Since the 1950s, pacemakers have been the standard of care for various bradyarrhythmias. Although various advances in technology have increased battery life and reduced the size of pacemakers to allow for implantation, lead failures and infections still occur in approximately 10 percent of patients that are implanted. Approximately 4 million pacemakers are currently implanted worldwide (750,000 annually), leading to 65,000 annual cases of lead failure.
With the recent development of leadless pacemakers, there is optimism that complication rates may be reduced in patients with implanted pacemakers. Two leadless pacemakers currently lead the way in the development process, Nanostim (St. Jude Medical) and Micra (Medtronic Inc.). To date, no leadless pacemakers are FDA approved, however both Nanostim and Micra have CE Marking and are currently undergoing late-stage trials.
Both Nanostim and Micra leadless pacemakers are single chamber, right ventricular pacing devices intended for roughly 15 percent of U.S. patients in need of pacing. St. Jude Medical is currently developing a dual-chamber version of the Nanostim.
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While the cost for both devices is not yet publicly available, the 2015 Medicare payment (national rate) to the hospital under the Outpatient Prospective Payment System is $14,846.
While clinical evidence is limited, optimism is high that leadless pacemakers can make a large impact on complication rates. The Nanostim is currently in the process of a U.S. pivotal trial and Micra is in phase 3 clinical trials. Early findings and published safety and efficacy objectives for both devices have been recently published.
Nanostim
- U.S. pivotal trial
- CE marking granted October 2013
- Estimated battery life of 8.4 years at 100 percent pacing, 12.4 years at 50 percent pacing
- Procedure time is approximately 30 minutes
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Nanostim Clinical Evidence
- Case series study of 33 patients (67 percent male)
- Mean age of 77 years
- Most common indication was permanent atrial fibrillation with atrioventricular block (65 percent)
- 31 of 33 participants (94 percent) were free from complications
- 3 patients (9 percent) required re-hospitalization within 90 days of implantation
- 5 patients (15 percent) required use of more than 1 device during the implantation procedure
- Average procedure time was 28 minutes (11-74 minutes)
- Average time to hospital discharge was 31 hours (17-113 hours)
- No pacemaker associated complications were reported at 90 day and 1 year follow up
Micra
- Phase III clinical trial
- CE marking granted April 2015
- Estimated battery life of 7 to 15 years
- Procedure time is less than 1 hour
Micra Clinical Evidence
- Safety and efficacy study of 140 patients
- Average procedure time was 37 minutes (11-154 minutes)
- No unanticipated serious adverse events were reported
- 30 adverse events (AEs) occurred in 26 patients
- Of the 30 AEs, 9 (6 percent) were dysrhythmias, 7 (5 percent) were events at device placement site and 10 (7 percent) were events at the groin puncture site
Whether or not leadless pacemakers become the new standard of care, the possibilities of these devices point to a bright future for innovations in cardiovascular disease treatment.
