Guidant Corporation has received Conformité Européenne (CE) Mark approval to launch its CONTAK RENEWAL 4 cardiac resynchronization therapy defibrillators for use outside the United States.
The company had voluntarily removed devices from implant and distribution last month. After further testing and evaluation of the CONTAK RENEWAL 3 and 4 cardiac resynchronization therapy defibrillators, the company has identified a solution that resolves the device performance and quality concern of the magnetic switch component failures. Manufacturing of these products has now resumed and Guidant anticipates product availability for implants in markets with regulatory approval in August.
“The health and safety of patients is our top priority,” said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. “We are extremely pleased that Guidant engineers have identified a path forward to resume distribution and implant of these devices.”