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benchmark bmx96 access system
Penumbra
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
510K
Number
K201271 ↗
Decision Date
June 11, 2020
Product Code
DQY
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.
Clinical Applications
Common clinical scenarios for the Benchmark BMX96 Access System include procedures requiring enhanced venous access, such as in patients with venous obstructions or those undergoing repeated venous interventions.
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.
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.