Spirus Medical, Inc., a leading developer of diagnostic and therapeutic advancement systems for gastroenterology and urology, has received 510(k) clearance from the FDA for an expanded indication for use with its Endo-Ease Discovery SB device in endoscopic procedures.
Spirus Medical has developed the Endo-Ease line of products aimed at revolutionizing GI endoscopy. The products' patented spiral feature promotes easier advancement of an endoscope, which helps physicians examine and treat GI disorders.
In clinical evaluations using a slim enteroscope, the Spirus Medical Endo-Ease Discovery SB 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. Because physicians are able to provide better diagnosis and treatment with greater small bowel access, the discovery SB is uniquely positioned to expand the capabilities of the endoscopist.
There are over twelve million EGD (esophagogastroduodenoscopy) procedures performed worldwide each year. A significant portion of those patients could benefit from an examination of the small bowel extending beyond the reach of gastroscopy, according to the company. Due to the limitations of existing technology, only a small fraction of these procedures are currently performed using an enteroscope to achieve greater insertion depth in the small bowel. The Spirus Endo-Ease Discovery SB addresses this emerging market opportunity, which could exceed US $1 billion.
"Studies with the Endo-Ease Discovery SB show that safe and easy deep small bowel insertion is possible" said Dr Paul Akerman, director of Therapeutic Endoscopy and Endoscopic Oncology at Rhode Island Hospital, and member of the Spirus Medical Advisory Board. "Spirus' technology is overcoming the challenges endoscopists have traditionally faced when evaluating the small bowel".
"We're pleased to have received the expanded indication for the discovery SB system, which we began marketing earlier this year," said Steve Tallarida, Spirus Medical president and chairman. Spirus has established a patient registry at top medical institutions across the US to document findings and results from continued use of the discovery SB.
The company also announced 510(k) clearance for a proprietary medical lubricant it developed for use with discovery SB applications and to facilitate other endoscopic procedures.