Healthcare Industry News:  Cardiosolutions 

Devices FDA Gastroenterology

 News Release - May 18, 2008

Spirus Medical Announces 510(k) Clearance from FDA for Expanded Use of Endo-Ease(R) Discovery SB(TM)

Unique 'rotate to advance' device enables deeper enteroscopy

SAN DIEGO, May 18 (HSMN NewsFeed) -- Spirus Medical, Inc. (www.spirusmed.com), a leading developer of diagnostic and therapeutic advancement systems for gastroenterology and urology, announced at Digestive Disease Week 2008 that it 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 $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.

In 2007, Spirus Medical was recognized by Frost & Sullivan as U.S. Endoscopy Entrepreneurial Company of the Year, in recognition of its development of new technology to diagnose and treat gastrointestinal complications.

Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. In addition to Spirus, other companies that began at STD Med are Angiolink Corporation, Arthrosurface Incorporated, and Cardiosolutions, Inc. For more on Spirus Medical, visit spirusmed.com


Source: Spirus Medical

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