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rotablator rotational atherectomy system with the peripheral rotalink plus
Boston Scientific
Summary: The Rotablator Rotational Atherectomy System is a device used for atherectomy in calcified lesions. It is primarily used to improve stent expansion in severely calcified coronary and peripheral arteries. Key evidence highlights its role in lesion preparation and potential reduction in procedural complications.
FDA Clearance Information
Pathway
510K
Number
K133566 ↗
Decision Date
December 20, 2013
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Rotablator Rotational Atherectomy System was cleared by the FDA via the 510(k) pathway on December 20, 2013. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The Rotablator Rotational Atherectomy System is a medical device designed to ablate calcified plaque in coronary and peripheral arteries. It uses a high-speed rotating burr to modify calcified lesions, facilitating subsequent stent placement and expansion.
Clinical Applications
This device is commonly used in interventional cardiology and peripheral vascular interventions to treat severely calcified lesions that impede stent deployment. It is particularly useful in cases where traditional balloon angioplasty is insufficient.
Evidence Summary
The literature includes 14 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2023 and 2025. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the Rotablator Rotational Atherectomy System effectively prepares calcified lesions, improving stent expansion and reducing procedural complexity. It has shown promise in reducing the rates of stent under-expansion and associated complications in severely calcified coronary lesions.
Safety Profile
Reported complications include potential distal embolization and procedural complications related to the rotational mechanism. However, the device is generally considered safe when used by experienced operators in appropriate clinical scenarios.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized trials directly comparing the Rotablator with other atherectomy devices. Further research is needed to establish long-term outcomes and optimal patient selection criteria.
Frequently Asked Questions
What are the clinical indications for Rotablator Rotational Atherectomy System?
The device is indicated for the treatment of severely calcified coronary and peripheral artery lesions to facilitate stent placement and expansion.
What outcomes have been reported in clinical studies?
Studies have reported improved stent expansion and reduced procedural complexity in treating calcified lesions, with a potential reduction in stent under-expansion.
What complications have been reported?
Safety data indicate potential complications such as distal embolization and procedural issues related to the rotational mechanism, though these are generally manageable.
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.