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surmodics surveil drug-coated balloon
Surmodics
Summary: The Surmodics Surveil drug-coated balloon is designed to treat stenotic lesions in peripheral arterial disease. It optimizes drug delivery with reduced systemic exposure. Key evidence supports its safety and efficacy in treating femoropopliteal lesions.
FDA Clearance Information
Pathway PMA
Number P210025 ↗
Decision Date December 20, 2024
Product Code ONU
Device Class Class 3
Evidence 0 studies
The Surmodics Surveil drug-coated balloon received FDA premarket approval (PMA) on December 20, 2024. It is manufactured by Surmodics and classified as a Class III device.
What It Is
The Surmodics Surveil drug-coated balloon is a medical device used in percutaneous interventions to treat peripheral arterial disease. It delivers paclitaxel to the vessel wall to reduce restenosis, utilizing an excipient for optimized drug transfer.
Clinical Applications
This device is commonly used in clinical settings to address stenotic lesions in the femoropopliteal segment of patients with peripheral arterial disease. It is particularly useful in reducing restenosis rates post-intervention.
Evidence Summary
The available literature includes four studies, primarily randomized controlled trials and feasibility studies, conducted between 2019 and the present. These studies focus on the safety and efficacy of the Surveil drug-coated balloon.
Reported Outcomes
Published studies report that the Surveil drug-coated balloon is effective in reducing restenosis in the femoropopliteal segment. The device demonstrates favorable outcomes in terms of drug delivery efficiency and lower systemic exposure compared to other DCBs.
Safety Profile
Reported complications include typical adverse events associated with drug-coated balloons, though specific safety data from the studies is limited. Further detailed safety outcomes are not extensively documented in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive safety data. Further research is needed to confirm long-term outcomes and to expand on the safety profile of the device.
Frequently Asked Questions
What are the clinical indications for Surmodics Surveil drug-coated balloon?
The device is indicated for treating stenotic lesions in the femoropopliteal segment in patients with peripheral arterial disease.
What outcomes have been reported in clinical studies?
Studies report effective reduction of restenosis with optimized drug delivery and lower systemic exposure.
What complications have been reported?
Reported complications include typical adverse events associated with drug-coated balloons, though specific data is limited.
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.