My cardiologist's staff has contacted me about having a leadless pacemaker after getting some results on November 20 from the heart monitor loop which is showing bradycardia, tachycardia and atrial fibrillation. In fact, several times it had stopped. So I thought I'd better be informed before I agreed to it since a few weeks ago I was told I was not going to have a pacemaker. There is not a lot of information.
"Traditional pacemakers have been the standard treatment option for patients with severe/symptomatic bradycardia, an arrhythmia indicating an unusually slow heart rate. While there have been significant advancements in pacemaker technology since its introduction in 1958, pacemaker devices have continued to require the creation of a surgical pocket under the skin on the upper portion of the chest wall in order to hold the power source, and the use of leads to reach the pacing site. Current leadless pacemaker devices are self-contained enclosed capsules that include the pacemaker electronics and battery, and are delivered via catheter to the right ventricle of the heart. Leadless pacemakers function similarly to traditional single-chamber ventricular pacemakers without requiring transvenous leads or the need for a surgical pocket. https://www.cms.gov/medicare/coverage/evidence/leadless-pacemakers
I wanted to know the background of the funding and approval. This was CHAT generated
"Based on the provided search results, here is a summary of the Aveir leadless pacemaker grants:
Indications: The system is indicated for management of one or more of the following permanent conditions: syncope, pre-syncope, fatigue, disorientation. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.
Retrievability: The Aveir leadless pacemaker has a high retrieval success rate, with a study demonstrating a rate of 88% over 9 years, making it a viable option for patients who may require future upgrades or removal.
Dual-Chamber Pacing: The Aveir DR system is the first dual-chamber leadless pacemaker approved by the FDA, allowing for simultaneous pacing of both the atrium and ventricle.
Battery Longevity: The Aveir VR leadless pacemaker has a projected battery longevity of up to 16 years, compared to the average 8-10 years for traditional transvenous pacemakers.
Clinical Trials: The LEADLESS II trial demonstrated the safety and effectiveness of the Aveir VR leadless pacemaker at 6 weeks post-implantation, with a high efficacy rate of over 98%.
Congenital Heart Disease: A retrospective review of three Aveir retrievable leadless pacemaker implants in adult patients with congenital heart disease showed successful implantation and short-term outcomes up to one year post-implant.
These grants and approvals demonstrate the Aveir leadless pacemaker’s potential as a safe and effective treatment option for patients with bradycardia or irregular heart rhythms, particularly those with congenital heart disease.
fda.gov
Aveir Leadless Pacing System – Aveir Leadless Pacemaker, Model LSP112V (Right Ventricular); Aveir Delivery Catheter, Model LSCD111; and Aveir Link Module, Module LSL02 – P150035 | FDA
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