Cardiac resynchronization therapy (CRT) devices are implanted into heart failure patients to try to improve the efficiency of the heart. How well the therapy ends up working depends very much on the positioning of the electrodes of the leads that stretch into the heart. Quadripolar leads, having two more electrodes than typical, provide a great deal of control to cardiologists to stimulate the heart from different spots, but they typically still suffer from too much physical movement.
Medtronic just won FDA approval for the Attain Stability Quad MRI SureScan left heart lead that’s used with the company’s quadripolar CRT-defibrillators (CRT-D) and CRT-pacemakers (CRT-P). Unlike other quad leads, the newly approved device features a special helical mechanism that expands to attach the lead within the vessel. The mechanism works in a wide variety of vein sizes, helping to secure the lead and provide cardiologists with consistent results when programming the CRT pacemakers and defibrillators. As a matter of fact, the Attain Stability Quad MRI SureScan is the only left heart lead with an active fixation device.
“Appropriate placement of left heart leads during implantation of CRT devices is critical to achieve the clinical benefits of this therapy. Unfortunately, with present passive-fixation leads, we are not always able to position the lead in an ideal location due to variations in a patient’s anatomy and size of the target vessel. We also continue to see lead dislodgements that require reprogramming or repeat surgery for lead repositioning. Having a new active fixation left heart lead allows us to target the ideal location in the patient’s vessel with the confidence that the lead will remain in place to allow for continued effective delivery of CRT,” said Steven Zweibel, M.D., director of Electrophysiology at the Hartford Healthcare Heart and Vascular Institute, in a published piece.
As the name implies, the lead is also compatible with MRI scanners up to 3 Tesla, as long as the accompanying electronic implant is also MRI-conditional for the same magnet strength. This leaves patients with the option to receive MRI scans when necessary, an important diagnostic modality for all sorts of conditions.
The device will be made available in the U.S. this coming summer. In Europe it has been cleared for almost two years now.