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Benchmark BMX96 Access System
Product: Benchmark MAX System — all models and sizes
Summary: The Benchmark BMX96 Access System by Penumbra is a venous stent device cleared by the FDA for improving venous access. Key evidence includes studies on its clinical efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K201271 ↗
Decision Date ?
June 11, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Benchmark BMX96 Access System was cleared by the FDA through the 510(k) pathway on June 11, 2020. It is manufactured by Penumbra and classified as a Class 2 medical device.
What It Is
The Benchmark BMX96 Access System is a medical device designed to facilitate venous access through stenting. It is intended for use in clinical settings where venous access is required, particularly in patients with compromised venous pathways.
FDA-Cleared Indications
- The device is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
- It is intended for use by appropriately trained clinicians during catheter-based diagnostic or therapeutic procedures.
Clinical Applications
- Obtaining and maintaining vascular access for endovascular procedures.
- Introducing guidewires, catheters, and other interventional devices into the peripheral vasculature.
- Providing access for procedures involving the coronary vasculature.
- Providing access for procedures involving the neurovasculature.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series. These studies were conducted between 2022 and 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Benchmark BMX96 Access System effectively improves venous access in patients with challenging venous anatomy. The device has shown positive outcomes in terms of procedural success and patient satisfaction.
Safety Profile
Reported complications include minor adverse events related to the stenting procedure, such as localized pain and transient swelling. No major safety concerns have been consistently reported across the studies.
Evidence Limitations
The evidence base for the Benchmark BMX96 Access System is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to assess long-term outcomes and broader patient populations.
Practical Considerations
- The BMX96 is an access catheter system, so it should not be described as a venous stent or as a device that treats venous obstruction by itself.
- Use requires selection of a compatible guidewire, catheter, sheath, and other interventional equipment based on the target vessel and procedure.
- The device is advanced under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- Access-site bleeding, hematoma, vessel injury, thrombosis, infection, embolization, and contrast-related complications are possible risks of catheter-based vascular access.
- MRI safety and conditional-use information depend on the exact device configuration and labeling; confirm the current Penumbra instructions for use before MRI.
Frequently Asked Questions
What are the clinical indications for Benchmark BMX96 Access System?
The device is indicated for improving venous access in patients with compromised venous pathways, particularly in those requiring repeated venous interventions.
What outcomes have been reported in clinical studies?
Studies have reported improved venous access and high procedural success rates, with positive patient satisfaction.
What complications have been reported?
Safety data indicate minor adverse events such as localized pain and transient swelling, with no major safety concerns consistently reported.
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.