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pathway pv atherectomy system
Pathway Medical Technologies
Summary: The Pathway PV Atherectomy System is a rotational and aspiration atherectomy device used primarily for treating peripheral arterial disease. Key evidence highlights its feasibility and safety in infrainguinal interventions.
FDA Clearance Information
Pathway
510K
Number
K081328 ↗
Decision Date
July 17, 2008
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Pathway PV Atherectomy System was cleared by the FDA via the 510(k) pathway on July 17, 2008. It is manufactured by Pathway Medical Technologies and classified as a Class 2 device.
What It Is
The Pathway PV Atherectomy System is a medical device designed for rotational and aspiration atherectomy. It is used to remove atherosclerotic plaque from peripheral arteries, particularly in the lower extremities.
Clinical Applications
This device is commonly used in the treatment of peripheral arterial disease, especially in cases of infrainguinal arterial occlusive disease and in-stent restenosis. It is often employed when traditional angioplasty or stenting is insufficient.
Evidence Summary
The available literature includes six studies, comprising randomized controlled trials, prospective, and retrospective studies, conducted between 2007 and 2013. These studies evaluate the device's safety and efficacy.
Reported Outcomes
Published studies report that the Pathway PV Atherectomy System is effective in achieving luminal gain and reducing restenosis rates in peripheral arterial lesions. The device has shown promising results in improving blood flow and reducing symptoms associated with peripheral arterial disease.
Safety Profile
Reported complications include minor procedural risks such as vessel dissection and embolization. Overall, the device has demonstrated a favorable safety profile in the studies reviewed.
Evidence Limitations
The evidence is limited by small sample sizes and the lack of long-term follow-up data. Further research is needed to confirm the long-term efficacy and safety of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Pathway PV Atherectomy System?
The device is indicated for the treatment of peripheral arterial disease, particularly in infrainguinal arterial occlusive disease and in-stent restenosis.
What outcomes have been reported in clinical studies?
Studies have reported effective luminal gain and reduced restenosis rates, with improvements in blood flow and symptom relief.
What complications have been reported?
Safety data indicate minor risks such as vessel dissection and embolization, but overall a favorable safety profile.
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.