The FDA Tuesday approved Medtronic’s Vision 3D portfolio of wireless implantable cardiac devices. David M. Steinhaus, MD, vice president and medical director of Medtronic’s cardiac rhythm disease management section, told Cardiovascular Business News that the single-platform devices are “game changers.”
The Vision 3D portfolio comprises a full line of implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy-defibrillators (CRT-Ds), pacemakers and cardiac resynchronization therapy-pacemakers (CRT-Ps). The portfolio’s first ICD and CRT-D devices will be commercially available in the coming months, according to Medtronic.
The Vision 3D combines for the first time the “brady with the tachy ICD platform,” which allows screen and programming uniformity for the pacemaker and the defibrillator, Steinhaus said. “One doesn’t have to make any compromises with the way the device paces compared to using just a defibrillator alone,” he said.
One of the “game-changing” aspects of the Vision 3D is complete capture management, which enables capture management in three chambers. The device senses and adjusts the energy level needed to pace each chamber, which helps preserve battery life because it allows pacing outputs to be low, Steinhaus said.
Since the device is constantly monitoring itself, it also will alert the physician via the internet if the patient has any new arrhythmias.
Medtronic is conducting a study to determine the importance of earlier detection of arrhythmias. For example, the ICD might detect an atrial fibrillation while the patient is sleeping. While it may not be life-threatening, the physician might want to alter therapy, start the patient on a blood thinner, Steinhaus said. The physician also might not even need to see the patient in the office, since all this information is delivered remotely.
“We are entering into a phase where we are managing chronic disease better than we have done before,” he said.
Besides the obvious clinical benefits, patients can feel more confident that their cardiac health is being constantly monitored while enjoying the convenience of not needing to travel to the doctor’s office. “In terms of physician efficiencies in the practice, think about what it takes to bring a 75-year-old patient into the practice—the front desk, nurses, the administrators and the physician have to manually check the report with a nurse practitioner as opposed to just getting the report on the internet. There’s a huge efficiency for physicians,” he said.
Medtronic has ongoing studies that examine the ways various disease management will improve the bottom line in terms of healthcare cost. For example, the company is considering whether asymptomatic atrial fibrillation can be treated in a cost-effective manner. Such a patient is at risk for stroke, which has huge costs in terms of dollars and quality of life. But with an early warning, the physician can prescribe proper therapies to potentially prevent stroke, Steinhaus said.
All of the new devices within the Vision 3D portfolio platform are state-of-the-art, but the feature sets differ. Physicians can select any product with features for each patient’s individual health needs and pricing, Steinhaus said.
All Vision 3D ICDs have these features:
- Managed Ventricular Pacing allows physicians to reduce unnecessary pacing to the right ventricle;
- OptiVol Fluid Status Monitoring measures intrathoracic impedance – which correlates with fluid levels – in heart failure patients; and
- ATP during Charging automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while simultaneously preparing to deliver a shock to terminate a potentially fatal rhythm. Clinical studies have shown that 90 percent of fast heart rhythms have the potential to be terminated by pacing alone. This feature is also available in the CRT-Ds.
“The more premium the device, the more features it has,” Steinhaus said.