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rotablator rotational atherectomy system with peripheral rotalink plus
Boston Scientific
Summary: The Rotablator Rotational Atherectomy System by Boston Scientific is used for treating calcified arterial lesions. Key evidence highlights its role in lesion preparation before stent implantation, with studies focusing on procedural outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K121774 ↗
Decision Date
September 13, 2012
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 September 13, 2012. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The Rotablator Rotational Atherectomy System is a device designed to ablate calcified plaque in arterial lesions using a high-speed rotating burr. It is primarily used in percutaneous coronary interventions to facilitate stent placement in calcified arteries.
Clinical Applications
This device is commonly used in scenarios involving severely calcified coronary or peripheral arterial lesions where traditional balloon angioplasty or stenting may be insufficient. It aids in lesion preparation to improve stent expansion and reduce procedural complications.
Evidence Summary
The literature includes 14 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, published between 2023 and 2025. These studies evaluate the device's efficacy and safety in treating calcified lesions.
Reported Outcomes
Published studies report that the Rotablator system effectively prepares calcified lesions for stenting, improving stent expansion and reducing procedural complexity. Outcomes include enhanced lesion modification and reduced rates of stent underexpansion. However, the impact on long-term clinical outcomes remains under investigation.
Safety Profile
Reported complications include distal embolization and procedural complications associated with severe calcification. The device is generally considered safe when used by experienced operators, but careful patient selection is advised to minimize risks.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to establish long-term clinical benefits and to compare the device's efficacy with alternative atherectomy technologies.
Frequently Asked Questions
What are the clinical indications for the Rotablator Rotational Atherectomy System?
The device is indicated for use in patients with severely calcified coronary or peripheral arterial lesions to facilitate stent placement.
What outcomes have been reported in clinical studies?
Studies report improved stent expansion and reduced procedural complexity in calcified lesions, though long-term outcomes are still being evaluated.
What complications have been reported?
Safety data indicate risks of distal embolization and procedural complications, particularly in severely calcified lesions.
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.