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stellarex 0 035 otw drug-coated angioplasty ballon
The Spectranetics
Summary: The Stellarex 0.035 OTW Drug-Coated Balloon is a medical device used in angioplasty procedures to treat peripheral artery disease. It is primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway PMA
Number P160049 ↗
Decision Date September 13, 2019
Product Code ONU
Device Class Class 3
Evidence 0 studies
The Stellarex 0.035 OTW Drug-Coated Balloon received FDA clearance under PMA P160049 on September 13, 2019. It is manufactured by The Spectranetics and classified as a Class III device.
What It Is
The Stellarex 0.035 OTW Drug-Coated Balloon is a catheter-based device designed for percutaneous transluminal angioplasty (PTA) procedures. It is coated with a drug that helps prevent restenosis by inhibiting cell proliferation. The balloon is inflated at the site of a vascular lesion to open narrowed or blocked arteries, delivering the drug directly to the vessel wall.
Clinical Applications
This device is commonly used in the treatment of peripheral artery disease (PAD), particularly in the femoropopliteal arteries. It is utilized in both hospital and outpatient settings by interventional cardiologists and vascular surgeons. The Stellarex balloon is suitable for patients with symptomatic PAD who require revascularization to improve blood flow and reduce symptoms such as claudication.
Indications for Use
The Stellarex 0.035 OTW Drug-Coated Balloon is indicated for use in patients with peripheral artery disease to restore blood flow in narrowed or blocked peripheral arteries. It is particularly effective in treating lesions in the femoropopliteal segment.
Practical Considerations
The Stellarex balloon is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard angioplasty equipment and techniques. Proper sizing and inflation technique are crucial for optimal drug delivery and vessel patency.
Frequently Asked Questions
What is Stellarex 0.035 OTW Drug-Coated Balloon used for?
It is used for percutaneous transluminal angioplasty to treat peripheral artery disease by opening narrowed or blocked arteries and delivering a drug to prevent restenosis.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in the treatment of peripheral artery disease.
What are the FDA-cleared indications?
The device is indicated for use in patients with peripheral artery disease to restore blood flow in narrowed or blocked peripheral arteries, particularly in the femoropopliteal segment.
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.