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turbo-elite atherectomy catheters turbo tandem system
Spectranetics
Summary: The Turbo-Elite Atherectomy Catheters by Spectranetics are used for atherectomy procedures. Cleared by the FDA via the 510k pathway, they are primarily used to treat peripheral arterial disease. Key evidence includes studies on laser and balloon angioplasty.
FDA Clearance Information
Pathway
510K
Number
K140775 ↗
Decision Date
July 23, 2014
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Turbo-Elite Atherectomy Catheters were cleared by the FDA through the 510k pathway on July 23, 2014. Manufactured by Spectranetics, they are classified as Class 2 medical devices under product code MCW.
What It Is
The Turbo-Elite Atherectomy Catheters are designed for atherectomy, a minimally invasive procedure to remove plaque from blood vessels. They utilize laser technology to ablate atherosclerotic lesions, facilitating improved blood flow in peripheral arteries.
Clinical Applications
These catheters are commonly used in the treatment of peripheral arterial disease, particularly in cases of in-stent restenosis. They are employed in both standalone procedures and in conjunction with other interventions like balloon angioplasty.
Evidence Summary
The available literature includes two clinical studies registered on ClinicalTrials.gov. These studies focus on the use of laser and balloon angioplasty in treating peripheral in-stent restenosis. The studies do not specify the total number of participants or the exact date range.
Reported Outcomes
Published studies report the use of the Turbo-Elite Atherectomy Catheters in conjunction with balloon angioplasty to effectively treat peripheral in-stent restenosis. The studies suggest potential benefits in reducing restenosis rates, although specific efficacy metrics are not detailed.
Safety Profile
Reported complications include typical procedural risks associated with atherectomy, such as vessel perforation and embolization. However, the studies provided do not offer detailed safety data or incidence rates of these complications.
Evidence Limitations
The evidence is limited by the lack of detailed study outcomes and safety data. Further research is needed to quantify efficacy and safety metrics, as well as to explore long-term outcomes and comparative effectiveness against other treatment modalities.
Frequently Asked Questions
What are the clinical indications for Turbo-Elite Atherectomy Catheters?
The device is indicated for use in atherectomy procedures to treat peripheral arterial disease, particularly in cases of in-stent restenosis.
What outcomes have been reported in clinical studies?
Studies suggest the device is effective in reducing restenosis rates when used with balloon angioplasty, though specific metrics are not detailed.
What complications have been reported?
Reported complications include vessel perforation and embolization, typical of atherectomy procedures, though detailed safety data is lacking.
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.