Olympus has launched SecureFlex, a single-use fine needle biopsy device. It will become commercially available in Europe and Japan in autumn 2025, with future global rollout once regulatory requirements have been met.

SecureFlex is designed for use with an ultrasound endoscope and supports endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) of submucosal and extramural lesions in the gastrointestinal (GI) tract. It’s main clinical application is diagnosis of diseases like pancreatic cancer.

EUS-FNB combines ultrasound and endoscopy tech so physicians can gather tissue or cell biopsies from areas like the pancreas that can’t be directly accessed by the endoscope. A needle biopsy may be done through the wall of the GI tract, with the ultrasound scope inserted orally and ultrasound imaging used for sub-mucosal visualization. Collected samples are then sent for pathological evaluation to determine if the lesion is benign or malignant.

SecureFlex features a dual-beveled raptor tip with multi-dimensional cutting surfaces. According to the company, this allows collection of larger, intact tissue samples while preserving cellular architecture through precision tissue execution. The outer distal cutting edge surface forms a fine edge to support smooth tissue puncture, and the inner proximal cutting surface minimizes tissue escape.

EUS-FNB procedures typically require the needle’s insertion into tough-to-access location like the pancreatic head and uncinate process. SecureFlex’s nitinol construction and multi-layer sheath design help provide effective access to complex anatomical structure without frequently adjusting the scope, Olympus said.