Minnesota-based Entellus Medical's new FinESS Endoscope has received the US Food and Drug Administration (FDA) 510(k) clearance
The endoscope is used with the FinESS Sinus Treatment, which employs minimally-invasive balloon dilation to open narrowed sinus drainage paths and relieve symptoms in patients with recurrent or chronic sinusitis.
The new Entellus endoscope enables treatment of maxillary and anterior ethmoid sinusitis patients by delivering enhanced image quality and visualization of the sinus thereby potentially reducing procedure time.
The Entellus FinESS system is the balloon dilation system that predictably allows direct visualization of the maxillary sinus opening.
Entellus Medical CEO Brian Farley said their new endoscope provides ENT physicians a clear visual perspective to quickly guide sinus balloon catheter placement and successfully treat patients in the doctor’s office.
"This practice-changing technology greatly enhances the treatment options for physicians and their patients who suffer from sinusitis," Farley said.