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Conquest PTA Balloon Dilatation Catheter
Summary: The Conquest PTA Balloon Dilatation Catheter is a medical device used primarily for dilating stenotic vessels. It is FDA 510(k) cleared and linked to studies examining radial force distribution and drug-eluting balloon angioplasty.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083657 ↗
Decision Date ?
December 24, 2008
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Conquest PTA Balloon Dilatation Catheter was cleared by the FDA via the 510(k) pathway on December 24, 2008. It is manufactured by C.R. Bard and classified as a Class 2 device under product code DQY.
What It Is
The Conquest PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic segments in blood vessels. It is used to restore vessel patency by applying radial force to the vessel walls.
FDA-Cleared Indications
- Dilatation of stenotic lesions in peripheral and central blood vessels during percutaneous transluminal angioplasty.
- Use with compatible guidewires and accessory devices during catheter-based vascular interventions.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Balloon dilation of stenosed central veins.
- Adjunctive dilation of venous stenosis during venous stent placement.
- Treatment of vessel narrowing to improve luminal patency during an endovascular procedure.
Reported off-label uses
- Dilation of stenosis within or adjacent to a previously placed venous stent when performed outside the device's specific labeling.
- Use in selected dialysis-access or other vascular lesions when the anatomy, balloon size, and labeling do not specifically cover the application.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes two studies: one experimental study from 2024 examining radial force distribution and another clinical trial on drug-eluting balloon angioplasty for dialysis access. The studies vary in design, including RCT and unknown types.
Reported Outcomes
Published studies report on the radial force exerted by balloon catheters, highlighting differences along the longitudinal axis. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential variations in radial force application, which may affect procedural outcomes. No specific adverse events are detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcome data. Further research is needed to establish comprehensive safety and efficacy profiles.
Practical Considerations
- The available balloon diameters, lengths, shaft configuration, and rated burst pressures depend on the specific catalog number; the current product labeling should be checked before use.
- The catheter must be compatible with the selected guidewire, introducer sheath, and vascular access route.
- Balloon inflation should follow the manufacturer's recommended contrast medium, inflation limits, and rated burst pressure; excessive inflation can cause vessel injury or balloon rupture.
- MRI safety depends on the exact device configuration and whether any components remain in the patient. Consult the current labeling and institutional MRI policy rather than assuming the catheter is MRI safe.
- Contraindications and precautions include inability to cross the lesion, severe vessel tortuosity, uncorrected bleeding risk, contrast allergy, infection at the access site, and anatomy unsuitable for balloon angioplasty.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Conquest PTA Balloon Dilatation Catheter?
The device is indicated for dilating stenotic segments in blood vessels, often used in conjunction with venous stents.
What outcomes have been reported in clinical studies?
Studies have focused on radial force distribution, but specific clinical outcomes are not detailed in the provided evidence.
What complications have been reported?
Safety data is limited, but variations in radial force application have been noted as a potential concern.
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.