InterVentional Technologies
This article was originally published in The Gray Sheet
Executive Summary
Firm enrolls first of 1,244 patients in a randomized controlled study comparing restenosis rates of its Barath surgical dilatation balloon catheter and conventional percutaneous transluminal coronary angioplasty. The cutting balloon "combines a conventional angioplasty balloon with microsurgical blades" that "incise the lesion ahead of the expanding balloon." Animal studies indicate that the combination will "facilitate maximal dilatation of the artery and lesion with the least amount of dilating force, which minimizes trauma to the artery." The investigational device exemption allows for 20 centers; 15 are expected to "come on line" by the middle of August
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