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
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.