Magtrace and Sentimag Magnetic Localization System - P160053/S002
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Magtrace and Sentimag Magnetic Localization System
PMA Applicant: Endomagnetics Ltd.
Address: 330 Cambridge Science Park, Milton Road, Cambridge, CB4 0WN, UK
Approval Date: December 6, 2022
Approval Letter: Approval Order
What is it?
The Magtrace and Sentimag Magnetic Localization System guides lymph node biopsies in patients with breast cancer. It includes the Magtrace injectable magnetic tracer and the Sentimag magnetic sensing probe and base unit.
The system assists in sentinel lymph node biopsies which are used to determine whether the cancer has spread beyond the initial tumor into the lymph nodes.
This approval is for using Magtrace® and Sentimag® Magnetic Localization System to assist in localizing lymph nodes draining a tumor site, as part of a sentinel lymph node biopsy procedure, in patients with breast cancer undergoing a mastectomy or lumpectomy. For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, Magtrace® is indicated to be injected only peritumorally. Magtrace® is intended and calibrated for use ONLY with the Sentimag® system.
How does it work?
Magtrace is made of iron oxide and a sugar coating (carboxydextran) held in salt water. This magnetically detectable liquid product is injected into the patient’s breast and will collect in the regional lymphatics and migrate to lymph nodes.
Once Magtrace has migrated to the lymph nodes, the surgeon will then be able to identify the location of these nodes by using Sentimag a magnetic probe first through the skin and then during surgery. The lymph nodes are then removed and tested for the presence of cancer cells. Detection of the sentinel lymph nodes draining a tumor site may inform further treatment.
When is it used?
The Magtrace and Sentimag Magnetic Localization System is used in patients with breast cancer undergoing mastectomy or lumpectomy. The device is used to locate lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure.
For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, Magtrace is indicated to be injected only in the area around the tumor (peritumorally).
What will it accomplish?
In clinical studies, Magtrace and Sentimag performed as well as the traditional techniques for identifying sentinel lymph nodes, which include the use of radioisotopes and blue dye, but without the need to expose the patient to radiation. Detection of the sentinel lymph nodes that drain a tumor site can help doctors and patients make treatment decisions.
When should it not be used?
Magtrace should not be used in patients with:
- Hypersensitivity to iron oxide or dextran compounds
- Iron overload disease
- Metal implants in the armpit area or in the chest.
It should also not be used for patients who:
- Will have neoadjuvant chemotherapy where magnetic resonance imaging (MRI) will be the primary imaging used to monitor treatment progress.
- Require post-lumpectomy imaging with breast MRI.
May be negatively (adversely) affected by (tattooing) skin discoloration.