• St. Jude Medical(St. Paul, Minnesota) reported FDA approval of its Frontier II system for cardiac resynchronization therapy pacing (CRT-P) to reduce the symptoms of moderate to severe heart failure (NYHA Class III or IV) in patients who remain symptomatic despite optimal drug therapy. The Frontier II system is currently the only device family ap-proved in the U.S. for treating patients (NYHA Class II or III) who have undergone an AV nodal ablation for chronic atrial fibrillation. The heart failure indication expands the number of patients who are eligible to have the device implanted. St. Jude said the Frontier II device is the smallest and longest-lasting CRT pacemaker in the U.S., which gives physicians flexibility to optimize patient care without compromising size or longevity. Among the advanced technologies offered in the U.S. version of the Frontier II CRT-P are independently programmable right ventricle and left ventricle amplitudes and pulse widths to meet the individual energy requirements of each chamber of the heart and maintain capture; negative AV/PV Hysteresis and DDT/R Modes Trigger designed to maximize biventricular pacing; and a comprehensive set of atrial fibrillation diagnostics.

Spectranetics (Colorado Springs, Colorado) said it has received 510(k) clearance from the FDA to market its enhanced lead-locking device (LLD E) featuring design enhancements that it said will save deployment time, improve navigation through tortuous vascular anatomy and provide additional stability to the pacemaker or defibrillator lead being removed. The device was launched earlier this month at the Heart Rhythm Society meeting in New Orleans. The LLD E may be used alone or in combination with the Spectranetics Laser Sheath. Together, these devices are marketed as CLeaRS (Cardiac Lead Removal System). The LLD E uses Spectranetics’ technology that locks onto the entire working length of the inner wall of the lead being removed, providing a stable platform for the lead extraction.