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Highlights
- Imricor Medical Systems (ASX:IMR) submitted its second premarket approval module to the US FDA, focusing on manufacturing processes.
- The company is preparing the third PMA module and 510(k) application for its NorthStar system, anticipating a US commercial launch in early Q3.
- IMR is pioneering MRI-guided cardiac ablations to enhance arrhythmia treatment, aiming for US approval by 2025.
Imricor Medical Systems, known as the innovator behind MRI-compatible devices for cardiac ablations, took a significant step by submitting the second premarket approval (PMA) module to the US Food and Drug Administration (FDA). This module pertains to seven products, including six internal devices and an additional third-party product for distribution. The submission emphasizes Imricor’s focus on quality manufacturing, which includes various aspects such as design controls, raw material management, and process validation.
Streamlined Regulatory Pathway
To expedite the approval process, Imricor is adopting a modular review strategy with the FDA. This approach allows for sequential submission and evaluation of different product aspects. Currently, efforts are directed towards completing the third PMA module and the 510(k) application for the NorthStar 3D mapping and guidance system. The 510(k) pathway promises a quicker review cycle, facilitating an anticipated US market entry for NorthStar by early Q3. Following a recent CE Mark submission, the European launch is expected mid-year.
Advancement in Arrhythmia Treatments
Imricor's cutting-edge MRI-guided ablation technology aims to revolutionize cardiac ablation procedures, which target and remove heart cells causing arrhythmias. Unlike traditional methods that rely on X-ray fluoroscopy—offering limited efficacy for soft tissues—MRI guidance provides superior imaging for more effective treatments. This technology reduces radiation exposure for both patients and staff and enhances procedural success rates.
Pivotal Clinical Trials and Strategic Progress
With its Vision-MR Ablation of Atrial Flutter (VISABL-AFL) trial underway, Imricor is progressing towards US FDA approval, targeting 2025. The upcoming pivotal VISABL-VT trial in Europe will further support the company’s approval efforts for ventricular tachycardia (VT). Achieving timely module submissions, as acknowledged by Chair and CEO Steve Wedan, underscores the team’s dedication to bringing these advanced technologies to the US market.
The submission of the remaining PMA modules remains on schedule as Imricor continues its collaboration with the FDA. Ongoing updates on regulatory advances are anticipated, reinforcing Imricor’s commitment to transforming arrhythmia treatment with its innovative MRI-compatible devices.
