FDA Approves St. Jude Cardiac System

St. Jude Medical received FDA approval for a connector system that allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator and the wires that send electrical impulses to the heart. Used to treat heart failure, the system reduces the volume of leads and devices in a patient’s chest pocket, which could reduce the risk of complications such as lead-to-can abrasion. The company will conduct a postapproval study with 1,700 patients for five years as part of the FDA’s requirement for the approval, St. Jude said.