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New Device Approval

FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty PTCA Catheter - P020037

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty PTCA Catheter
Manufacturer: X Technologies Inc.
Address: 15042 Parkway Loop, Suite A, Tustin, CA 92780
Approval Date: June 11, 2003
Approval Letter: http://www.fda.gov/cdrh/pdf2/p020037a.pdf

What is it and how does it work? The miniRail Catheter is a flexible tube containing an inflatable balloon and external stainless steel wires. It is used to open coronary artery blockages caused by the accumulation of plaque material in the artery wall. The inflatable balloon is attached to a segment of the tube near its end. This end is inserted into a small opening in a vein in the arm or the leg and gently advanced over a guide wire to the area of the blockage in the coronary artery. The balloon is inflated, pushing the wires into plaque. This causes the plaque to crack and break-up, thus reopening the coronary artery.

When is it used? In patients with one or more coronary artery blockages or narrowings. This catheter is particularly useful for treating coronary artery blockages that have returned some time after applying a coronary stent, as well as blockages that are expected to be resistant to balloon catheters that do not have the external wire.

How is it used? With the aid of fluoroscopic imaging, the physician:

• advances a guide wire to the target location -- the arterial blockage or narrowing,
• advances the balloon catheter over the guide wire to the target location,
• inflates the balloon to push the wires into the plaque.
• deflates and removes the balloon catheter and guide wire.

This procedure re-opens coronary arteries so blood flows more freely. The plaque fractures gently so that complications and restenosis can be minimized.

What will it accomplish? The increased blood flow through the coronary arteries should improve heart functions, decrease chest pain, and reduce the risk of heart attack, stroke and other events often experienced by patients with blocked or narrowed coronary arteries.

When should it not be used? In patients:

• whose blockage is in an unprotected left main coronary artery,
• whose normal coronary artery has a spasm

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf2/p020037.html

Others:
Reference:

• Coronary artery balloon angioplasty: http://www.nlm.nih.gov/medlineplus/ency/presentations/100160_1.htm
  

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