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reekross family or otw pta catheters
Clearstream Technologies
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
510K
Number
K083596 ↗
Decision Date
March 2, 2009
Product Code
DQY
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.
Clinical Applications
These catheters are commonly used in the management of venous steno-occlusive lesions and severe limb ischemia, particularly in diabetic patients. They provide a minimally invasive option for restoring vessel patency.
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.
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.