• Kensey Nash(Exton, Pennsylvania) reported the final results of the FIRST (First European Investigation Regarding the Systematic use of the TriActiv Device) study, which was designed to examine cost-effectiveness of its TriActiv System in saphenous vein graft patients to support reimbursement for the device in Germany and European countries. The data was presented at the recent German Society of Cardiology meeting in Mannheim, Germany. TriActiv is an embolic protection system used during saphenous vein graft interventions to minimize major complications and is commercialized in both the U.S. and Europe. The FIRST study results showed that the TriActiv system substantially reduced 30-day MACE (major adverse cardiac events) compared to a historical control of patients treated without embolic protection. The reductions in complication rates will be used to generate a cost-effectiveness analysis of the TriActiv system. The FIRST study enrolled 196 patients at 17 sites in Germany.

• Medtronic (Minneapolis) reported receiving approval from the FDA to add sequential biventricular pacing, known as V-V (ventricle-to-ventricle) timing, to its InSync Sentry and InSync Maximo cardiac resynchronization therapy defibrillators. V-V timing allows physicians to separately adjust the timing of electrical therapy delivered to the heart failure patient’s two ventricles, which can optimize the beating of the heart and enhance the flow of blood throughout the body. Starting in the next two weeks, shipped InSync Sentry and InSync Maximo devices will include V-V timing. The company said it would release special software to allow patients who already have a previous model of these devices to benefit from the feature through a simple, in-clinic software programming change. In addition, the FDA approved a labeling modification for InSync Sentry and InSync Maximo systems to include use for heart failure patients who have prolonged QRS duration.

• Osteotech (Eastown, New Jersey) reported the market release of a new addition to its Grafton Demineralized Bone Matrix (DBM) product line. Grafton DBM Orthoblend consists of two formulations; one for large defects containing demineralized bone fibers with cancellous chips and one for smaller defects containing demineralized bone fibers and crushed cancellous chips. Both product formulations eliminate the need for the surgeon to mix ingredients intra-operatively which saves time and eliminates variability in product consistency that can occur with hand mixing. Grafton DBM Orthoblend is consistent with the rest of the Grafton DBM line of products in terms of osteoconductive and osteoinductive properties, the company said.