Spirus Medical, Inc. (www.spirusmed.com), a leading developer of diagnostic and therapeutic advancement systems for gastroenterology announces a series of pan-endoscopies in an average time of 60 minutes, using a flexible endoscope with an integral drive to power a single use spiral component. The initial clinical series, which was conducted outside the U.S., showed unparalleled ability to navigate the intestinal tract.
In the clinical studies, procedures were performed from a combined anal and oral route. Of the series of ten pan-endoscopies, one examined the entire small bowel from the oral route in 24 minutes; another examined the entire small bowel from the anal route in 30 minutes. Current endoscopic modalities rarely accomplish complete GI examinations and often require several hours when they do.
"The power spiral endoscope is a truly game-changing technology that has immediate applications in how gastroenterologists evaluate intestinal disorders, with an additional range of potential applications in patients with surgically-altered anatomy—e.g., bariatric surgery," said Dr. Oleh Haluszka, Director, GI Endoscopy at Fox Chase Cancer Center, Philadelphia. Using the powered scope for the first time, Dr. Haluszka was able to negotiate the GI tract from mouth to colon in 24 minutes.
Spirus Medical has developed the Endo-Ease® line of devices aimed at revolutionizing GI endoscopy which are extensively used today to access remote areas in the small bowel and in the colon. The power spiral endoscope is the latest innovation of the technology which integrates the spiral mechanism directly into a flexible scope. In the study, powered spiral endoscopy demonstrated rapid and complete GI access and could give physicians the ability to diagnose and treat immediately as compared to having the patient return for multiple diagnostic and/or therapeutic procedures.
Physicians participating in the initial study believe the power spiral endoscope's ability to rapidly diagnose and treat intestinal lesions makes it a candidate to quickly supplant capsule endoscopy. The latter technology has been found to have numerous drawbacks according to the clinicians, including the fact that capsule endoscopy is often inconclusive and patients are required to undergo a second procedure for treatment if pathology is identified in the first round of examination.
"The extremely successful clinical evaluations over the last several months made it clear that we have created a powerful endoscopic tool that will be a disruptive force in the GI marketplace. It will create a paradigm shift that will change the way endoscopy is performed," said Steven Tallarida, President and CEO. "Best of all, the initial response from the clinicians experienced with power spiral suggest there will be a substantial medical benefit for millions of patients worldwide."
The power spiral endoscope opportunity includes a capital equipment component (scope/ light source/processor) as well as a disposable spiral component which is replaced after each use. "The power spiral can immediately capitalize on a $100 million market opportunity for the disposable spiral component alone," said Bob Ailinger, COO of Spirus. According to iData Research, projected growth in the marketplace over the next five years will create a commercial opportunity estimated at $500 million just in the small bowel segment of the overall market.
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