This article was originally published in The Gray Sheet
Radii steerable, diagnostic catheter will begin shipping "within the current calendar quarter" following FDA clearance for the device the week of Dec. 28. For use in performing single-point mapping procedures in patients with certain types of abnormally rapid heart rhythms, predominantly supraventricular tachycardia, the catheter can locate "potential arrhythmia sites prior to therapeutic treatment," the Sunnyvale, California-based firm says. Five direct reps will market the device, for which a 510(k) was submitted to FDA in October
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