Olympus said it has won FDA clearance for its EZ Shot Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB).
The approvals “can drive improved staging of disease and the potential to more easily connect patients to precision medicine options,” the company said in a statement.
The EZ Shot 3 Plus 19 G, 22 G and new 25 G have been designed for use with an Olympus endoscopic ultrasound system for ultrasonically guided FNA and FNB of submucosal and extramural lesions within the gastrointestinal tract, such as pancreative masses, mediastinal masses, perirectal masses and lymph nodes. The larger tissue samples that FNB provides may enable more precise diagnosis and rapid cytodiagnosis, a technique for on-the-spot pathological diagnosis of tissues collected during surgery, the company said.
“A needle is judged by the ability for the cytologist or pathologist to make a diagnosis based on the cells or tissues collected,” said Kurt Heine, group vice president of Olympus America’s endoscopy division, in the statement. “We listened to our customers’ challenges in access, sample volume, the ease of visualizing the needle on ultrasound and the needle’s ability to retain its shape after multiple passes.
“We are proud to have addressed these combined challenges, producing a solution that fits squarely into the value-based paradigm of cost reduction with improved patient outcomes and satisfaction,” Heine added. “The indication of not just FNA but now FNB is an important added tool in the fight against disease.”