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015.

A key trial evaluating the Boston Scientific Eluvia drug-eluting vascular stent system met its primary endpoint, with more than 94 percent of the lesions treated for peripheral arterial disease (PAD) remaining open at nine months post implantation. This was accompanied by a target lesion revascularization rate (TLR) of less than four percent.