Medical Device Daily Associate

Medtronic (Minneapolis) reported the market introduction of its portfolio of what it says is the first fully automatic pacemaker line that also incorporates a feature to reduce unnecessary pacing.

The Medtronic Adapta, Versa and Sensia pacemaker systems provide physiologic pacing adapted to the “needs of individual patients,” which the company said will help set new standards of care that reduce unnecessary pacing when the heart's natural conduction is present. The portfolio recently received FDA approval.

“The pacemaker offers the ability not to pace the heart when it does not have to – which can be detrimental,” said John Andriulli, MD, assistant professor of medicine, director of the arrhythmia device program at the University of Medicine and Dentistry of New Jersey, Cooper University Hospital (Camden, New Jersey).

The system is able to achieve this via the company's pacing mode called Managed Ventricular Pacing (MVP), which enables the device to be programmed to deliver pacing pulses to the heart's lower right chamber (ventricle) only when necessary. MVP has been shown to reduce unnecessary right ventricular pacing by 99% (median value). Recent clinical studies have suggested that reducing this pacing stimulation may reduce the patient's risk of developing heart failure and atrial fibrillation, a potentially life-threatening irregular heartbeat.

The new pacemaker systems also incorporate an array of automatic features to help physicians improve pacing therapy and streamline the patient follow-up process, potentially minimizing the amount of time spent in a physician's office. The Adapta, Versa and Sensia pacemakers are completely automatic and include the Medtronic-exclusive feature Atrial Capture Management (ACM). ACM is intended to automatically adjust impulses for optimal stimulation of the heart's upper right chamber (atrium).

Since the device offers “full automaticity,” meaning that the pacemaker will adjust itself for the various pacing thresholds, Andriulli told MDD that this new family of pacemakers is ideal because it automatically adapts to changing parameters in a non-compliant patient, or patients who are somehow lost to follow-up.

“The device will automatically adjust itself to extend battery longevity for as long as it can without manually being programmed,” he said. He added that the device can also adjust for a dislodged lead or in the case of a faulty lead, the system can actually adjust the polarity of the defective lead.

“Full automaticity allows both for patient safety and allows for physicians when they follow the device to have all this information on one screen to be delivered to the physician without doing any manual testing at all,” Andriulli said. With this new pacemaker line, “he added, “the [physician] programming burden to try to reduce ventricular pacing is no longer.”

Another key component of these pacemakers is their ability to utilize the company's CareLink system to remotely follow patients.

“You can follow pacemakers now via CareLink and get all the information you need to get automatically without the patient having to be physically present in the doctor's office.”

Andriulli, who was involved with the design of the Adapta pacemaker line, said that the system is able to self-maintain because its algorithms allow it to continuously monitor the P waves and R waves and also has what he called atrial and ventricular capture management “to actually look at the exact threshold to where the device loses capture and it has the ability to set itself above that threshold in order to maintain the adequate safety margins to maintain capture as well as giving us the best longevity for the device itself.”

While he noted that the MVP mode was previously introduced in Medtronic's EnRythm pacemaker line, he pointed out that the Adapta portfolio is the first line of devices to incorporate the full automaticity features.

For the physician, Andriulli said the ability to “maximize your time with the patient as opposed to maximizing your time with the device,” is a big key to why he believes that the Adapta family of pacemakers with the combination of the MVP mode and full automaticity “should be standard-of-care in the pacemaker industry.”

The company said it initially will be charging a premium for the Adapta devices, but Andriulli said he expects that pricing to level off once, as he believes, these systems become a standard of care.