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St. Jude Bolsters AF Offerings Through HIFU, ProRhythm Purchase Option

This article was originally published in The Gray Sheet

Executive Summary

St. Jude Medical could add a minimally invasive high-intensity focused ultrasound (HIFU) ablation therapy system to its fledgling atrial fibrillation unit under an agreement with developer ProRhythm

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ProRhythm pivotal approval

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...

ProRhythm pivotal approval

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...

St. Jude’s Epic Year Wins Over Investors; MDDI Index Up 15% In 2004

St. Jude Medical's entry into the cardiac resynchronization therapy ICD market and expanded atrial fibrillation business helped capture the attention of Wall Street and potential suitors in 2004 as its stock jumped 37% for the year

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