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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 like TAVR. It is primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K152498 ↗
Decision Date
January 5, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Solopath Re-Collapsible Access System was cleared through the FDA 510k pathway on January 5, 2016. Manufactured by Onset Medical, it 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 in procedures requiring large-bore access, such as transcatheter aortic valve replacement (TAVR). The device features a balloon-expandable and re-collapsible design, allowing it to accommodate varying vessel sizes and reduce vascular trauma during insertion and removal. This design is particularly beneficial for patients with small or challenging vascular anatomy.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly for procedures like TAVR where large-bore access is necessary. It is suitable for use in patients with small iliofemoral arteries, often seen in elderly populations or those with peripheral artery disease. The device's re-collapsible feature aids in minimizing vascular complications, making it a valuable tool in high-risk procedures.
Indications for Use
The Solopath Re-Collapsible Access System is indicated for use in procedures requiring large-bore vascular access, such as TAVR. It is designed to facilitate access in patients with small or difficult vascular anatomy, helping to minimize complications associated with traditional access methods.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. Its re-collapsible nature allows for easier insertion and removal, reducing the risk of vascular injury. Clinicians should be familiar with the device's deployment technique to maximize its benefits.
Related Literature
The linked study evaluated the use of a balloon-expandable, re-collapsible sheath in TAVR procedures, focusing on patients with small iliofemoral access. The study found that the sheath could minimize vascular complications, offering a safer alternative for patients with challenging vascular anatomy. However, the study's limitations include a small sample size and a focus on a specific patient population, which may limit the generalizability of the findings.
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.
What are the FDA-cleared indications?
The device is indicated for procedures requiring large-bore vascular access, such as TAVR, particularly in patients with small or difficult vascular anatomy.
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.