PMA (premarket approval) supplement for CardioVascular Dynamics' coronary catheter:
This article was originally published in Clinica
CardioVascular Dynamics has received a premarket approval supplement for its Guardian coronary catheter, part of a range of catheters developed using the company's Focus technology. It allows most of the dilation force during a balloon angioplasty procedure to be focused more directly to the lesion site. The Guardian catheter is made from a softer, polyethylene-blend material which enhances movement of the guidewire. Its distal tip has been elongated to hug the guidewire, allowing the catheter to reach more distal parts of the anatomy. The company expects full marketing of the product in August.
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