Medtronic has begun shipping its Consulta and Syncra cardiac resynchronization therapy-pacemaker (CRT-P) systems now that the FDA given its blessing for the products.
Consulta is the first CRT-P that includes Medtronic‘s OptiVol fluid status monitoring, which identifies patients at risk for worsening heart failure before symptoms develop, the company says in a statement. And 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 resynchronization therapy; therefore, there is a real need for next-generation devices that can deliver lifesaving CRT in this patient population," says Robert Canby, Texas Cardiac Arrhythmia and Seton Medical Center, Austin, TX, in a statement. "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."
As MedCity News notes, approval of Consulta, Syncra and other Medtronic devices had been held up recently as the company resolved FDA warning letter issues involving some of its manufacturing facilities.
The CRDM business, which constitutes just under a third of Medtronic's total revenues, declined two percent year over year during the Q3 2011 due to slower market growth and pricing pressure, as Zack's Investment Research notes. So these approvals could be a big win for the company as it tries to reinforce its leadership as it battles for market share against Boston Scientific and St. Jude Medical, Zack's adds.