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 press release.
Because the devices are narrower than other defibrillators, surgeons are able to make shorter incisions, which lead to 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. Neither device has been approved by the Food & Drug Administration.
It’s the second regulatory nod for St. Jude in as many days. The company won FDA approval to begin enrolling patients in a clinical trial of a catheter system that uses radio frequency energy to destroy abnormal heart tissue Feb. 3.
Late last month St. Jude reported that fourth-quarter sales in its cardiac rhythm management division fell 1 percent. The division’s annual sales grew 3 percent, most if it from international. U.S. sales were flat.