St. Jude Medical wins European approval on defibrillators, U.S. versions to launch this year

St. Jude's Unify defibrillator

ST. PAUL, Minnesota — St. Jude Medical Inc. has received European approval to begin selling two defibrillators that it says have the industry’s “smallest available device footprint.”

The company expects to begin selling its Fortify and Unify defibrillators in Europe this spring, and the U.S. versions later this year, according to a statement from the company. A defibrillator is a device that can be implanted in a patient’s body to deliver electric shocks to correct an abnormal heartbeat.

Because the devices are narrower than other defibrillators, surgeons are able to make shorter incisions, which results in smaller scars for patients. The devices also monitor pulmonary congestion, alerting physicians when a patient’s heart failure may be worsening, according to the statement.

The Fortify is designed to treat abnormally fast heart rhythms, which can lead to sudden cardiac death. The Unify resynchronizes the beating of the heart’s lower chambers, which often beat out of sync in heart failure patients, according to the statement.

“These new devices have been designed to address many of the clinical issues facing our customers, from enhanced patient safety, reduction of inappropriate therapy and streamlined implant procedures, to improved disease management of cardiac conditions,” said Dr. Eric Fain, president of St. Jude’s cardiac rhythm management division.

Neither device has been approved by the U.S. Food and Drug Administration.

On Wednesday, St. Jude said it had received FDA approval to begin enrolling patients in a clinical trial of a catheter system that uses radio frequency energy to destroy abnormal heart tissue.

Last week, the company reported that fourth-quarter sales in its cardiac rhythm management division fell 1 percent. The division’s annual sales grew 3 percent, most of it from international. U.S. sales were flat.