Medtronic Faces Threatening Competition in the Leadless Pacemaker Market - Gadgets Price
Medtronic Faces Threatening Competition in the Leadless Pacemaker Market

Five years ago, the FDA approved Medtronic’s Micra, the first leadless pacemaker to hit the US market. Touted as the world’s smallest pacemaker, the Medtronic device represented a major innovative leap in pacemaker technology. The device also became a golden example of how medical device manufacturers continue to push the boundaries of what is possible in medtech miniaturization.

While Medtronic remains the only company with FDA approval for a leadless pacemaker, both Boston Scientific and Abbott are racing to bring a competitive device to the US market. The Cleveland Clinic implanted a defibrillator system for leadless pacemakers developed by Boston Scientific in the world’s first two patients as part of a global clinical trial. And last month, data from a global study evaluating Abbott’s Aveir leadless pacemaker was published in the Journal of the American College of Cardiology: Clinical Electrophysiology, and Abbott said the data has also been submitted to the FDA in support of approval.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat slow heartbeats, and nearly 1 million people worldwide have a pacemaker implanted each year. The lead in a traditional single-chamber pacemaker extends from the pacemaker generator, which is implanted under the skin near the collarbone, through a vein and terminates in direct contact with the right ventricular wall of the heart. The lead delivers electrical pulses from the generator to the right ventricle and helps coordinate heart rate timing. A leadless pacemaker is designed to be self-contained and implanted directly into the right ventricle of the heart, as shown in the figure below.

Image Courtesy of MedtronicMedtronic Micra Leadless Pacemaker implanted in the heart.

The Leadless II study analyzed safety and efficacy endpoints in 200 patients implanted with Abbott’s Aveir leadless pacemaker at 43 centers in the United States, Canada and Europe. The patients were followed for six weeks. The Aveir leadless pacemaker was successfully implanted in 98% of patients. At six weeks, 96% of patients met the safety endpoint of no serious adverse events, and 95.9% met the efficacy endpoint of acceptable therapy delivered to the patient. The company also noted that in 96% of clinical cases, physicians were able to accurately position the device the first time or with a single repositioning.

“When we developed the Aveir leadless pacemaker platform, our fundamental premise was to design a device with longer battery life that can be retrieved and expanded with future innovations, and can provide better patient outcomes with a minimally invasive implant procedure,” said Randel. Woodgrift, senior vice president of heart rhythm management at Abbott. “The results of the Leadless II study are a strong indicator that once the device is approved, the Aveir system could help physicians manage the care of patients with certain abnormal heart rhythms.”

Boston Scientific’s device has the potential to really set itself apart from the Medtronic Micra and the Abbott Aveir, as it consists of two heart rhythm management (CRM) devices that are intended to work together to coordinate therapy: the MRI logo. Subcutaneous Implantable Defibrillator (S-ICD) System and the Empower Modular Stimulation System (MPS). The combination device would be the first leadless pacemaker to provide both bradycardia pacing and anti-tachycardia pacing (ATP) support.

“Since the Empower MPS device can be delivered percutaneously through a minimally invasive approach without the use of leads, the mCRM System could retain many of the benefits of the S-ICD System, while providing an option for patients who subsequently develop a stimulation requirement.” said Kenneth Stein, MD, senior vice president and chief medical officer for rhythm management and global health policy at Boston Scientific. “The system’s components are designed to work together regardless of when they’re implanted, giving physicians the ability to provide personalized patient care today, while leaving options open in the future.”

The MODULAR ATP prospective, non-randomized clinical trial is expected to enroll up to 300 patients at up to 50 centers in the United States, Canada and Europe. Patients participating in the study include those who are indicated for an ICD according to the guidelines or who already have a Emblem or Emblem MRI S-ICD System implanted. The trial evaluates the system- and procedure-related complication-free rate of the Empower MPS, the communication success between the Empower MPS and the S-ICD System, and adequate stimulation thresholds of the Empower MPS.

FDA highlights rare (but serious) complication risk associated with leadless pacemaker systems

The FDA recently pointed to the risk of serious complications if heart perforation occurs during the implantation of a leadless pacemaker. Although cardiac perforation is a rare complication (occurring in approximately 1% of cases) of any pacemaker implant procedure, field data suggest that the risk of serious complications following cardiac perforation may be higher in patients receiving a cordless pacing system than with a traditional transvenous pacemaker . The agency encouraged physicians to report cardiac perforations from leadless pacemakers and related complications to the device manufacturer and the FDA.

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