đź“Š Evidence-Based Reference
Device Modification to Pinnacle Destination Peripheral Guiding Sheath
Summary: The Pinnacle Destination Peripheral Guiding Sheath is a device used in embolization procedures. It is primarily utilized to facilitate the delivery of embolization coils. Key evidence includes FDA clearance and linked studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K080415 ↗
Decision Date ?
March 7, 2008
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Pinnacle Destination Peripheral Guiding Sheath was cleared by the FDA via the 510(k) pathway on March 7, 2008. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The Pinnacle Destination Peripheral Guiding Sheath is a medical device designed to assist in the delivery of embolization coils during interventional procedures. It provides a stable platform for catheter-based interventions in peripheral vasculature.
FDA-Cleared Indications
- Used to introduce and guide compatible interventional catheters and devices into the peripheral vasculature.
- Used to facilitate the delivery of embolization coils during peripheral vascular embolization procedures.
Clinical Applications
- Providing vascular access and support during peripheral artery embolization.
- Facilitating delivery of embolization coils to selected peripheral vessels.
- Supporting catheter-based treatment of aneurysms, pseudoaneurysms, or vascular bleeding in the peripheral circulation when compatible with the labeled device configuration.
Evidence Summary
The available literature includes five linked studies, though specific details on study types, total sample sizes, and date ranges are not provided. The studies are registered on ClinicalTrials.gov but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report limited specific efficacy findings for the Pinnacle Destination Peripheral Guiding Sheath. The linked studies do not provide detailed outcomes related to the device's performance or clinical efficacy.
Safety Profile
Reported complications include limited safety data from the linked studies. Specific adverse events or complications related to the use of the Pinnacle Destination Peripheral Guiding Sheath are not detailed in the provided evidence.
Evidence Limitations
The evidence base for the Pinnacle Destination Peripheral Guiding Sheath is limited by the lack of detailed outcomes and safety data in the linked studies. Further research is needed to better understand the device's clinical efficacy and safety profile.
Practical Considerations
- Available configurations may differ in sheath length, diameter, and tip design; the treating team selects a size compatible with the target vessel and the devices being delivered.
- The sheath is introduced through a vascular access site, commonly the femoral artery, and advanced under fluoroscopic imaging.
- Only compatible guidewires, catheters, coils, and other interventional devices should be used according to the manufacturer’s instructions.
- Potential complications include bleeding or hematoma at the access site, vessel injury, spasm, thrombosis, infection, contrast reaction, and embolic complications.
- MRI safety depends on the exact sheath configuration and whether the device remains in the body; the product labeling and institutional MRI screening policy should be checked before scanning.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Pinnacle Destination Peripheral Guiding Sheath?
The device is indicated for use in embolization procedures, particularly for facilitating the delivery of embolization coils in peripheral vasculature.
What outcomes have been reported in clinical studies?
Specific findings from the linked studies are not detailed, limiting the available information on clinical outcomes.
What complications have been reported?
Safety data from the linked studies is limited, with no specific complications detailed 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.