Earlier this month, Olympus Corporation, a global MedTech innovator, announced the launch of SecureFlex, a single-use fine-needle biopsy (FNB) device designed for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) procedures. The device was introduced in Europe and Japan on October 6, 2025, marking a significant advancement in endoscopic oncology diagnostics and gastrointestinal disease evaluation.
SecureFlex is specifically designed to aid in the diagnosis of submucosal and extramural lesions, such as those found in the pancreas which are often difficult to reach using conventional techniques. The device is used with an ultrasound endoscope, enabling physicians to visualize internal structures and guide the needle precisely into target lesions. This combination of endoscopy and ultrasound allows tissue sampling from deep or hard-to-access areas within the gastrointestinal tract.
The core innovation of SecureFlex lies in its nitinol-based multi-layer sheath and Dual-Beveled “Raptor Tip.” The nitinol sheath offers flexibility and shape memory, allowing stable navigation through complex anatomy, for instance, around the pancreatic head or uncinate process without repeated scope adjustments. Meanwhile, the Dual-Beveled Raptor Tip, with its dual cutting edges, facilitates smooth tissue penetration and enables the collection of larger, intact, high-quality biopsy specimens. This ensures that samples retain their cellular structure, providing pathologists with more complete tissue architecture for analysis.
This advancement holds particular importance in pancreatic cancer diagnosis, where obtaining sufficient and well-preserved biopsy samples is crucial for accurate detection and personalized treatment planning. As newer molecular and immunotherapy-based treatments become standard, the demand for precise tissue sampling has grown rapidly. SecureFlex helps meet this demand by improving the quality and quantity of biopsy samples, enabling clinicians to perform more reliable histological and molecular testing.
For patients, this translates to earlier and more accurate diagnosis, more informed treatment decisions and potentially better outcomes. For the medical community, SecureFlex represents progress toward standardizing biopsy quality, reducing sampling errors and expanding the capabilities of endoscopic ultrasound (EUS) in the diagnosis of complex gastrointestinal and oncologic conditions.
By integrating engineering precision with clinical insight, Olympus’ SecureFlex exemplifies the evolving synergy between technology and medical science, helping bridge diagnostic challenges in diseases like pancreatic cancer and advancing the global pursuit of precision medicine.
Disclaimer: This article is intended for informational and educational purposes only. It does not constitute medical advice or product endorsement. Clinical use should comply with local regulatory approvals and professional medical guidelines.
