Olympus announced today the FDA clearance of its EZ Shot 3 Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line-up for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The uncompromised access, enhanced puncturability, predictable trajectory and distinct echogenicity of the EZ Shot 3 Plus line, combined with the new 25 G offering and expanded indication for FNA and FNB, can drive improved staging of disease.
The EZ Shot 3 Plus 19 G, 22 G and new 25 G have been designed to be used with an Olympus endoscopic ultrasound system (EUS) for ultrasonically guided FNA and FNB of submucosal and extramural lesions within the gastrointesitnal tract (i.e. pancreative masses, mediastinal masses, perirectal masses and lymph nodes). FNB is an important advantage for physicians because it has been reported that the larger tissue samples it provides may enable more precise diagnosis and rapid cytodiagnosis, a technique for on-the-spot pathological diagnosis of tissues collected during surgery.
The EZ Shot 3 Plus 25 G, together with the EZ Shot 3 Plus 19 G and 22 G needles, completes the EZ Shot 3 Plus line of needles. EZ Shot 3 Plus benefits include:
- Tissue architecture: Unique Menghini needle tip design features sharp, continuous cutting edges to cleanly cut tissue specimens while preserving cellular architecture.
- Potential time and cost savings, increased efficiency: Uncompromised, accommodating access to lesions, through difficult scope positions, is made possible by a combination of needle material and multi-layer coiled sheath. Smooth needle passage and responsiveness to handle motion are achieved by way of the multi-layer coiled sheath and needle flexibility.
- More precision targeting of samples: Flexible needle design, smooth cutting edge, and distinct echogenicity (for distinct hyperechoic appearance on ultrasound) combine for precise access, clean cuts and visualization of the target lesion.
“I have been very impressed with the maneuverability of the EZ Shot 3 Plus line,” said Dr. Allan P. Weston, MD, FACG, Digestive Health Center of the Four States. “While the needle competes with others in its ability to obtain excellent tissue samples for proper diagnosis, it exceeds predecessors, due to its flexible sheath, in its ability to pass readily through the echoendoscope channel and access the target lesions without requiring adjustments of the up/down knob, right/left knob or scope tip position, thereby ultimately reducing procedure duration times and enhancing efficiency.”
“A needle is judged by the ability for the cytologist or pathologist to make a diagnosis based on the cells or tissues collected. 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,” said Kurt Heine, Group Vice President of the Endoscopy Division at Olympus America Inc. “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. The indication of not just FNA but now FNB is an important added tool in the fight against disease.”