📊 Evidence-Based Reference
The Solopath Balloon Expandable Transfemoral Introducer
Onset Medical
Summary: The SoloPath Balloon Expandable Transfemoral Introducer is a device used for vascular access in procedures like TAVI. Key evidence suggests it may reduce vascular complications in patients with peripheral artery disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K100819 ↗
Decision Date ?
August 2, 2010
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The SoloPath Balloon Expandable Transfemoral Introducer was cleared by the FDA via the 510(k) pathway on August 2, 2010. It is manufactured by Onset Medical and classified as a Class 2 device.
What It Is
The SoloPath Balloon Expandable Transfemoral Introducer is a medical device designed to facilitate vascular access by expanding and collapsing as needed. It is primarily used in endovascular procedures such as transcatheter aortic valve implantation (TAVI).
FDA-Cleared Indications
- Vascular access for introducing diagnostic or therapeutic catheters and other intravascular devices.
- Transfemoral access in endovascular procedures requiring an introducer sheath.
- Use in procedures requiring large-bore arterial access, according to the device labeling and sizing specifications.
Clinical Applications
- Obtaining femoral arterial access for catheter-based cardiovascular procedures.
- Providing a conduit for large catheters or devices during transfemoral endovascular treatment.
- Supporting transfemoral access during structural-heart procedures such as transcatheter aortic valve implantation when compatible with the labeled device configuration.
Evidence Summary
The available literature includes 9 studies, comprising various types such as RCTs and case series, conducted between 2016 and 2022. These studies explore the device's efficacy and safety in facilitating vascular access.
Reported Outcomes
Published studies report that the SoloPath device may enhance access-site availability and reduce vascular complications in TAVI patients, particularly those with peripheral artery disease. It has been associated with successful procedures in complex vascular access scenarios.
Safety Profile
Reported complications include vascular complications, although the studies reviewed did not report significant adverse events directly attributed to the device. The safety profile appears favorable in the context of the reviewed literature.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to confirm findings in larger, more diverse populations.
Practical Considerations
- The appropriate sheath diameter and length depend on the planned device, access-vessel anatomy and the manufacturer's compatibility specifications.
- The device is inserted through transfemoral vascular access under fluoroscopic or other appropriate imaging guidance, with balloon expansion performed according to the instructions for use.
- Small, calcified, tortuous or severely diseased access vessels may increase the risk of dissection, perforation, bleeding or vessel occlusion; preprocedure imaging and careful patient selection are important.
- Use only with compatible guidewires, catheters and intravascular devices listed in the current instructions for use.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; this record does not establish that the device is MR Safe or MR Conditional.
Frequently Asked Questions
What are the clinical indications for SoloPath Balloon Expandable Transfemoral Introducer?
The device is indicated for use in procedures requiring large-bore vascular access, such as TAVI, particularly in patients with peripheral artery disease.
What outcomes have been reported in clinical studies?
Studies report improved access-site availability and reduced vascular complications in patients undergoing TAVI.
What complications have been reported?
Safety data indicate minimal adverse events, with vascular complications being the primary concern, though not directly attributed to the device.
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.