Healthcare Industry News:  colonoscopy 

Devices FDA

 News Release - September 5, 2006

Spirus Medical Starts US Evaluations with Advancement System for Colonoscopy; Receives 510(k) for New Enteroscopy Device

STOUGHTON, Mass., Sept. 5 (HSMN NewsFeed) -- Spirus Medical, Inc. (http://www.spirusmed.com) announced it has commenced physician evaluations of its Endo-Ease Advantage(TM) and Endo-Ease Vista(TM) products for colonoscopy at several US sites. The company also announced that it received 510(k) clearance in August from the US Food and Drug Administration for its Endo-Ease Discovery(TM) SB, a unique advancement system for enteroscopy via the upper gastrointestinal tract.

The Endoluminal Advancement System (EAS(TM)), Spirus Medical's one-of-a- kind technology, is used in conjunction with conventional flexible endoscopes. The technology uses rotation to facilitate a gentler, easier and more efficient approach to gastrointestinal (GI) endoscopy, while enhancing the scope's diagnostic and therapeutic functionality.

"Endo-Ease's EAS technology will help physicians revolutionize the way endoscopy is performed," said Bill Bookwalter, Spirus Medical vice president of sales and marketing. "We are extremely pleased with how physicians have received the products in the US and are preparing to launch the Endo-Ease for colonoscopy into an enormous US market."

Spirus is ramping up production of its two colonoscopy products for a full US market launch later this year. In preparation for the launch, Spirus Medical has appointed two new regional sales managers to further broaden its US market coverage.

"In addition to beginning our evaluations in the US, the FDA 510(k) clearance for the Endo-Ease Discovery SB marks another significant milestone for Spirus," said Robert Ailinger, chief operating officer and director of Spirus Medical.

"The small bowel remains the great frontier of endoscopy. The Discovery SB is an exciting technology that has the potential for visualization of the entire small bowel in a rapid manner and works with standard endoscopes and therapeutic accessories," said Dr. Paul Akerman, Director of Therapeutic Endoscopy and Endoscopic Oncology, Assistant Clinical Professor of Medicine & Surgery, Rhode Island Hospital, Providence, RI.

Spirus Medical continues to intensively explore other gastrointestinal applications, such as trans-gastric and trans-colonic surgery for its EAS platform technology. "Based on my experience with the Spirus devices, I believe their technology can provide a platform to make trans-gastric and trans-colonic surgery a reality," said Dr. Richard Rothstein, Chief, Section of Gastroenterology and Hepatology, Professor of Medicine at Dartmouth Medical School, Hanover, NH.

"The EAS platform technology is truly a hidden gem, with widespread applicability in GI endoscopy and beyond," said Steve Tallarida, president and chairman of the board of Spirus Medical. "Studies of new applications of the technology thus far show great promise."

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. Spirus has developed a revolutionary Endoluminal Advancement System (EAS(TM)) for GI Endoscopy that represents a significant breakthrough by enabling gastroenterologists to perform flexible endoscopy procedures more efficiently. In addition, Spirus is developing other devices incorporating this same proprietary platform technology for use in urological and gynecological procedures.


Source: Spirus Medical

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