April 10 Medtronic Inc 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 mildly symptomatic heart failure patients. This treatment potentially can improve survival, reduce hospitalizations, and prevent disease progression, Medtronic said.
The latest approval would potentially increase the number of patients eligible for the advanced therapy 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 more than 5.8 million in the United States.
Previously, Medtronic's CRT-D devices were only approved to treat certain patients with moderate-to-severe heart failure.
While certain of the mildly symptomatic heart failure patients could already receive an implantable cardioverter defibrillator to protect them from sudden cardiac arrest, they are still vulnerable to a further weakening of their heart.
CRT-D therapy works by resynchronizing the contractions of both ventricles by sending electrical impulses to the heart muscles, improving the blood-pumping capability.
Shares of Medtronic were up 1 cent at $37.76 in trading before the market opened.