Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device.
Endobronchial ultrasound with transbronchial needle aspiration ( EBUS-TBNA ) is used for the diagnosis and staging of lung cancer. This procedure is performed by inserting a long, flexible fine needle through a bronchoscope for biopsy and pathological analysis. The cellular material collected can be viewed under a microscope to determine if a mass is malignant and identify tumor-specific mutations to guide treatment.
The EndoCore is a novel device designed to enhance the outcomes of this procedure. The device is powered by a motor that rotates the needle during biopsy to facilitate cellular harvesting. This unique rotary motion enables the needle to shear off large tissue samples that can help physicians make a comprehensive diagnosis.
“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,” said Dr. Joseph Romero, a Pulmonologist at Morton Plant Hospital in Clearwater, FL. “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 tumors, metastatic disease, lymphoma, and benign diseases such as sarcoidosis where traditional EBUS-TBNA has a lower yield.”
The EndoCore builds upon Praxis’ existing product portfolio which includes the CytoCore, a motorized percutaneous fine needle biopsy device that received FDA clearance in March 2020. Together these products show promise to revolutionize the way fine needle biopsies are being performed and continue Praxis’ mission to improve the lives of patients through advancements in technology.