October 8, 2020 – Olympus (Center Valley, PA) announced today the 510(k) clearance and market availability of two colonoscopes, the PCF-H190T and the PCF-HQ190.
The products provide an extension to the existing capabilities for physicians to diagnose and treat disorders of the gastrointestinal tract, the company says.
The new PCF-H190TL/I endoscope is a slim, short-bending scope that allows for tighter angulation without compromise to the passage of treatment accessories. Used with the EVIS EXERA III imaging platform, the PCF-H190TL/I is an HD device with a 510(k) claim for Narrow Band Imaging (NBI), which indicates NBI as a “high confidence” assist to an experienced endoscopist employing a validated polyp classification system such as the NBI International Colorectal Endoscopic (NICE) classification, aiding in distinguishing diminutive adenomatous polyps from non-adenomatous polyps during colonoscopy.
The company says the device also provides:
- Better retroflexion capability, a technique associated with improved adenoma detection rate (ADR).
- Appropriate channel layout for passage of therapeutic accessories, such as for hemostasis or polypectomy.
- Improved insertability to minimize patient discomfort.
The new PCF-HQ190L/I is equipped with Dual Focus technology for increased mucosal visualization. Used with the EVIS EXERA III imaging platform, the endoscope’s NBI plus its near focus mode is associated with a greater than 90% agreement with pathological analysis in assigning post-polypectomy surveillance following colonoscopy, Olympus says. Other features include:
- A 170-degree angle of view and a new level of resolving power to support detailed observation and facilitate lesion detection.
- Responsive Insertion Technology (RIT) to facilitate complete colonoscopies and reduced cecal intubation times through better maneuverability.
- Built-in ScopeGuide Function to provide real-time 3D visualization of the scope’s position and configuration during insertion, including identification of scope loops as they form.