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Reekross Family or OTW PTA Catheters
Summary: The Reekross Family or OTW PTA Catheters by Clearstream Technologies are used for percutaneous transluminal angioplasty. Key evidence highlights their application in venous steno-occlusive lesions and limb ischemia.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083596 ↗
Decision Date ?
March 2, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Reekross Family or OTW PTA Catheters were cleared by the FDA via the 510(k) pathway on March 2, 2009. Manufactured by Clearstream Technologies, they are classified as Class 2 devices.
What It Is
The Reekross Family or OTW PTA Catheters are medical devices designed for percutaneous transluminal angioplasty (PTA). They are used to dilate narrowed or obstructed blood vessels, improving blood flow in patients with vascular conditions.
FDA-Cleared Indications
- Used for percutaneous transluminal angioplasty of stenotic or obstructed peripheral blood vessels.
- Intended to dilate vascular lesions and restore or improve blood flow.
- The device is identified under FDA product code DQY, Catheter, Percutaneous, under 21 CFR 870.1250.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Balloon dilation of selected venous stenoses or occlusions when clinically appropriate.
- Treatment of peripheral vascular lesions causing impaired blood flow.
- Use as an over-the-wire catheter during image-guided endovascular intervention.
Reported off-label uses
- Angioplasty of selected dialysis access stenoses, when the catheter's size, pressure rating and labeling are appropriate.
- Treatment of certain central venous or other complex venous lesions beyond the specific cleared labeling, based on clinician judgment and institutional practice.
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 three studies: one prospective randomized study and two retrospective studies, with publication years ranging from 2009 to 2022. These studies explore the efficacy and strategies of using PTA catheters in various clinical scenarios.
Reported Outcomes
Published studies report varying success rates for different strategies in managing venous steno-occlusive lesions, with technical success rates for SAP/OTW at 32.2% and clinical success rates for PTA at 43.2%. Infrapopliteal angioplasty with OTW balloons has been used in severe limb ischemia with noted clinical outcomes.
Safety Profile
Reported complications include the general risks associated with angioplasty procedures, such as vessel injury or restenosis. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small sample sizes and retrospective nature of some studies. Further research is needed to establish long-term outcomes and safety profiles for these devices.
Practical Considerations
- The catheter is advanced over a guidewire through a vascular access sheath, typically using fluoroscopic imaging.
- Available sizes, balloon diameters, shaft lengths, guidewire compatibility and rated burst pressures must be confirmed in the current manufacturer instructions for use.
- Use requires suitable vascular access and an appropriately sized guidewire, sheath and contrast-imaging system.
- Contraindications and precautions include inability to cross the lesion, severe vessel tortuosity, active infection at the access site, uncorrected bleeding risk and allergy to contrast or catheter materials.
- MRI safety depends on the exact catheter model and whether any component remains in the patient; consult the device labeling. A temporary catheter removed after the procedure generally does not create a continuing MRI issue.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Reekross Family or OTW PTA Catheters?
These catheters are indicated for use in percutaneous transluminal angioplasty to treat narrowed or obstructed blood vessels, particularly in venous steno-occlusive lesions and limb ischemia.
What outcomes have been reported in clinical studies?
Clinical studies have reported success rates for different strategies, with SAP/OTW achieving a technical success rate of 32.2% and PTA a clinical success rate of 43.2%.
What complications have been reported?
Reported complications include general risks associated with angioplasty, such as vessel injury or restenosis, though specific adverse events were not detailed in the studies.
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.