📊 Evidence-Based Reference
Pinnacle Precision Access System
Summary: The Pinnacle Precision Access System by Terumo Medical is a Class 2 medical device cleared by the FDA for use in embolization-coils procedures. It is supported by six studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111606 ↗
Decision Date ?
October 3, 2011
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Pinnacle Precision Access System was cleared through the FDA 510(k) pathway on October 3, 2011. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The Pinnacle Precision Access System is designed for precise vascular access in embolization procedures. It facilitates the delivery of embolization coils to target sites within the vasculature, aiding in the treatment of vascular abnormalities.
FDA-Cleared Indications
- Vascular access and delivery of embolization coils during embolization procedures.
- Use in procedures involving the placement of embolization coils within the vasculature.
Clinical Applications
- Access for embolization-coil treatment of selected aneurysms.
- Access for embolization-coil treatment of selected arteriovenous malformations.
- Catheter access and coil delivery during peripheral vascular embolization procedures.
- Catheter access and coil delivery during neurovascular embolization procedures when consistent with the device labeling.
Evidence Summary
The available literature includes six studies, though none directly pertain to the Pinnacle Precision Access System. The studies range from 2011 to 2025, covering various topics unrelated to the device's specific clinical applications.
Reported Outcomes
Published studies report no specific efficacy findings related to the Pinnacle Precision Access System, as the available evidence does not directly address its clinical performance or outcomes.
Safety Profile
Reported complications include no specific safety data related to the Pinnacle Precision Access System, as the available studies do not provide direct safety outcomes for this device.
Evidence Limitations
The current evidence lacks direct studies on the Pinnacle Precision Access System, highlighting a gap in specific clinical outcomes and safety data. Further research is needed to evaluate its efficacy and safety in embolization procedures.
Practical Considerations
- The access system must be matched to the intended guidewire, catheter, embolization coil system and vessel size.
- Use requires fluoroscopic or other appropriate imaging guidance by trained clinicians.
- The access site, vessel anatomy and need for anticoagulation or contrast should be assessed before the procedure.
- Potential complications of vascular access include bleeding, hematoma, infection, vessel injury, thrombosis and distal embolization.
- MRI safety depends on the specific components used and their labeling. Confirm the current manufacturer MRI instructions before scanning; do not assume the system is MRI safe or conditional.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Pinnacle Precision Access System?
The device is indicated for use in embolization-coils procedures, aiding in the precise delivery of coils to target vascular sites.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the available studies for the Pinnacle Precision Access System.
What complications have been reported?
No specific complications have been reported in the available studies for the Pinnacle Precision Access System.
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.