Olympus Corporation has announced the launch of SecureFlex, a single-use fine needle biopsy device, in EMEA. Designed for use with an ultrasound endoscope, SecureFlex supports endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) of submucosal and extramural lesions within the gastrointestinal tract. Its primary clinical application is in the diagnosis of diseases such as pancreatic cancer.
EUS-FNB is an advanced diagnostic technique that combines endoscopy and ultrasound to allow physicians to collect tissue or cell samples from hard-to-reach areas, such as the pancreas. During the procedure, an ultrasound endoscope is inserted orally to visualize structures beneath the surface of the gastrointestinal wall. A fine needle is then used to collect tissue from targeted lesions, which is subsequently sent for pathological analysis to determine whether the abnormality is benign or malignant.
In recent years, advances in the treatment of pancreatic cancer—including molecularly targeted therapies and immunotherapies—have increased the need for high-quality tissue sampling. For these therapies, it is often critical to obtain larger and higher-quality samples to ensure accurate treatment decisions. The newly launched SecureFlex has been developed to address these needs, incorporating feedback from physicians.
The device is equipped with a Dual-Beveled Raptor Tip designed with multi-dimensional cutting surfaces that allow for the collection of larger, more intact tissue samples compared to Olympus’ conventional needle. This precise cutting action helps preserve cellular architecture, enhancing diagnostic accuracy and procedural efficiency.
EUS-FNB procedures often require the needle to be inserted into difficult-to-access locations, such as the pancreatic head and the uncinate process. SecureFlex’s highly flexible nitinol construction, combined with a multi-layer sheath design,2 enables smooth navigation and effective access to complex anatomical structures, reducing the need for frequent scope adjustments. Additionally, the needle’s houndstooth pattern contributes to a clear ultrasound visibility.
With its combined features for flexible access, accurate targeting, and simplified precision sampling, SecureFlex aims to contribute to more precise treatment planning for pancreatic cancer and other gastrointestinal diseases.
The SecureFlex Single-use Fine Needle Biopsy Device will be commercially available in Europe and Japan in Autumn 2025, with a subsequent global rollout subject to regulatory requirements such as product registration and market clearance.
