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edwards lifesciences percutaneous sheath introducers with oligon material
Edwards Lifesciences
Summary: The Edwards Lifesciences percutaneous sheath introducers are used in vascular access procedures, primarily for embolization-coils. Key evidence highlights their use in complex interventions like transcatheter aortic valve implantation.
FDA Clearance Information
Pathway
510K
Number
K014052 ↗
Decision Date
March 8, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA via the 510(k) pathway on March 8, 2002. It is manufactured by Edwards Lifesciences and classified as a Class 2 medical device.
What It Is
The Edwards Lifesciences percutaneous sheath introducers are designed to facilitate vascular access for the delivery of embolization coils and other interventional devices. They are made with oligon material, enhancing flexibility and ease of insertion.
Clinical Applications
These introducers are commonly used in procedures requiring vascular access, such as transcatheter aortic valve implantation and other endovascular interventions. They provide a conduit for the insertion of various therapeutic devices.
Evidence Summary
The literature includes two studies, one from 2016 and another projected for 2025. These studies encompass a range of methodologies, including case reports and procedural descriptions, focusing on the device's application in complex interventions.
Reported Outcomes
Published studies report the successful use of the Edwards Lifesciences sheath introducers in facilitating complex procedures like transcatheter aortic valve implantation. The device's design allows for effective vascular access, contributing to procedural success.
Safety Profile
Reported complications include rare instances of device embolization, as noted in a case involving a patent foramen ovale occluder. Overall, the device is considered safe when used as intended, with complications being infrequent.
Evidence Limitations
The current evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of these introducers in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Edwards Lifesciences percutaneous sheath introducers?
They are indicated for use in vascular access procedures, particularly for embolization-coils and transcatheter interventions.
What outcomes have been reported in clinical studies?
Studies report successful facilitation of complex procedures like transcatheter aortic valve implantation.
What complications have been reported?
Safety data indicate rare complications such as device embolization, with overall infrequent adverse events.
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.