US health authorities on Friday approved a a heart defibrillator with leads that can be implanted just under the skin instead of connected directly to the heart.
The new subcutaneous device “uses a lead that is implanted just under the skin along the bottom of the rib cage and breast bone,” the Food and Drug Administration (FDA) said in a statement.
“Because the lead is placed under the skin rather than through a vein into the heart, a physician can implant the device without accessing a patient’s blood vessels or heart and without the need for fluoroscopy,” the FDA said. Until now defibrillators — small battery-powered devices that monitor a person’s heart rhythm and deliver small electric shocks to restore an irregular rhythm — were connected directly to the heart.
The delicate operation to implant traditional defibrillators have potentially grave side effects, such as an infection in an already weak patient.
“Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device,” said FDA official Christy Foreman.