Medtronic gains FDA approval of Viva CRT-D devices and Evera ICDs

Medtronic on Monday announced FDA approval and the US launch of its Viva portfolio of cardiac resynchronisation therapy with defibrillation (CRT-D) devices and the Evera portfolio of implantable cardioverter-defibrillators (ICD). "It's more cost-effective than the older technology," noted David Steinhaus, Medtronic's medical director for cardiac rhythm disease management, adding that "these devices are designed to provide optimal therapy for patients, while providing economic benefits through fewer hospitalisations, fewer inappropriate shocks, and increased longevity."

Significantly more patients with heart failure responded to treatment and they were 21-percent less likely to be hospitalised in the first year after implantation than those with older devices, said Steinhaus. The improvements lead to $1600 in cost savings per patient over the life of the device, Steinhaus added. The products are the first to make a marked improvement in the number of patients with heart failure who respond to treatment since the synchronisation devices were approved more than a decade ago, he noted.

Medtronic said that both devices feature a contoured design that reduces skin pressure by 30 percent and are equipped with SmartShock shock reduction technology to better differentiate between dangerous and harmless heart rhythms. Additionally, the company said the devices deliver up to a 25-percent increase in battery longevity, compared with previous devices, and are paired with the Sprint Quattro Secure lead.