First US treatment with Medtronic's heart device:
This article was originally published in Clinica
Cardiologists have successfully implanted Medtronic's InSync device for treating heart failure, the first implant of the device in the US. The device, designed to synchronise the beating of the right and left side of the of the heart, as well as the upper and lower chambers, uses three transvenous leads to stimulate three chambers of the heart. Stimulation of the left ventricle is achieved via a lead passed through a coronary vein on the surface of the heart and therefore avoids open chest surgery. The InSync device is already available in Europe, said Minneapolis-based Medtronic.
You may also be interested in...
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.
Rushed final rule seeking to impose draconian cuts on drug reimbursement rates in the Medicare Part B program is certain to face legal and political obstacles. But the data included on international price benchmarks will still have an impact.