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Trireme Medical
Summary: The GliderXtreme PTA Balloon Catheter is used in percutaneous transluminal angioplasty (PTA) procedures to treat vascular stenosis. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K112281 ↗
Decision Date
August 17, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The GliderXtreme PTA Balloon Catheter was cleared through the FDA 510(k) pathway on August 17, 2011. It is manufactured by Trireme Medical and is classified as a Class 2 medical device.
What It Is
The GliderXtreme PTA Balloon Catheter is a medical device designed for use in percutaneous transluminal angioplasty procedures. It works by inflating a balloon within a narrowed blood vessel to widen it and restore normal blood flow. The device is compatible with 0.018-inch guide wires and is used over the wire, allowing for precise navigation and placement.
Clinical Applications
This device is commonly used in the treatment of peripheral vascular disease, particularly in cases of arterial stenosis. It is often employed in interventional radiology and vascular surgery settings. Patients who benefit from this device typically have conditions such as atherosclerosis or other forms of vascular narrowing that impede blood flow.
Indications for Use
The FDA indications suggest that the GliderXtreme PTA Balloon Catheter is intended for use in patients with vascular stenosis, where it can help to open up narrowed blood vessels. This is particularly relevant for patients with peripheral artery disease.
Practical Considerations
The GliderXtreme PTA Balloon Catheter is available in various sizes to accommodate different vessel diameters. It is important to select the appropriate size for the target vessel to ensure effective treatment. The device is designed for use with a 0.018-inch guide wire, which is a common size in vascular interventions.
Related Literature
The linked study involved a case of severe mesenteric ischemia in an 82-year-old woman with multiple vascular occlusions. The study demonstrated the use of balloon-expanding stents in conjunction with angioplasty to treat the condition. While the study provides insights into complex vascular interventions, its findings are limited by the single-case design and the specific patient profile.
Frequently Asked Questions
What is the GliderXtreme PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty to treat vascular stenosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with vascular stenosis to help open narrowed blood vessels.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.