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callispheres embolic microspheres 8spheres embolic microspheres
Suzhou Hengrui Callisyn Biomedical
Summary: CalliSpheres embolic microspheres are used for embolization procedures, primarily in oncology settings to treat tumors. They are utilized by interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K173871 ↗
Decision Date
September 17, 2018
Product Code
NAJ
Device Class
Class 2
Evidence
0 studies
The CalliSpheres embolic microspheres were cleared through the FDA 510(k) pathway on September 17, 2018. Manufactured by Suzhou Hengrui Callisyn Biomedical, this device is classified as Class 2.
What It Is
CalliSpheres embolic microspheres are small, spherical particles designed for embolization, a procedure that blocks blood flow to certain areas, such as tumors. These microspheres are delivered via a catheter into the blood vessels feeding a tumor, causing ischemia and necrosis of the tumor tissue. This device is particularly useful in interventional oncology for the treatment of liver tumors.
Clinical Applications
The device is commonly used in transcatheter arterial chemoembolization (TACE) procedures, particularly for hepatocellular carcinoma (HCC). It is often employed in patients with liver cancer who also have complications such as hypersplenism. Interventional radiologists in hospital settings typically use this device, and it is suitable for patients who are not candidates for surgical resection.
Indications for Use
The FDA has cleared the CalliSpheres embolic microspheres for use in embolization procedures, specifically targeting tumors like hepatocellular carcinoma. It is indicated for patients with liver cancer, especially those with associated conditions like hypersplenism.
Practical Considerations
These microspheres come in various sizes to accommodate different vessel diameters and tumor types. They are compatible with standard catheter systems used in embolization procedures. Clinicians should consider the size and location of the tumor when selecting the appropriate microsphere size.
Related Literature
The linked study evaluated the efficacy and safety of using CalliSpheres microspheres in combination with partial splenic embolization for treating hepatocellular carcinoma with hypersplenism. The study found that this combination approach was effective in managing HCC while addressing complications like splenomegaly. However, the study was limited by its early-stage design and the need for longer-term follow-up to fully assess outcomes.
Frequently Asked Questions
What is CalliSpheres embolic microspheres used for?
They are used for embolization procedures to treat tumors, particularly in the liver.
What specialties typically use this device?
Interventional radiologists primarily use this device in oncology settings.
What are the FDA-cleared indications?
The device is indicated for embolization procedures targeting tumors such as hepatocellular carcinoma, especially in patients with liver cancer and hypersplenism.
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.