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Stellarex 0 035 OTW Drug-Coated Angioplasty Ballon
Product: Stellarex — all models and sizes
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 Drug-Eluting Peripheral Transluminal Angioplasty Catheter
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.
FDA-Cleared Indications
- The FDA record for PMA P160049 documents approval for updates to the device labeling.
- The device is a drug-eluting peripheral transluminal angioplasty catheter regulated under product code ONU.
Clinical Applications
- Peripheral transluminal angioplasty of diseased peripheral arteries.
- Treatment of symptomatic peripheral artery disease requiring endovascular revascularization.
- Balloon angioplasty of lesions in the femoropopliteal arterial segment.
- Drug delivery to the vessel wall during balloon inflation to help reduce restenosis risk.
Practical Considerations
- The balloon must be selected to match the target vessel diameter and lesion length; available sizes depend on the specific product configuration.
- It is an over-the-wire catheter used with guidewire-based angioplasty techniques and fluoroscopic imaging.
- Appropriate lesion preparation, balloon positioning and inflation technique are important for vessel injury control and drug transfer.
- MRI safety and scanning conditions should be confirmed in the current manufacturer labeling; do not assume MRI compatibility from the device name alone.
- Contraindications, warnings, drug-related precautions and restrictions on use in specific vessel locations should be checked in the current instructions for use.
Procedures that use this device
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.