Heart Technology
This article was originally published in The Gray Sheet
Executive Summary
Is beginning clinical trials of its Percutaneous Rotational Thrombectomy (PRT) device in the first quarter of this year under an investigational device exemption approved "at the end of last year," President Alan Levy announced at the Piper Jaffray investment conference. The device incorporates a flexible wire that is rotated at 5,000 revolutions per minute to treat arterial blood clots. The exec also reported that Heart Technology has received approval from FDA to resume clinical trials of its Rotablator atherectomy device for coronary applications and sales of the product for peripheral applications. The firm discontinued distribution of the device following a June recall and subsequently revised its manufacturing procedures in November to address the problem that led to the recall ("The Gray Sheet" Nov. 23, I&W-5).