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solopath balloon expandable transfemoral introducer
Onset Medical
Summary: The SoloPath Balloon Expandable Transfemoral Introducer is a device used for transcatheter aortic valve replacement (TAVR) in patients with challenging vascular access. Key evidence highlights its utility in cases with suboptimal vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K092014 ↗
Decision Date
October 8, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SoloPath Balloon Expandable Transfemoral Introducer was cleared via the FDA 510(k) pathway on October 8, 2009. It is manufactured by Onset Medical and classified as a Class 2 device.
What It Is
The SoloPath Balloon Expandable Transfemoral Introducer is designed to facilitate the delivery of transcatheter aortic valves via femoral access. It employs a balloon-expandable mechanism to provide a low-profile entry and accommodate large delivery sheaths.
Clinical Applications
This device is commonly used in transcatheter aortic valve replacement (TAVR) procedures, particularly in patients with challenging vascular access due to calcification or tortuosity of peripheral arteries.
Evidence Summary
The literature includes three studies: a case series, a retrospective study, and a mixed-methods study from 2013 to 2014. These studies explore the device's efficacy in reducing vascular complications during TAVR.
Reported Outcomes
Published studies report that the SoloPath introducer is effective in facilitating TAVR in patients with difficult vascular access. It provides a smaller insertion profile and greater trackability, which may reduce procedural complications.
Safety Profile
Reported complications include vascular complications typical of TAVR procedures, such as bleeding and vessel trauma. However, the device's design aims to minimize these risks by offering a smaller insertion profile.
Evidence Limitations
The available studies are limited in scope, with small sample sizes and a lack of randomized controlled trials. Further research is needed to confirm long-term safety and efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for SoloPath Balloon Expandable Transfemoral Introducer?
The device is indicated for use in transcatheter aortic valve replacement (TAVR) procedures, especially in patients with challenging vascular access.
What outcomes have been reported in clinical studies?
Studies report that the device facilitates TAVR in patients with difficult vascular access, offering a smaller insertion profile and improved trackability.
What complications have been reported?
Safety data indicate potential complications such as bleeding and vessel trauma, though the device aims to minimize these through its design.
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.