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Envoy Distal Access Da Guiding Catheter 6f 95cm 105cm Straight Xb Mpd Xb Mpc Xb
Codman & Shurtleff
Summary: The Envoy Distal Access DA Guiding Catheter is used primarily for endovascular procedures involving cerebral aneurysms. Key evidence highlights its supportability and navigability in anterior circulation aneurysms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140080 ↗
Decision Date ?
April 24, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Envoy Distal Access DA Guiding Catheter was cleared via the FDA 510(k) pathway on April 24, 2014. It is manufactured by Codman & Shurtleff and classified as a Class 2 device.
What It Is
The Envoy Distal Access DA Guiding Catheter is a medical device designed to facilitate endovascular procedures by providing distal access and support for working devices. It is intended for use in neurovascular interventions, particularly in the treatment of cerebral aneurysms.
FDA-Cleared Indications
- Used to introduce interventional devices into the peripheral and neurovascular vasculature.
- Used to provide a conduit and support for diagnostic or therapeutic devices during endovascular procedures.
- Intended for percutaneous intravascular procedures under imaging guidance.
Clinical Applications
- Providing distal access and support during endovascular treatment of intracranial aneurysms.
- Supporting delivery of working devices during neurovascular embolization procedures.
- Providing a stable catheter pathway for diagnostic angiography or therapeutic intervention in the cerebral circulation.
Reported off-label uses
- Use as a large-bore support or distal-access catheter in selected non-neurovascular endovascular procedures has been described, but this is outside the device's primary neurovascular labeling and should be determined by the treating physician.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes three studies, ranging from 2016 to 2024, encompassing various study types such as RCTs and case series. These studies focus on the catheter's application in neurovascular interventions.
Reported Outcomes
Published studies report that the Envoy Distal Access DA Guiding Catheter offers sufficient supportability and distal navigability, crucial for successful coil embolization of anterior circulation cerebral aneurysms. The catheter's length and stability are also highlighted as important factors in its effective use.
Safety Profile
Reported complications include challenges in managing intraoperative complications during the use of the catheter, as noted in a technical case report. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Practical Considerations
- The listed device is a 6 French catheter available in 95 cm and 105 cm lengths, with straight, XB, MPD, and MPC configurations.
- It is advanced through a compatible introducer or guide catheter over a guidewire under fluoroscopic imaging; vessel size, tortuosity, and access route must be assessed before use.
- Compatibility with guidewires, microcatheters, embolic devices, and other instruments should be confirmed in the current manufacturer instructions for use.
- The record does not establish MRI safety. MRI conditions should be verified in the current labeling before scanning a patient with the catheter in place.
- Potential complications of catheterization include vessel injury, dissection, perforation, thrombosis, embolization, bleeding, infection, vasospasm, and neurologic events.
Frequently Asked Questions
What are the clinical indications for Envoy Distal Access DA Guiding Catheter?
The catheter is indicated for use in neurovascular interventions, particularly for endovascular coiling of cerebral aneurysms in the anterior circulation.
What outcomes have been reported in clinical studies?
Studies report effective supportability and navigability, essential for successful coil embolization of anterior circulation aneurysms.
What complications have been reported?
Reported complications include intraoperative challenges, though specific adverse events are not detailed in the evidence provided.
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.