Olympus announced today that it has launched its SecureFlex single-use fine needle biopsy device in Europe and Japan.
The company said its rollout, starting this fall, will be followed by a subsequent global launch, subject to regulatory requirements.
Olympus designed its SecureFlex biopsy device for use with an ultrasound endoscope. It supports endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) of submucosal and extramural lesions within the gastrointestinal tract. The company said its primary clinical application comes in the diagnosis of diseases like pancreatic cancer.
EUS-FNB combines ultrasound and endoscopy to enable physicians to obtain tissue or cell biopsies of lesions from areas like the pancreas that can’t be accessed directly by the endoscope. Olympus says a needle biopsy may be performed through the wall of the gastrointestinal tract with the ultrasound scope inserted orally. This process would use ultrasound imaging for sub-mucosal visualization. It then sends collected tissue samples for pathological evaluation to label a lesion benign or malignant.
Olympus said SecureFlex addresses the need for high-quality tissue sampling. It contributes more to precise treatment planning for pancreatic cancer and other gastrointestinal diseases, the company says.
The device features a dual-beveled raptor tip with multi-dimensional cutting surfaces. It enables the collection of larger, intact tissue samples while preserving cellular architecture through precise tissue execution. This then delivers procedural efficiency. The outer distal cutting surface forms a fine edge to support smooth tissue puncture. Meanwhile, the inner proximal cutting surface minimizes tissue escape.
Olympus said the device’s nitinol construction and multi-layer sheath design also support effective access to complex anatomical structures. With this, it eliminates the need for frequent scope adjustments as well.
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