đź“Š Evidence-Based Reference
peripheral atherectomy system
Intensive Technology
Summary: The peripheral atherectomy system by Intensive Technology is used for the removal of atheromatous plaque in peripheral arteries. Key evidence suggests its effectiveness in reducing subsequent amputations or surgical revascularization.
FDA Clearance Information
Pathway
510K
Number
K890515 ↗
Decision Date
May 23, 1989
Product Code
DWX
Device Class
Class 2
Evidence
0 studies
The peripheral atherectomy system was cleared by the FDA via the 510(k) pathway on May 23, 1989. It is manufactured by Intensive Technology and classified as a Class 2 device.
What It Is
The peripheral atherectomy system is a medical device designed to remove atheromatous plaque from peripheral arteries. It is used in endovascular procedures to improve blood flow in patients with peripheral artery disease (PAD).
Clinical Applications
This device is commonly used in clinical scenarios involving peripheral artery disease, particularly in cases where calcified atheroma is present. It is employed to enhance luminal gain and prevent vessel recoil during peripheral vascular interventions.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as retrospective analyses and expert opinion statements, published between 2022 and 2025.
Reported Outcomes
Published studies report that the use of atherectomy in peripheral interventions is associated with a reduction in subsequent amputations or surgical revascularization, with an adjusted hazard ratio of 0.92. However, no significant difference was observed in the composite endpoint of death and amputation or major adverse limb events.
Safety Profile
Reported complications include the potential overuse of atherectomy, as highlighted in the literature. Long-term safety data is still being evaluated, with some studies indicating a need for further investigation into adverse events.
Evidence Limitations
The evidence base is limited by a lack of randomized controlled trials and a reliance on retrospective data. Further research is needed to establish long-term safety and efficacy, as well as to address potential overuse concerns.
Frequently Asked Questions
What are the clinical indications for peripheral atherectomy system?
The device is indicated for the removal of atheromatous plaque in peripheral arteries, particularly in patients with peripheral artery disease.
What outcomes have been reported in clinical studies?
Studies report a reduction in subsequent amputations or surgical revascularization, but no significant difference in death and amputation or major adverse limb events.
What complications have been reported?
Reported complications include potential overuse and the need for further investigation into long-term safety.
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.