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spectranetics turbo-tandem system
Spectranetics
Summary: The Spectranetics Turbo-Tandem System is a device used for atherectomy in venous stents. It was FDA-cleared via the 510(k) pathway. Key evidence includes 13 studies examining its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K091299 ↗
Decision Date
July 1, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spectranetics Turbo-Tandem System was cleared by the FDA on July 1, 2009, under the 510(k) pathway. It is manufactured by Spectranetics and classified as a Class 2 device.
What It Is
The Spectranetics Turbo-Tandem System is an atherectomy device designed for the removal of atherosclerotic plaque from venous stents. It utilizes a laser mechanism to precisely target and ablate plaque, improving blood flow.
Clinical Applications
Commonly used in the treatment of peripheral artery disease, the Turbo-Tandem System is employed in scenarios where venous stents are occluded by plaque. It is particularly useful in cases requiring minimally invasive intervention.
Evidence Summary
The literature includes 13 studies, encompassing various study types such as RCTs and case series, published between 2022 and 2025. These studies provide insights into the device's clinical efficacy and safety profile.
Reported Outcomes
Published studies report that the Turbo-Tandem System effectively reduces plaque burden in venous stents, leading to improved vessel patency. Clinical trials have demonstrated its efficacy in enhancing blood flow and reducing symptoms associated with peripheral artery disease.
Safety Profile
Reported complications include minor procedural bleeding and transient vessel spasm. Overall, the device is considered safe with a low incidence of serious adverse events.
Evidence Limitations
Current evidence is limited by small sample sizes and short follow-up durations. Further research is needed to establish long-term outcomes and to compare its efficacy with alternative treatment modalities.
Frequently Asked Questions
What are the clinical indications for the Spectranetics Turbo-Tandem System?
The device is indicated for the removal of atherosclerotic plaque in venous stents, particularly in patients with peripheral artery disease.
What outcomes have been reported in clinical studies?
Studies have shown improved vessel patency and blood flow, with a reduction in symptoms related to peripheral artery disease.
What complications have been reported?
Safety data indicate minor procedural bleeding and transient vessel spasm as potential complications, with a low incidence of serious adverse events.
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.