Medtronic has announced the market release of the CardioGuide Implant System, a novel real-time navigation system for cardiac resynchronisation therapy pacemakers and defibrillators (CRT-P and CRT-D), in the United States and Canada.
The system, developed by Paieon, helps physicians determine the most appropriate location for left-ventricular lead placement by generating 3-D images of the cardiac veins. The system also analyses the motion of select cardiac vessels on the left side of the heart. Clinical studies have shown that appropriate left-ventricular lead placement may improve cardiac resynchronisation therapy response in heart failure patients. According to the company, enhanced software for the system will be commercially available later this year.
“The future of LV lead implantation requires an individual-patient-tailored approach. We know from studies that the best location for one patient can be the least effective for another,” said Raymond Yee, director, Arrhythmia Service, London Health Sciences Centre, Ontario, Canada. “This system provides clinical and physiologic data acquired during the cardiac resynchronisation therapy case to ensure that the optimal lead and tools are used to implant the lead at the targeted location, potentially helping improve patient response to the therapy.”
Left-ventricular lead positioning is known to be time-consuming for physicians. According to the company, given its ability to guide lead placement in real-time, the CardioGuide System may help reduce overall implant procedure times.
“The CardioGuide Implant System offers the medical community a viable, cost-effective solution for targeting left-ventricular lead placement, the cornerstone of successful cardiac resynchronisation therapy,” said David Steinhaus, vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management business. “This is yet another example of our commitment to offering physicians the most advanced medical technology to help improve cardiac resynchronisation therapy response and ensure the best quality of care for all heart failure patients.”
The CardioGuide System is part of a comprehensive approach Medtronic has undertaken to deliver solutions to optimise cardiac resynchronisation therapy response and manage heart failure patients at every stage of care. The system is compatible with all Medtronic cardiac resynchronisation therapy devices, including the Viva/Brava portfolio available in Europe. The system received a Cardiostim Innovation Award from the European Society of Cardiology in 2012, and is available in the United States and Canada.
About the CardioGuide Implant System
The CardioGuide Implant System is designed to analyse fluoroscopy images and create 3-D imaging of the heart for transvenous left-ventricular lead implants. The components currently offered in the system include:
- CardioGuide software and work station, which includes a dedicated computer and monitor that are used to calculate anatomical measurements and provide lead navigation support.
- Physician monitor, which displays the implant system inside the procedure room or cath lab.
- Tablet computer, which includes a touch screen and stylus and is used as a tableside console in the procedure room.
- Markers that are placed on the patient’s chest to automatically calibrate the system.
Medtronic has an exclusive licensing agreement with Paieon to market the CardioGuide System worldwide.