Praxis Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its EndoCore Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) fine needle biopsy device.
The American medical device company has designed the EndoCore EBUS-TBNA biopsy device for the diagnosis and staging of lung cancer.
During the procedure with the device, a long, flexible tiny needle is inserted through a bronchoscope to perform a biopsy and pathological analysis.
By using a microscope, the cellular material obtained can be examined to determine whether a mass is cancerous and to find mutations specific to the tumour, which will help in treatment, Praxis Medical said.
EndoCore is said to be a new device designed to improve the outcomes of this procedure. It is powered by a motor that rotates the needle during biopsy to make cellular harvesting easier.
The needle’s distinctive rotational action allows it to shear off substantial tissue samples, which can assist medical professionals in developing a thorough diagnosis, according to the medical device firm.
Clearwater, Florida-based Morton Plant Hospital pulmonologist Joseph Romero said: “We are excited by the implications of how this device could progress the standard of care.
“Improving EBUS-TBNA sensitivity, diagnostic yield, and ancillary testing capabilities would allow for an expedited workup of all types of adenopathy while maintaining procedural efficiency and low complication rates.
“We expect the EndoCore device will collect larger samples of tissue with higher cellularity which could translate to higher success rates for ancillary testing.
“This will be particularly important for rarer tumours, metastatic disease, lymphoma, and benign diseases such as sarcoidosis where traditional EBUS-TBNA has a lower yield.”
The EndoCore device expands upon Praxis Medical’s current line of products, which also includes CytoCore, a motorised percutaneous tiny needle biopsy instrument that obtained FDA clearance in March 2020.
When combined, these devices have the potential to transform the way fine needle biopsies are carried out and will advance its goal of enhancing patient outcomes by technological innovation, said Praxis Medical.
