A Medical Device Daily
Boston Scientific (Natick, Massachusetts) reported the FDA approval of its Altrua family of pacemakers, following on the heals of winning the CE mark.
The company says the Altrua is its most advanced pacemaker, delivering enhanced therapy with small size and battery longevity. It is the first Boston Sci-branded pacemaker to treat bradycardia — a condition when the heart beats too slowly, usually less than 60 beats per minute.
"FDA approval of [our] Altrua family of pacemakers — especially following the European approval of ALTRUA we announced yesterday [Medical Device Daily, May 8, 2008] — further demonstrates the significant progress we have made rebuilding our CRM organization and reinvigorating our product pipeline," said Fred Colen, executive VP, operations and technology.
The company cited a number of Altrua features:
• Multiple Atrial Ventricular (AV) Delay programming options, options designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats, "a key distinction from other competitive RV pacing algorithms." The Altrua 50 and 60 series include an enhanced AV search hysteresis feature, now with an extendable AV delay out to 400 milliseconds, providing additional flexibility to tailor device programming for unique patient needs.
• Minute Ventilation (MV) Blended Sensor, treating a condition called chronotropic incompetence, the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress. Boston Sci says its MV Blended sensor is the only sensor that has been shown to restore chronotropic competence.
• Ventricular Rate Regulation (VRR), which helps physicians manage patients with frequent atrial arrythmias.
• Automatic Capture, designed to offer automatic and accurate ventricular pulse management. The device checks every heartbeat to see if the lower chambers of the heart contract in response to the delivered pulse. If no contraction is detected, a backup pace with more energy is delivered.