Internal Medicine News

Mon, 03 Nov 2008 00:00:00 -0700

U.S. Multi –Center Study Underway for Discovery SB
Patient enrollment for the Discovery SB device Study has recently begun. Eight Clinical sites from across the country have received approval from their institutional review boards (IRB), and we anticipate an additional three sites will Receive IRB approval shortly.
The University of North Carolina at Chapel Hill was the first site to Begin enrolling patients. Principal Investigator, Douglas Morgan, MD and his group worked closely with us to develop a data collection system and optimized the study design. Headed by Robert Sandler, MD, MPH; the UNC Center for Gastrointestinal Biology and Disease is a specialty group within the university that will collect, store and report on the study with a database specifically designed for our application. Dr. Sandler is a Professor at UNC, the vice president of the American Gastroenterology Association, and a Member of the National Commission on Digestive Diseases.
Other Nationaly recognized physicians participating in the study or obtaining approval from their institutional boards to participate are listed in the table below.
Spirus Medical Announces 510(k) Clearance from FDA For Expanded Use of Endo-Ease® Discovery SB™

Unique “rotate to advance” device enables deeper enteroscopy

SAN DIEGO, CA, May 18, 2008 — 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

Spirus Medical's Endo-Ease™ Advancement System for Colonoscopy Now "CE Marked" for Sales in Europe

Company lays groundwork for product expansion overseas

STOUGHTON, MA, January 5, 2007 - Spirus Medical, Inc. (www.spirusmed.com) today announced that it has CE Marked its Endo-Ease Advantage™ and Endo-Ease Vista™ products for colonoscopy and is planning to market the products in Europe. The two products leverage the company's one-of-a-kind Endoluminal Advancement System (EAS™), used in conjunction with a conventional colonoscope to aid advancement through the colon with the ease of rotation. The EAS system uses a soft spiral component fixed on an active, flexible overtube to facilitate a more efficient approach to colonoscopy.
"Both Endo-Ease Advantage and Vista have been extremely well received by gastroenterologists and surgeons in the US, and we are now strategically positioning ourselves to market the Endoluminal Advancement System across Europe," said Steven Tallarida, president and CEO of Spirus Medical. "With the application of the CE Mark on these two revolutionary devices, Spirus is building a solid foundation for growth in the European Union."
Both Endo-Ease products attach easily onto a slim or pediatric colonoscope. Endo-Ease Advantage and Endo-Ease Vista can help move the colonoscope through the colon and also provide a conduit through which the scope can be advanced. Other products in the pipeline utilizing Spirus Medical's revolutionary platform technology include the Endo-Ease DiscoveryT SB for small bowel enteroscopy and the Uro-EaseT family of products for urology.
The shorter Endo-Ease Advantage is designed to aid advancement of a colonoscope through the tortuous sigmoid colon, where physicians often experience the most difficulty. Once the sigmoid colon has been traversed, the scope is unlocked from the device. The Endo-Ease Advantage then remains in place to stabilize the sigmoid colon while the scope is advanced traditionally through the rest of the colon to complete the procedure. The Endo-Ease Vista is a longer version designed to enable rotational advancement of the scope beyond the sigmoid colon. The Endo-Ease Vista also provides a stable conduit through which a colonoscope can be passed to complete a colonoscopy.
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) 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.

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