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ProRhythm pivotal approval

This article was originally published in The Gray Sheet

Executive Summary

Enrollment in Ronkonkoma, N.Y. firm's high-intensity focused ultrasound (HIFU) ablation system pivotal trial, focusAF, will begin this quarter after FDA cleared the trial to proceed Jan. 4. The firm inked a distribution/R&D pact with St. Jude in January 2005, giving St. Jude the exclusive right to acquire ProRhythm for $125 mil. in cash through March 31, 2007 (1"The Gray Sheet" Jan. 10, 2005, p. 4). The HIFU catheter has received a CE Mark for AF treatment, and the firm anticipates PMA approval by early next year...
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