The U.S. Food and Drug Administration (FDA) granted market clearance for Cook Medical’s Zilver PTX drug-eluting peripheral stent. It is the first device of its kind on several fronts to go before FDA review. It is the first drug-eluting stent (DES) for peripheral leg vessels, the first self-expanding DES and the first DES that does not use a polymer to load and elute its drug.

November 14, 2012 — Vital Images received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for 3-D viewing through its universal viewer, VitreaView. The company also released tablet viewing capabilities for VitreaView.

November 14, 2012 — Medtronic Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Valiant Captivia stent graft system for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta.

Magnetic resonance imaging (MRI) is more effective than electrocardiography (ECG) at identifying "silent" heart attacks, also known as unrecognized myocardial infarctions, according to a study performed by National Institutes of Health researchers and international colleagues.

November 14, 2012 — Two years after the joint launch of Optima MR360 and Brivo MR355, GE Healthcare announced a major milestone with the 500th shipment of these products combined, making the duo one of the fastest in GE MR (magnetic resonance) history to reach this milestone. This GE exclusive combines the speed and high resolution of an ultra-high field system with the breadth of imaging capabilities that increase the versatility of the system.

November 12, 2012 — Abiomed Inc. said it received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for the use of the new Impella RP (right-side percutaneous) in a pivotal clinical study in the United States.
Boston Scientific Clinical Trial Implantable Cardioverter Defibrillator

November 12, 2012 — Boston Scientific Corp. and the University of Rochester Medical Center presented positive results from the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) clinical trial that demonstrated improved programming of Boston Scientific dual-chamber implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) heart devices can reduce inappropriate therapy and risk of death.
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