The FDA has given Medtronic approval to bring to U.S. market its Consulta and Syncra cardiac resynchronization therapy-pacemakers (CRT-P).
Consulta is the first CRT-P that includes Medtronic‘s exclusive OptiVol® Fluid Status Monitoring, which identifies patients at risk for worsening heart failure before symptoms develop. Additionally, both Consulta and Syncra are the first CRT-Ps that include Leadless ECG Waveform, which together with the Medtronic CareLink® Network device data monitoring system, offer the possibility of remote follow-up in heart failure patients implanted with these devices.
Both next-generation systems are the most comprehensive cardiac resynchronization therapy-pacemaker systems offered by Medtronic, providing fully automatic capabilities and adaptive therapies that help to ensure CRT, even during atrial fibrillation, and enable physicians to monitor their heart failure patients in the office or remotely. Additionally, both systems include unique programming flexibility to avoid phrenic nerve stimulation, which helps prevent the need for more invasive surgical approaches.
While both Consulta and Syncra systems include the same technology, they have differentiating features. Consulta includes Medtronic’s exclusive OptiVol Fluid Status Monitoring, as well as Complete Capture Management™, which monitors and adjusts to patient needs automatically and can positively impact device longevity and reduce in-office testing.
OptiVol is an exclusive Medtronic technology that measures intrathoracic impedance in heart failure patients using very low electrical pulses that travel across the thoracic cavity (the chest area encompassing the heart and lungs). The system measures the level of resistance to the electrical pulses, which indicates the patient’s fluid levels.
Complete Capture Management helps improve patient safety and preserve the longevity of the device by continuously and automatically adjusting the pacing of the device to changing patient physiologic needs. Complete Capture Management also provides flexibility for clinicians so they may eliminate certain manual checks and devote more time to patients, procedures and complex cases.
Press release: Medtronic Announces FDA Approval of Consulta® and Syncra™ Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Systems
Product page: Consulta Cardiac Resynchronization Therapy Defibrillator;