Abbott is promoting the health economics of its Supera Stent for peripheral artery disease, pointing to a yet-to-be-published study which found that the device is cost-effective because it reduces the need for interventions compared to competing therapies, like Medtronic's Protégé bare-metal peripheral stent and In.Pact Admiral drug-coated balloon.
Obesity treatment devices have been in the regulatory spotlight in 2015 with two approvals for balloon-based devices and another for a neurostimulator. That makes for a total of 5 FDA-approved obesity devices--including the two banding devices that were already approved.
A study presented at the annual meeting of the American Academy of Ophthalmology found that programmable electronic glasses help improve vision in children.
Medtronic's leadless pacemaker performed well in a 725-person clinical trial for FDA approval in the U.S., where the bigwig is racing with St. Jude Medical to become the first to sell such a device.
St. Jude Medical touted a study in the journal The Lancet, which found that the company's CardioMEMS Heart Failure System for monitoring heart failure led to a 48% decrease in hospitalizations.
An analysis of registry data shows that medical community efforts to reduce the number of inappropriate stenting procedures have worked. Between 2010 and 2014, the rate of inappropriate nonacute percutaneous coronary interventions to implant stents has fallen from 26.2% to 13.3%, according to a paper in the Journal of the American Medical Association presented at the annual meeting of the American Heart Association.
Functional Neuromodulation, a startup backed by Medtronic and the National Institutes of Health, will advance its deep brain stimulation implant into a Phase III trial to treat Alzheimer's disease patients. DBS is a standard treatment for movement disorders, such as Parkinson's disease, but hasn't been widely applied to other brain disorders.
Industry and the FDA are striving toward faster approval times counterbalanced by increased postmarket monitoring as they aim to optimize med tech regulation.
A NIH study came out in support of transcranial direct current stimulation, prompting the agency to say that the noninvasive stimulation technique has the potential to promote weight loss.
A Japanese study of intra-aortic balloon pumps appears to indicate the devices do little to improve outcomes for patients with acute cases and may increase the chances of death.