The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer Sheath’s hemostatic valve that prevents blood from flowing back through the valve, warning that it may fail due to an improper seal of the sheath hub. The agency said improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). The FDA warned the use of affected products may cause serious health consequences for patients, including death.

Chagas disease (ChD), an infectious parasitic disease transmitted primarily by triatomine insects, has become a significant public health problem in recent decades. While many ChD patients suffer only minor symptoms, 20-30 percent develop chronic heart disease (ChHD); the variety of possible abnormalities caused by ChHD requires understanding of how different imaging modalities can assist in diagnosis and treatment decisions. A new document, Recommendations for Multimodality Cardiac Imaging in Patients with Chagas Disease: A Report from the American Society of Echocardiography in Collaboration With the InterAmerican Association of Echocardiography (ECOSIAC) and the Cardiovascular Imaging Department of the Brazilian Society of Cardiology (DIC-SBC), aims to provide the first comprehensive guidance for how best to use the multiple cardiac diagnostic tools to assess and monitor the growing number of patients with these Chagas-induced heart problems.

RenalGuard Solutions Inc. reported positive results from a first-in-man feasibility study focusing on a novel use of the RenalGuard System to manage fluids during diuretic therapy in congestive heart failure patients suffering from fluid overload. The results were recently presented at the annual Devices in Heart Failure (D-HF) Congress, Dec. 15-16 in Berlin, Germany, by Prof. Piotr Ponikowski, M.D., of the Wroclaw Medical University, Poland, and Prof. Felix Mahfoud, M.D., of the Saarland University Hospital, Homburg, Germany.

December 29, 2017 — iVascular announced the release of the new Oceanus 14 Pro percutaneous transluminal angioplasty (PTA ...

Vivasure Medical announced in October the successful enrollment of the first patient in the Frontier IV clinical study, a non-randomized multicenter international trial, designed to expand the indications of the PerQseal large arteriotomy closure technology. The patient was enrolled by Peter Crean, M.D., at the Blackrock Clinic, Dublin, Ireland.

Corindus Vascular Robotics Inc. announced recently that Houston Methodist DeBakey Heart & Vascular Center has launched the first vascular robotic program in the Houston area with the installation of two Corindus CorPath GRX Systems. In addition and as part of the program launch, Corindus will partner with Houston Methodist to develop a Global Center of Excellence that will seek to advance clinical research on robotics and to train interventional cardiologists on robotic-assisted percutaneous coronary interventions (PCI).

HeartFlow Inc. announced that Health Care Service Corp. (HCSC), which operates Blue Cross and Blue Shield plans in five states, has issued a medical policy for the HeartFlow FFRct Analysis, a non-invasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). HCSC — which operates Blue Cross Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas — has determined that the use of noninvasive fractional flow reserve (FFR) following a positive coronary computed tomography (CT) angiogram may be considered medically necessary to guide decisions about the use of invasive coronary angiography in patients with stable chest pain at intermediate risk of CAD.