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St. Jude Tendril SDX

This article was originally published in The Gray Sheet

Executive Summary

Steroid-eluting active fixation pacing lead gains FDA market go-ahead March 20. With a 6.2 Fr diameter, the lead will permit a less traumatic insertion procedure with the use of a 7 Fr. introducer sheath and allow for optimal placement with an "electrically active collar," which allows the physician to map the inside of the heart prior to placement, St. Jude says. Separately, the St. Paul, Minnesota firm announced March 21 receipt of a CE mark for its Photon DR dual-chamber implantable cardioverter defibrillator and completion of patient enrollment for U.S. clinical studies. The 12.7 mm wide, 46 cc device is "the world's thinnest dual-chamber ICD," St. Jude claims. A premarket approval application submission is anticipated in "mid-2000," St. Jude says. The European launch is slated for the second quarter

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