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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 510K
Number K140080 ↗
Decision Date April 24, 2014
Product Code DQY
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.
Clinical Applications
This catheter is commonly used in the endovascular coiling of intracranial aneurysms, especially in the anterior circulation. It is valued for its ability to provide both support and navigability during complex neurovascular procedures.
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.
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.