Aveir Leadless Pacemaker VR by Abbott Medical Receives Important Regulatory Approval
Abbott Medical's innovative product, the Aveir Leadless Pacemaker VR, has been granted approval by China's regulatory authorities in Feb 2024. This Class III medical device is designed for implantation in the right ventricle to provide pacing therapy for patients with severe bradycardia. It is suitable for patients with normal sinus rhythm experiencing occasional atrioventricular block or sinus arrest, chronic atrial fibrillation, and severe physical disabilities. The device also offers rate-adaptive pacing, beneficial for patients with chronotropic incompetence and those engaging in physical activities.
The Aveir Leadless Pacemaker VR, used in conjunction with a programmer, delivery, and retrieval catheter system, is capable of sensing intrinsic cardiac signals and providing pacing therapy to the targeted patient group. Notably, it is MRI safe under specific conditions, allowing patients to undergo MRI scans at 1.5T and 3.0T field strengths with appropriate precautions for the patient and the implanted device.
Extensive research, including four long-term animal studies using sheep, has been conducted to evaluate the device's functional safety (regarding displacement and perforation) and electrical performance (pacing and sensing) over 90 days. Additional assessments include a 24-day study on functionality and potential anatomical damage and a 210-day evaluation of the device's retrievability. Comprehensive post-mortem examinations, histology, and histopathology were performed to ensure product safety.
Furthermore, two acute design verification studies were carried out to assess the safety and usability of the Aveir Leadless Pacemaker system for implantation in the right ventricle.
Clinical evaluations were conducted in two phases. The first phase assessed the safety and efficacy of the predecessor, the Nanostim Leadless Pacemaker, in treating bradycardia using a VVI(R) pacing mode. This prospective, non-randomized, international multicenter, single-arm clinical trial involved 300 patients successfully implanted across 56 study centers worldwide. Key trial outcomes aimed for a greater than 86% probability of no device and/or surgery-related complications within six months post-implantation and over 85% of patients meeting the pacing threshold and R-wave amplitude criteria.
The Aveir VR device, featuring design, size, and performance enhancements over the Nanostim SR model, underwent a second phase of clinical trials to verify its safety and efficacy in treating bradycardia. This phase involved 196 patients across 43 global study centers. The primary safety endpoint was set at a greater than 86% probability of no device and/or surgery-related complications six weeks post-implantation, with the primary efficacy endpoint requiring over 85% of patients to meet the pacing threshold and R-wave amplitude criteria within the same period.
This approval marks a significant advancement in cardiac pacing technology, offering a new, safer, and more effective treatment option for patients with severe bradycardia.
For those interested in further information or involvement in clinical trials, especially regarding active implantable devices, TX Medical boasts extensive experience in this field.
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