Medtronic Device for Heart Failure gets approval in the US
Medical device maker Medtronic said on Tuesday that the U.S. Food and Drug Administration had approved its implantable heart defibrillator with resynchronization therapy for a wider group of patients.
The FDA approved the device, known as CRT-D, for heart failure patients with mild symptoms. This treatment potentially can improve survival, reduce hospitalisations and prevent the disease from getting worse, Medtronic said. The latest approval could increase the number of patients eligible to get the device by 620,000 worldwide, including nearly 200,000 in the United States, the company said.
Heart failure affects more than 22 million people worldwide, including around 1 million in the UK and more than 5.8 million in the United States. Previously the defibrillators, which help the heart’s lower chambers beat in a more synchronized way, were only approved by the FDA to treat certain patients with moderate-to-severe heart failure.
While certain mildly-symptomatic heart failure patients could already receive an implantable defibrillator to protect them from sudden cardiac arrest, they are still vulnerable to a further weakening of their heart. CRT-D therapy works by sending electrical impulses to the heart muscles, improving the blood-pumping capability