Olympus Launches SecureFlex Fine Needle Biopsy Device in the U.S. to Advance Precision Sampling in GI Procedures

Olympus Corporation of the Americas, a global medtech leader, has announced the U.S. launch of its most advanced single-use fine needle biopsy (FNB) device. The new SecureFlex FNB needle is designed for use in endoscopic ultrasound-guided tissue sampling and supports the diagnosis of diseases such as pancreatic cancer.

The SecureFlex needle enables the collection of large, intact tissue samples and is engineered for easier access to anatomically challenging lesions, including those located in the pancreatic head and uncinate process. The device is available in 19G, 22G, and 25G sizes and will be featured during the Cedars-Sinai Endoscopy Symposium in Los Angeles from January 28–31 and at Orlando Live Endoscopy 2026 from February 4–6.

Endoscopic ultrasound-guided fine needle biopsy, or EUS-FNB, is a technique that combines ultrasound and endoscopy technologies to allow physicians to obtain biopsies of lesions that cannot be accessed directly via the endoscope. This method typically involves inserting the scope orally and guiding a biopsy needle through the gastrointestinal tract wall using real-time ultrasound imaging.

Christian Hagie, Vice President and GI EndoTherapy Business Unit Leader at Olympus Corporation of the Americas, emphasized the importance of reliability and precision in biopsy tools. “Gastroenterologists require precision and reliability when performing a biopsy for diagnostic accuracy,” Hagie said. “Olympus is excited to offer U.S. customers a dependable biopsy solution designed for precision sampling. The SecureFlex EUS-FNB needle offers an advanced design to help physicians perform efficient procedures by facilitating access to complex anatomical structures and obtaining adequate samples for diagnostic testing, even in challenging cases.”

The SecureFlex needle incorporates Olympus’ Dual-Beveled Raptor Tip, which features a distal cutting surface for smooth tissue puncture and an inner surface that helps guide more tissue into the needle. This design supports more precise tissue acquisition and better preservation of cellular architecture compared to earlier models. The needle is constructed from nitinol, a material selected for its ability to maintain shape even after multiple passes and resist deformation in tortuous anatomies. The multi-layer sheath design allows for smooth operation, and a houndstooth-patterned surface enhances visibility under ultrasound guidance.

The launch of SecureFlex comes at a time of growing need for high-quality biopsy samples to support emerging cancer therapies, including molecularly targeted treatments and immunotherapies. These therapeutic approaches often rely on robust tissue sampling for accurate diagnosis and treatment planning. Olympus designed the SecureFlex needle to meet these evolving clinical demands by enabling high-yield, structurally intact sampling.

SecureFlex is part of Olympus’ broader gastrointestinal portfolio, which also includes the EU-ME3 Ultrasound Processor. The EU-ME3 offers high-end imaging performance in a compact format, supporting both diagnostic imaging and ultrasound-guided interventions for hepatobiliary and pancreatic procedures.

As with all invasive procedures, Olympus advises clinicians that EUS-guided FNB carries potential risks, including infection, bleeding, perforation, and tumor seeding. Procedures involving cystic lesions may have a higher risk of hemorrhage and infection.

With the introduction of the SecureFlex needle in the U.S., Olympus aims to provide gastroenterologists with advanced tools that support more accurate and efficient diagnostic workflows while addressing the increasing complexity of modern cancer care.