AVIER LEADLESS PACEMAKER (IMPLANTABLE PACEMAKER PULSE GENERATOR): A REVIEW

Description

Abstract (English)

Patients suffering from arrhythmias, bradycardia or chronic atrial arrhythmia with high
degree blocks faced complications associated with transvenous pacemaker specially with old
techniques which involved subcutaneous pocket, bleeding, infection and even a
pneumothorax during surgical placement of pacemaker can be overcome by using leadless
pacemaker. In 2013, the first leadless pacemaker was introduced in international clinical trials
but removed from market due to its premature battery exhaustion. Then it redesigned with
key design improvements. The leadless ll phase 2 trial then approved by FDA (Food and
Drug Administration) on March 31st, 2022. In trials study included 200 subjects across 43
sites in different countries. Procedures were performed without endotracheal intubation. The
objective of this study was to evaluate the success of implantation, its performance and
preclinical studies. In phase ll implantation success was 98%. Unique aspects of this device
were improved implant success rate and low repositioning rates. The new design of leadless
pacemaker is with dual – helix fixation mechanism which is specific to right atrium anatomy.
The avier leadless pacemaker contains following components:
• The avier leadless pacemaker [LSP112V]
• Avier delivery system catheter [LSCD111]
• Avier link module [Model LSL02]
It is conditionally safe for use in MRI environment by following up proper instructions. The
avier leadless pacemaker met its all safety and efficacy end points. Patients who have poorly
integrated hardware such as drivelines, comorbidities associated with discomfort and
infection. Experts predicted that advancement in transcutaneous charging capabilities will
soon render large devices which may be completely implantable.