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solopath re-collapsible access system
Onset Medical
Summary: The Solopath Re-Collapsible Access System is a medical device used to facilitate vascular access during procedures such as TAVR. It is primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K121404 ↗
Decision Date
May 3, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Solopath Re-Collapsible Access System received FDA clearance through the 510(k) pathway on May 3, 2013. It is manufactured by Onset Medical and is classified as a Class 2 device under product code DYB.
What It Is
The Solopath Re-Collapsible Access System is a specialized sheath designed to provide vascular access during procedures like transcatheter aortic valve replacement (TAVR). It features a balloon-expandable, re-collapsible design that allows it to be inserted into small vascular pathways and then expanded to facilitate device delivery. This design aims to minimize vascular trauma and complications during complex interventions.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly during TAVR procedures. It is beneficial for patients with small iliofemoral access pathways, typically those with vessel diameters of 5.0 mm or less. The device is used in hospital settings, often in catheterization labs or hybrid operating rooms, and is crucial for procedures requiring precise vascular access.
Indications for Use
The Solopath Re-Collapsible Access System is indicated for use in patients requiring vascular access during procedures like TAVR, especially those with small or challenging vascular anatomy. It is designed to facilitate the safe introduction of larger devices through smaller vessels.
Practical Considerations
The device is compatible with various vascular access techniques and can be used in conjunction with other interventional tools. It is important to select the appropriate size based on the patient's vascular anatomy and ensure compatibility with the devices being introduced. Proper technique in expanding and collapsing the sheath is crucial for minimizing complications.
Related Literature
The linked study from 2017 assessed the use of a balloon-expandable, re-collapsible sheath in TAVR procedures, focusing on patients with small iliofemoral access. The study found that using this sheath could minimize vascular complications, making it a viable option for patients with challenging access pathways. However, the study's limitations include a small sample size and a focus on a specific patient population, which may not be generalizable to all TAVR candidates.
Frequently Asked Questions
What is Solopath Re-Collapsible Access System used for?
It is used to provide vascular access during procedures like TAVR, especially in patients with small or challenging vascular anatomy.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device during procedures requiring precise vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access during procedures like TAVR, particularly in patients with small iliofemoral vessels.
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.