FDA approves devices by Medtronic, Biotronik

The FDA added several options for physicians who treat patients with heart failure and arrhythmias with its back-to-back approvals of two implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) technologies.

Minneapolis-based Medtronic announced May 6 that it received the go-ahead from the FDA to launch the Viva portfolio of CRT-D devices and the Evera portfolio of ICDs. The Viva CRT-D and Evera defibrillation devices use a contoured design that reduces skin pressure by 30 percent, offer greater battery longevity and provide advanced shock reduction technology, according to Medtronic.

On May 7, Biotronik reported that the agency gave thumbs up to its Ilesto 7 ICD/CRT-D series. The move follows the February approval of Biotronik’s Lumax 740 DX System, an ICD that uses a single lead with atrial sensing capabilities.

The company, which is headquartered in Berlin, said the Ilesto devices are smaller, thinner and lighter. The Ilesto DX version will be the first ICD launched in the series, according to Paul Woodstock, executive vice president of sales and marketing at Biotronik USA.