đź“Š Evidence-Based Reference
Surmodics Surveil Drug-Coated Balloon
Product: SurVeil DCB — all models and sizes
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 Drug-Eluting Peripheral Transluminal Angioplasty Catheter
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.
FDA-Cleared Indications
- The FDA record identifies a change to the in-process specification criteria for the balloon base-coat solution.
- The device is a drug-eluting peripheral transluminal angioplasty catheter intended for percutaneous treatment of peripheral arterial stenosis.
Clinical Applications
- Drug-coated balloon angioplasty of stenotic lesions in the femoropopliteal arteries.
- Percutaneous treatment of peripheral arterial disease involving the superficial femoral or popliteal artery segments.
- Delivery of paclitaxel to the vessel wall during angioplasty to help reduce recurrent narrowing.
Reported off-label uses
- Use in peripheral arteries outside the labeled femoropopliteal treatment segment may occur in practice, but is off-label and depends on the specific device labeling and clinical judgment.
- Treatment of certain below-the-knee or other non-labeled peripheral lesions may be reported with drug-coated balloons, but should not be assumed to be an approved use of SurVeil.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The available FDA record describes a manufacturing specification change and does not provide a complete list of catheter diameters, lengths, lesion limits, or sheath requirements; consult the current manufacturer instructions for use.
- The balloon is used over a guidewire with fluoroscopic imaging. Lesion preparation, vessel sizing, inflation pressure, and inflation time should follow the device labeling and standard angioplasty technique.
- Paclitaxel allergy, hypersensitivity to device materials or excipients, significant untreated inflow disease, severe calcification, thrombosis, or inability to safely cross the lesion may affect suitability.
- MRI safety depends on the device components and whether the catheter remains in the patient; review the current labeling for MRI conditions. The temporary delivery catheter is generally removed after treatment.
- Drug-coated balloon treatment does not eliminate the possibility of restenosis, thrombosis, dissection, perforation, distal embolization, or the need for repeat endovascular treatment or surgery.
Procedures that use this 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.