Spirus Wins FDA Approval for Expanded Use of Endoscopy Device

Spirus Medical has received 510(k) clearance from the FDA for an expanded indication for use with its Endo-Ease Discovery SB device in endoscopic procedures.

The product’s patented spiral feature promotes easier advancement of an endoscope, which helps physicians examine and treat gastrointestinal disorders, the company said.

In clinical evaluations using a slim enteroscope, the device proved effective in achieving an insertion depth of 400 cm beyond the Ligament of Treitz and is now indicated to aid endoscopic insertion and advancement to the mid-ileum.