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.

At the Boston Atrial Fibrillation (AF) Symposium 2013, Philips Healthcare introduced its latest innovations in advanced imaging integration for electrophysiologists, showcasing its new EP navigator offering — a novel approach to 3-D rotational angiography that provides real-time anatomical details of cardiac LA-PV structures with significantly enhanced workflow.

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.

nContact Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s modifications to its VisiTrax cardiac ablation device, EPi-Sense, now with embedded sensing capability. This next generation of technology includes sensors along the ablation device, which provide real-time feedback to physicians conducting cardiac ablation procedures.

 

CardioMEMS Inc. has been honored as the 2012 recipient of the Intel Innovation Award. Founder and CEO Jay Yadav, M.D., was presented with the award on Dec. 4, 2012 during the annual Health IT Leadership Summit held at the historic Fox Theatre in Atlanta, Ga.


CardioKinetix Inc. announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute Ventricular Partitioning Device for the treatment of heart failure.


GSI Group Inc., a leading supplier of laser-based solutions, precision motion and optical technologies to global industrial, medical, electronics and scientific markets, announced that it has acquired NDS Surgical Imaging (NDS), a San Jose, Calif.-based global leader in surgical and radiology displays and related peripherals, for $82.5 million in cash, subject to customary closing adjustments.

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