The U.S. Food and Drug Administration (FDA) has approved Covidien’s Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. This generic product from the company is pharmaceutically equivalent to Cardiolite®1, a myocardial perfusion imaging agent that is used to detect coronary artery disease. The kit from Covidien will now be available in the market of United States.

InspireMD has achieved positive results with its MGuard coronary stent in an ongoing multicenter trial aimed at establishing the safety and efficacy of the product in high-risk patients with complex lesions. The study’s six-month data demonstrates no thrombosis and an overall MACE rate of 6.6%. The data also highlight the efficacy of MGuard in maintaining blood flow through the treated vessel after six months, according to the company. The product, which combines a coronary stent with an embolic protection device, has received a CE Marking to treat patients with coronary artery diseases.