Aveir Leadless Pacing System – Aveir Leadless Pacemaker, Model LSP112V (Right Ventricular); Aveir Delivery Catheter, Model LSCD111; and Aveir Link Module, Module LSL02 – P150035
| Aveir™ Leadless Pacemaker | Aveir™ Delivery Catheter | Aveir™ Link Module |
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This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Aveir™ Leadless Pacemaker System
PMA Applicant: Abbott Medical
Address: 15900 Valley View Court, Sylmar, CA 91342
Approval Date: March 31, 2022
Approval Letter: Approval order
What is it?
The Aveir Leadless Pacemaker System is intended to correct slow (bradycardia) or irregular heart rhythms by generating electrical pulses that prompt the heart to beat at a normal rate. This system includes a leadless pacemaker, delivery catheter and link module.
How does it work?
The doctor makes a small cut (incision) in the patient’s leg (femoral vein) and uses a delivery catheter to implant the Aveir Leadless Pacemaker into the right ventricle of the heart. Once the pacemaker is implanted, the electrodes from the Aveir Link Module are placed on the patient’s skin. The doctor is then able to wirelessly connect to the leadless pacemaker using the link module and adjust the pacemaker’s settings based on the needs of the patient. The doctor is also able to collect information about how the pacemaker is working using the link module.
When is it used?
The Aveir Leadless Pacemaker is intended for use in patients with slow or irregular heart rhythms who may benefit from a pacemaker system that works in one chamber of the heart (single chamber pacemaker system). This system may also be used if a traditional pacing system with leads is hard to place.
What will it accomplish?
In the clinical trial with 526 patients, the Aveir Leadless Pacemaker System was shown to be safe and effective for single chamber pacing. During the second phase of the clinical trial which included 200 patients, data confirmed the safety and effectiveness of the device at 6 weeks post-implantation.
When should it not be used?
The Aveir Leadless Pacemaker should not be used in patients with:
- An implanted cardioverter/defibrillator (ICD) that detects life-threatening rapid heartbeats and sends an electrical shock to correct the rhythm
- An implanted filter to catch blood clots in one of the primary veins that carries blood to the heart (vena cava) or a mechanical valve between the heart’s right lower chamber (ventricle) and the right upper chamber (atrium), called the tricuspid valve
- A known history of allergies to any of the parts or components of this device
In addition, some features of the Aveir Leadless Pacemaker should not be used under certain conditions.
- Single-chamber ventricular demand pacing should not be used for most patients who have shown worsening symptoms after the pacemaker is implanted (pacemaker syndrome), a heart condition known as retrograde (ventriculo-atrial) conduction, or who experience a drop blood pressure in the arteries when pacing starts.
- Rate-responsive pacing should not be used for patients who are not able to tolerate high sensor-driven rates.