Stereotaxis has won European CE mark approval for its MaGiC ablation catheter, a robotically navigated device for the treatment of heart arrhythmia.
Shares in the US company, which specialises in robotic magnetic navigation systems, opened 5.1% higher compared with a pre-announcement market close. MarketWatch has an average recommendation rating of ‘buy’ for the stock.
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MaGiC is a magnetic ablation catheter designed to perform minimally invasive cardiac procedures that treat heart arrhythmia. The approval in Europe includes the delivery of local lesions in cardiac tissue for the treatment of cardiac arrhythmias.
Ablation works as part of an approach called cardiac remapping by blocking pathways that conduct faulty electrical signals responsible for an irregular heartbeat. Magnetic ablation works via the interaction of small magnets in the catheter’s tip with a wider magnetic field generated by large magnets either side of the patient.
Stereotaxis claims its device offers enhanced stability, tissue contact information and low-flow uniform cooling. The catheter’s features are designed to enhance treatment precision and control. The company developed MaGiC based on insights from more than 150,000 robotic ablation procedures of predecessor models.
Stereotaxis initiated the first-in-human procedures with the technology in early 2024. The company reported positive results from the first 20 participants, with published results demonstrating 100% acute efficacy and no adverse events.
Stereotaxis’ CEO David Fischel said: “We look forward to seeing MAGiC serve as one of the key pillars in our effort to make robotics broadly impactful and beneficial in electrophysiology and endovascular surgery.”
The catheter may also be joining the US market this year as Stereotaxis also submitted a premarket application to the US Food and Drug Administration in March last year.
In third-quarter 2024 results, Stereotaxis reported an 18% year-over-year increase compared with the same period in 2023. The company stated the growth was in part due to orders of its main navigation platform Genesis. GenesisX, what the company calls its most accessible robotic system, received EU approval in August 2023.
In early 2024, Stereotaxis acquired privately held electrophysiology company Access Point Technologies (APT) for an undisclosed amount. At the time, Stereotaxis estimated that APT would contribute around $5m in annual revenue.
Whilst ablation generally has become a key treatment for heart conditions, pulsed field ablation (PFA) is the modality performing best in terms of market opportunity. Big medtech players such as Medtronic and Boston Scientific have launched PFA devices on the market and the uptake of the technology has been swift.
