Home Latest News FDA approves Consulta and Syncra cardiac resynchronisation therapy-pacemaker (CRT-P) systems

FDA approves Consulta and Syncra cardiac resynchronisation therapy-pacemaker (CRT-P) systems

FDA approves Consulta and Syncra cardiac resynchronisation therapy-pacemaker (CRT-P) systems

Consulta and Syncra cardiac resynchronisation therapy-pacemaker (CRT-P) systems (Medtronic) have been approved by the FDA on 24 March 2011. 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.

“Atrial arrhythmias are the number one cause of reduced cardiac resynchronisation therapy; therefore, there is a real need for next-generation devices that can deliver lifesaving CRT in this patient population,” said Robert Canby, Texas Cardiac Arrhythmia and Seton Medical Center, Austin, Texas, USA. “These new innovative technologies allow physicians to proactively manage their heart failure patients, and offer cutting-edge features that contribute to patient safety and physician ease-of-use.”

Both next-generation systems are the most comprehensive cardiac resynchronisation 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.

Heart failure, which is typically a late manifestation of one or more cardiovascular disease, affects more than 22 million people worldwide, and accounts for nearly US$80 billion in cost each year, according to statistics from the European Society of Cardiology. It is also a leading cause of hospitalisation among people aged 65 years and older, and admissions for its symptoms have increased by 15% during the past 20 years.

About OptiVol fluid status monitoring

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 system measures the level of resistance to the electrical pulses, which indicates the patient’s fluid levels. Used in combination with the Medtronic Cardiac Compass Report, the ability of OptiVol to monitor fluid status over time can provide physicians with important insights in conjunction with ongoing monitoring of other patient symptoms, which may lead to timely clinical intervention. Currently, there are more than 125,000 patients globally implanted with this exclusive technology.

About Complete Capture Management

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.

About the Medtronic CareLink Network and remote monitoring

The Medtronic CareLink Network enables clinicians to remotely monitor patients who are implanted with cardiac devices, to help further manage a patient’s heart failure. It is the world’s largest and most widely used remote monitoring system for implantable cardiac device patients, with more than 4,000 clinics and 500,000 patients enrolled in 30 countries. The CareLink Network has registered more than 2 million patient data transmissions since the service’s inception in 2002.

Remote monitoring of devices allows clinicians to quickly and thoroughly review a patient’s device information, and facilitate a timely exchange of device information between various physicians involved in treating heart failure patients.