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Spirus Medical Starts US Evaluations With Advancement System For Colonoscopy; Receives 510(k) For New Enteroscopy Device
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.
Spirus Medical, Inc
http://www.spirusmed.com
Spirus medicale Începe SUA Evaluãrile Cu Progresul sistem de colonoscopie; primeste 510 (k) pentru noile Enteroscopy Aparat - Spirus Medical Starts US Evaluations With Advancement System For Colonoscopy; Receives 510(k) For New Enteroscopy Device - articole medicale engleza - startsanatate