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news.Stereotaxis, a developer of advanced cardiology instrument control systems, has announced that the commercial launch of its partnered magnetic irrigated catheter will begin next week at centers in Europe.
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This decision to release the magnetic irrigated catheter for commercial use was made following its strong performance in the partner’s recently concluded external evaluation.
During the external evaluation, clinicians at nine centers in Europe and Canada performed 92 procedures with the magnetic irrigated catheter, approximately 75% of which were complex left-sided procedures.
According to the company, the catheter exceeded all clinical end points tested during this evaluation period. Additionally, mean time to complete mapping and ablation was 20% below documented manual times, and the catheter demonstrated an exceptional safety profile.
Mike Kaminski, president and COO of Stereotaxis, said: “With these very positive results from the external evaluation and feedback from participating clinicians, we are very excited about the commercial release of the magnetic irrigated catheter in the EU.
“We are confident that the launch of the magnetic irrigated catheter in Europe will be followed by the US launch, which will result in a significant increase in Niobe utilization rates that will drive our future commercial momentum.”