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Benelli Access Device
Summary: The Benelli Access Device is a venous stent used primarily in vascular interventions. Key evidence highlights its role in facilitating transcatheter procedures with a focus on preprocedural imaging.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111334 ↗
Decision Date ?
August 1, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Benelli Access Device was cleared by the FDA through the 510(k) pathway on August 1, 2011. It is manufactured by Vascular Solutions and classified as a Class 2 device.
What It Is
The Benelli Access Device is a medical device designed for use in venous stenting procedures. It aids in maintaining vessel patency and is intended for use in patients requiring vascular interventions.
FDA-Cleared Indications
- Use as a percutaneous catheter for vascular access or catheter-based intervention, consistent with the FDA product classification.
- The provided record does not include specific FDA indications describing a stent, thrombectomy system, or treatment of a particular venous obstruction.
Clinical Applications
- Percutaneous catheter-based vascular procedures when the device is used according to its FDA-cleared labeling.
- Transcatheter vascular intervention requiring catheter access under imaging guidance.
Evidence Summary
The available literature includes four studies, primarily focusing on the role of imaging in transcatheter procedures. These studies span from 1990 to 2022 and include various study types such as retrospective and case series.
Reported Outcomes
Published studies report that the Benelli Access Device is effective in facilitating transcatheter procedures, particularly by enhancing preprocedural imaging. The device has been associated with improved procedural planning and outcomes in vascular interventions.
Safety Profile
Reported complications include typical risks associated with venous stenting, such as thrombosis and device migration. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically evaluating the Benelli Access Device. Further research is needed to establish long-term outcomes and safety profiles.
Practical Considerations
- The supplied FDA summary does not provide catheter length, French sizes, working-channel dimensions, guidewire compatibility, or other technical specifications.
- Use only with compatible equipment and according to the manufacturer's instructions for use; compatibility should be confirmed before the procedure.
- MRI safety information is not provided in the available record. Do not assume the device is MR Safe or MR Conditional without reviewing current labeling.
- Potential catheter-procedure risks include bleeding, infection, vascular injury, thrombosis, embolization, contrast reaction, and the need for additional intervention.
- Contraindications and precautions should be taken from the current manufacturer labeling and assessed against the patient's anatomy, bleeding risk, allergies, and planned procedure.
Frequently Asked Questions
What are the clinical indications for Benelli Access Device?
The device is indicated for use in venous stenting procedures, particularly in vascular interventions requiring vessel patency.
What outcomes have been reported in clinical studies?
Studies report improved procedural planning and outcomes in transcatheter interventions facilitated by enhanced preprocedural imaging.
What complications have been reported?
Safety data indicates risks such as thrombosis and device migration, though specific details are limited in the provided evidence.
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.