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penumbra lp coil system
Penumbra
Summary: The Penumbra LP Coil System is a medical device used for mechanical thrombectomy in venous systems. It is typically utilized by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway
510K
Number
K230284 ↗
Decision Date
October 25, 2023
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Penumbra LP Coil System was cleared through the FDA 510(k) pathway on October 25, 2023. It is manufactured by Penumbra and classified as a Class 2 device under product code HCG.
What It Is
The Penumbra LP Coil System is designed for mechanical thrombectomy, a procedure to remove blood clots from the venous system. It consists of coils that are delivered via a catheter to the site of the clot, where they help to capture and extract the thrombus. This system is particularly useful in cases where pharmacological thrombolysis is contraindicated or ineffective.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant for patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) where rapid clot removal is necessary. The device is suitable for use in hospitals with specialized endovascular teams and is often employed in emergency situations or planned interventions.
Indications for Use
The FDA indicates this device for mechanical thrombectomy in the venous system. Clinically, this means it is used to remove blood clots from veins, which can help restore normal blood flow and prevent complications like post-thrombotic syndrome.
Practical Considerations
The Penumbra LP Coil System comes in various sizes to accommodate different vessel diameters and clot burdens. It is compatible with standard endovascular techniques and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in endovascular procedures to use this device effectively.
Frequently Asked Questions
What is the Penumbra LP Coil System used for?
It is used for mechanical thrombectomy to remove blood clots from the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in the venous system, meaning it is used to remove blood clots from veins.
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.