Between December 2013 and October 2016, 1,423 of AVEIR™ VR Leadless Pacemaker’s (LP) predicate devices were implanted worldwide. Data was collected for each retrieval attempt and retrieval success was as follows:
Significantly, there were 241 retrieval attempts with an overall 88% success rate up to 9 years from implant to successful retrieval, as well as a 92.5% retrieval success rate in patients with 5 or more years from implant to successful retrieval. Also important to note, retrieval success rates remained high, regardless of implant duration or operator experience:
Part of the retrieval success is due to the simplicity of the retrieval process itself. The helix fixation allows the operator to unscrew the device from tissue, and as the data above indicated, a first-time operator is actually more successful than those who have more experience.
The 29 retrievals that were unsuccessful were due to the inability to reach the device. However, the design and placement have since been revised. The LP device has been redesigned with a fixed-post docking button and the retrieval catheter now has a tri-loop snare versus its original single-loop.
Overall, the data points from this study demonstrate that AVEIR VR LP's predicate device with helix fixation has a high and stable chronic retrieval success rate, accompanied by a low procedural complication rate. Safe, successful retrieval can be performed through at least 9 years post-implant.
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MAT-2303382 v1.0 | Item is approved for US use only