The FIRE STAR Rx PTCA Dilatation Catheter and the DURA STAR Rx PTCA Dilatation Catheter are indicated for expansion in the narrowed area of a coronary artery or bypass graft. The FIRE STAR Balloon features the lowest pre-dilatation profile in the market. It is equipped to enable interventional cardiologists to guide the catheter through tortuous arteries and to cross complex blockages, usually prior to the placement of a stent.
The DURA STAR Balloon facilitates the post-delivery expansion of stents in coronary arteries and is also suitable for tackling tortuous arteries and complex blockages. It has been designed to provide interventional cardiologists with controlled and even expansion of the balloon to the correct diameter, which may help reduce the potential for artery damage to the patient.
With its reportedly low pre-dilatation profile, the FIRE STAR Balloon is also designed for use in highly stenosed lesions and bifurcations. In addition, the FIRE STAR Balloon offers a controlled expansion for dilatation of arteries, which may help reduce the potential for artery damage. It also has a soft and tapered tip to facilitate crossing stent struts and challenging lesions, while its shaft construction helps to reduce the risk of kinking. The device is finished with a lubricating coating and is available in various lengths and diameters ranging from 10 mm to 30 mm and from 1.5 mm to 3.5 mm, respectively.
The DURA STAR Balloon is suited for use with both drug-eluting and bare-metal balloon-expandable stents. Its short and soft tip facilitates crossing stent struts and complex lesions. Equipped with a lubricating coating is intended to ease delivery to the site of a lesion. The balloon is available in various lengths from 10 to 30 mm and from 2.25 to 4.0 mm in diameter.
The U.S. Food and Drug Administration approved the commercialization of these products in late August.
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