Abbott has announced that its Aveir dual-chamber leadless pacemaker has been implanted in the first patient under its AVEIR DR i2i clinical trial.
According to the company, this is the first implant to occur in the world within the pivotal trial.
The investigational Aveir DR dual-chamber pacemaker is intended to offer beat-by-beat, synchronous pacing of the heart’s right ventricle and right atrium.
The company’s implant-to-implant (i2i) device technology is being leveraged for providing communication between two leadless pacemakers for regulating the heartbeat.
This technology is aimed at synchronising the heart rate between chambers and enabling dual-chamber leadless pacing.
The multicentre, single-arm, prospective, international, pivotal investigational Aveir DR i2i study will assess Aveir DR leadless pacemaker’s clinical safety and efficacy in patients indicated for a DDD(R) or dual-chamber bradycardia pacing pacemaker.
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Taking place at up to 80 sites in Europe, Canada, the Asia-Pacific and the US, the pivotal study plans to recruit up to 550 subjects.
The company stated that the first implant was performed at Na Homolce Hospital in Prague, Czech Republic.
The Aveir DR leadless implants are designed to be retrievable, allowing surgeons to replace the device or retrieve it if a patient’s therapy needs change.
The system also provides real-time heart mapping, enabling surgeons to assess treatment delivery and reposition the device during the implanting procedure.
Abbott cardiac rhythm management business senior vice-president Randel Woodgrift said: “The Aveir DR dual-chamber leadless pacemaker builds upon our Aveir VR single-chamber leadless platform, and we believe that once approved these systems have the potential to change the way doctors approach the treatment of abnormal heart rhythms.
“The involvement of world-class heart institutions in this study reinforces that the innovations we are developing are exactly the kind of advancements physicians around the world want for their patients.”
Recently, Abbott reported worldwide sales of $11.5bn for the fourth quarter of 2021, representing a 7.2% growth on a reported basis.