FDA Clearance for 3NT Peregrine™ Sinus Endoscope

sinus surgery endoscope

ENT Endoscope specialist, 3NT Medical has gained FDA clearance for its Peregrine™ Drivable ENT Scope. Peregrine is designed to provide ENT surgeons with unparalleled views of the sinus anatomy to enhance the surgical experience.

Background

Access and visualization deep within the sinuses are challenges for ENT surgeons. The anterior and lateral wall of the maxillary sinus and the superior and lateral aspects of the frontal sinus, are difficult to reach endoscopically. As a result, pathology, such as inverted papilloma, most frequently recurs in tumors in those areas that are difficult to access. More than 500,000 patients undergo sinus surgery in the U.S. annually. The majority of these receive simultaneous treatment for the maxillary and frontal sinuses. 

3NT’s Peregrine Drivable ENT Scope allows ENT surgeons to access the furthest reaches of the sinuses to visualize anatomic landmarks up-close. The company says its system delivers excellent image quality and minimal resection, both intra- and post-operatively. The system achieves these benefits through novel mechanics which enable the surgeon to angulate the device’s 2.3mm tip sharply. Once oriented the clinician can then advance it further in the direction of the turn. Importantly this is all achieved with single-hand operation.

ENT specialist can use Peregrine alongside the traditional 0° rigid endoscope. Alternatively it can be the main endoscope in the operating room. The system operates through a proprietary, small-footprint video console. This means there is no the need for bulky and expensive endoscopy towers that traditional endoscopes require.

As a single-use sterile device, Peregrine aims to enhance safety for both patients and medical staff by eliminating the risk of cross-contamination. Furthermore it can reduce the costs and inconvenience of sterilization that traditional capital endoscopes incur.

In a study comparing Peregrine to rigid endoscopes, Peregrine was able to view 100 percent of the frontal and sphenoid sinuses and 97.1 percent of the maxillary sinus. This compares with 45.3 percent, 53.3 percent and 39.4 percent, respectively, for 4mm rigid endoscopes ranging from 0° to 70°.4

Company comments

According to 3NT Medical CEO Ehud Bendory; “Assessing the sinuses from a distance is now a thing of the past with Peregrine. This new scope joins our commercially-available Colibri™ Micro ENT Scope for otologists. It demonstrates that 3NT Medical is executing on its vision of creating a portfolio of endoscopes designed specifically for ENT use”

“We designed Peregrine exclusively for ENT surgeons to enable a better surgical experience for them as they strive to provide better outcomes and an enhanced experience for their patients.”

View the extraordinary maneuverability of the Peregrine Drivable ENT Scope here.

Source: 3NT Medical

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published: August 11, 2021 in: Approval/Clearance, ENT

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