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Olympus Gets FDA Clearance for EZ Shot 3 Plus 25 G Endoscopic Ultrasound Needle

Olympus won FDA clearance for its EZ Shot 3 plus 25 G single-use endoscopic ultrasound needle for fine needle aspiration and fine needle biopsy procedures. The company also won added indications for the entire EZ Shot 3 Plus product range.

The EZ Shot 3 Plus is intended to be used with Olympus’s endoscopic ultrasound system to perform procedures on the submucosal and extramural lesions in the GI tract, such as mediastinal and pancreative masses. Because the devices can be used to obtain relatively large biopsy samples, Olympus claims this may result in better diagnostic confidence after being analyzed in the lab.

Some of the features of the EZ Shot 3 Plus line, according to Olympus:

  • 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.

Product page: EZ Shot 3 Plus Single-Use Aspiration Needle…

Via: Olympus…



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