This article was originally published in The Gray Sheet
Angioplasty/imaging catheter for use in percutaneous transluminal coronary angioplasty (PTCA) is approved by FDA Oct. 4. According to Endosonics, the Oracle-Micro is the "only device in the world that can perform both coronary balloon angioplasty and provide intravascular ultrasound imaging on the same catheter." The Pleasanton, California-based company will ship the Oracle-Micro "on a limited and well-controlled basis" during the "coming months" while it prepares PMA supplements for new versions of the device. Approval of Oracle-Micro comes three months after FDA made a request for additional clinical patient data on the device ("The Gray Sheet" July 11, In Brief)
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