đź“Š Evidence-Based Reference
rotapro rotational atherectomy system
Boston Scientific
Summary: The Rotapro Rotational Atherectomy System is a device used for modifying calcified coronary lesions. It is primarily used in patients with severe coronary artery calcification. Key evidence highlights its feasibility and safety in lesion preparation.
FDA Clearance Information
Pathway
510K
Number
K220962 ↗
Decision Date
September 6, 2022
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Rotapro Rotational Atherectomy System was cleared by the FDA through the 510(k) pathway on September 6, 2022. It is manufactured by Boston Scientific and is classified as a Class 2 device.
What It Is
The Rotapro Rotational Atherectomy System is a medical device designed to modify calcified coronary lesions. It uses rotational motion to ablate calcified plaque, facilitating subsequent stent placement. It is intended for use in patients with significant coronary artery calcification.
Clinical Applications
The device is commonly used in interventional cardiology for patients with heavily calcified coronary arteries that are difficult to treat with conventional balloon angioplasty. It is particularly useful in preparing lesions for stenting in cases of severe calcification.
Evidence Summary
The available literature includes a mix of study types such as case reports, case series, and retrospective analyses, with a total of 5 studies published between 2020 and 2024. These studies evaluate the device's safety, feasibility, and clinical outcomes.
Reported Outcomes
Published studies report successful lesion preparation and treatment of calcified coronary artery occlusions using the Rotapro system. One case series noted successful patency in a right coronary artery occlusion without major complications. The Rotapro study highlighted its feasibility in treating severely calcified lesions.
Safety Profile
Reported complications include adverse events related to the use of rotational atherectomy systems, as analyzed in the MAUDE database. However, specific studies noted no significant adverse events during procedures, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited by the small number of studies and the predominance of case reports and series, which may not provide comprehensive safety and efficacy data. Further large-scale, randomized controlled trials are needed to validate these findings.
Frequently Asked Questions
What are the clinical indications for Rotapro Rotational Atherectomy System?
The device is indicated for the modification of calcified coronary lesions to facilitate stent placement in patients with severe coronary artery calcification.
What outcomes have been reported in clinical studies?
Studies report successful lesion preparation and treatment of calcified coronary artery occlusions, with favorable patency outcomes and feasibility in severely calcified lesions.
What complications have been reported?
Safety data from evidence indicate no significant adverse events during procedures, although the MAUDE database highlights potential adverse events associated with rotational atherectomy systems.
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.