Navigation Links
Spirus Medical Announces 510(k) Clearance from FDA for Expanded Use of Endo-Ease(R) Discovery SB(TM)
Date:5/18/2008

Unique 'rotate to advance' device enables deeper enteroscopy

SAN DIEGO, May 18 /PRNewswire/ -- Spirus Medical, Inc. (http://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, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. MSU engineering team designs innovative medical device
2. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
3. Providence St. Joseph Medical Center, Caregivers Reach Agreement on a Union Contract
4. Owner and Operator of Florida Durable Medical Equipment Company Convicted of Medicare Fraud
5. Father and Daughter From Tanzania Receive Their First Medical Examination in Newport Beach
6. Doctors and medical ethicist discuss whether doctors should participate in capital punishment
7. Preparation for Natural Disasters Critical for People With Diabetes, Chronic Medical Conditions
8. Doctors and Medical Ethicist Discuss Whether Doctors Should Participate in Capital Punishment
9. Symmetry Medical Completes Acquisition Of Specialty Surgical Instruments
10. Milestone Scientific Announces Successful Completion of its Collaboration Agreement With Carticept Medical
11. FDA Seeks to Regulate Complementary and Alternative Medicine; Products Such as Vegetable Juice Could Be Restricted for Medical Use
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... ... May 26, 2016 , ... Cardiac arrhythmia is ... impact on long-term patient survival, reports a team of UPMC researchers in the ... in the Journal of Thoracic and Cardiovascular Surgery, provide critical information that will ...
(Date:5/26/2016)... ... May 26, 2016 , ... MadgeTech will be showcasing its ... manufactured in Warner, New Hampshire at the MadgeTech headquarters. With products sold in more ... trusted by government agencies, including NASA. , In 2012, NASA strategically set up ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... Retinal Degeneration” for the Foundation Fighting Blindness, Long Island Chapter on June 4, ... the public. , Dr. Maisel, founder of Retina Group of New York ...
(Date:5/26/2016)... ... ... In an effort to provide hair restoration information to the widest possible audience, Dr. Parsa ... not use the app. Dr. Mohebi, the founder of Parsa Mohebi Hair Restoration, is making ... , Dr. Mohebi says, “The positive response to the Snapchat videos we started last month ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership of Life Science Logistics ... organization has earned its ISO 13485 certification, indicating the company’s quality control system ... and policies associated with ISO quality standard 13485. , BSI Group America, ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... , May 25, 2016  Granger Diagnostics today ... test for wounds and infections. This test ensures ... and select viruses. The test requires only a ... David G. Bostwick , MD, ... to facilitate wound healing: "We are excited to ...
(Date:5/24/2016)... May 24, 2016 Niederländische ... gebracht, die es Ärzten erlaubt, ihre Expertise weltweit ... MDLinking kombiniert Live Streaming mit einer Instant-Messaging-Funktion und ... kommunizieren. Mediziner in Europa, Afrika, Asien und den ... für die Plattform registriert. Information und ...
(Date:5/24/2016)... 24, 2016 ARANZ Medical  Ltd ... healthcare sector, has been named the Coretex Hi-Tech Emerging Company ... Dr Bruce Davey , CEO of ARANZ ...  It,s really good to be recognised for the work we ... are used in 35 countries around the world from Sub-Saharan ...
Breaking Medicine Technology: