Boston Scientific Wednesday received CE Mark approval, and simultaneously began the European launch of its Altrua family of pacemakers.
Altrua delivers enhanced therapies while maintaining its small size and battery longevity, according to the Natick, Mass-based company. It is the first Boston Scientific-branded pacemaker to treat bradycardia.
“European approval of Boston Scientific's Altrua family of pacemakers is the latest example of the significant progress we have made rebuilding our CRM [cardiac rhythm management] organization and reinvigorating our product pipeline,” said Fred Colen, executive vice president of operations and technology for CRM at Boston Scientific. “Altrua’s innovative technology -- enabling physicians to adjust the therapy to meet the needs of their patients -- demonstrates our renewed focus on treating bradycardia.”
The company said that the Altrua pacemaker provides physicians with a number of diagnostic and therapeutic capabilities for specific patient requirements, such as:
- Multiple Atrial Ventricular (AV) Delay programming options, designed to reduce unnecessary right ventricular pacing, without dropping ventricular beats. The Altrua 50 and 60 series also include an enhanced AV search hysteresis feature, now with an extendable AV delay out to 400 milliseconds;
- Minute Ventilation Blended Sensor, which treats chronotropic incompetence, the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress;
- Ventricular Rate Regulation, which manages patients with frequent atrial arrythmias; and
- Automatic Capture, designed to offer automatic and accurate ventricular pulse management.
Boston Scientific noted that FDA approval is pending for the Altrua family of pacemakers, which are not available for sale in the U.S.