January 21, 2013 — ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, recently evaluated evidence behind the use of the only transcatheter heart valve approved for marketing in the United States and Europe in transcatheter aortic valve implantation (TAVI).

The first patient has been treated in the Boston Scientific Corporation ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer open-irrigated temperature ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation. This international, multi-center study will include up to 33 sites in the United States, Europe and Asia-Pacific, and as many as 472 patients. The results of the ZERO AF trial are expected to be used to support a U.S. Food and Drug Administration (FDA) regulatory submission for a paroxysmal atrial fibrillation indication.

GE Healthcare announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility. Optison is a contrast agent that may improve the visualization of the left ventricular border — an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. Upon approval, GE Healthcare will provide supply of Optison to the U.S. market from its manufacturing facility in Oslo, becoming the only contrast media manufacturer to supply its own stock for the United States.