Cancer healthcare company Endomagnetics has announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to initiate a pivotal clinical trial to evaluate the safety and effectiveness of the SentiMag® and Sienna+® magnetic sentinel lymph node biopsy system in the management of breast cancer.
The SentiMag® and Sienna+® system gives surgeons the ability to locate the sentinel lymph nodes draining a tumour accurately and reliably as part of cancer staging – the process of determining whether cancer has spread.
The system has already been tested in 10 clinical trials across Europe, involving more than 1,700 breast cancer patients, and published results have shown that the magnetic technique is safe, and clinically equivalent to the current gold standard for sentinel lymph node detection.
Dr Quentin Harmer, CTO of Endomagnetics, commented: “The IDE approval is a key step towards bringing this technology to US patients and builds on our European approval. By removing the requirement for radioactive isotopes, we can significantly improve the availability and convenience of the cancer staging procedure for patients and surgeons.”
The multisite pivotal trial is expected to start in January 2015 with six hospitals participating from across the US. The trial is designed to collect safety and effectiveness data to support the future submission of a premarket approval (PMA) application to the FDA for SentiMag® and Sienna+®.
Dr Harmer continued: “Patient comfort and quality of life are behind everything we do, and our goal is to make our products accessible to as wide an audience as possible. In 2011 Sienna+® was the first tracer to gain Europe-wide CE mark approval for localising lymph nodes. The unique magnetic technology means that patients can now access an approved non-radioactive approach for this important cancer staging procedure. I am delighted that in just two years, already more than 3,000 patients across Europe have benefitted from this revolutionary technology.”