Wireless Pacemakers Receive FDA Approval

Two wireless-ready pacemakers made by St. Jude Medical Inc. have been approved by the Food and Drug Administration.

The pacemakers, called the Accent RF and the Anthem RF CRT-P, have the ability to communicate wirelessly with clinicians at a hospital or by using an in-home monitor. Using the wireless pacemakers allows physicians to implant the device in patients and monitor the devices while patients are at home or on the go, without requiring frequent in-office follow up visits.

“The pacemakers were designed in response to physician and patient needs for devices that provide timely, actionable information,” said Eric Fain, president of the St. Jude Medical Cardiac Rhythm Management Division.

The devices give both clinicians and patients more freedom from frequent in-office appointments, officials said.

“Using the remote monitoring capabilities, physicians can more efficiently follow patients, while patients enjoy the convenience of care from home,” Fain said.

Other Pacemaker Problems

Pacemakers, tiny devices used to regular the heart and correct irregular heartbeats (arrhythmia), have been the source of problems before.

Medtronic, a leading maker of pacemakers and other medical devices, recently recalled about 21,000 of its pacemakers because of defects in the internal wiring that could prevent them from working properly.

Also, tiny wires called leads that connect defibrillators to the heart have been recalled over the years because they might fracture and either fail to deliver a life-saving shock when needed or shock the heart when it is not needed to correct arrhythmia. Medtronic Sprint Fidelis defibrillator leads were recalled in 2007 after patients complained that they did not work properly. At least five patients died as a result of defective Sprint Fidelis leads.

No related posts.