MARLBOROUGH, Mass., March 22, 2016 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the launch of the AXIOS™ Stent and Electrocautery Enhanced Delivery System to help physicians manage two serious complications from pancreatitis using a minimally invasive endoscopic approach.
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The AXIOS System has been cleared for endoscopic management of pancreatic pseudocysts and certain types of walled-off pancreatic necrosis.1 These conditions represent two types of pancreatic fluid collections (PFCs) that occur in 5-16 percent of patients with acute pancreatitis and 20-40 percent of patients with chronic pancreatitis.2 While some of these PFCs are asymptomatic and self-resolving, others cause severe symptoms and require treatment.
Under endoscopic ultrasound (EUS) guidance, a physician can utilize the AXIOS System electrocautery-enhanced catheter to gain access to the PFC and deploy the AXIOS stent which facilitates drainage of the PFC by creating a temporary channel between the PFC and the gastrointestinal tract. The large flanges on each end of the lumen-apposing stent reduce the risk of leakage and migration. The stent – which is MRI compatible, fully covered, and self-expanding – is the only removable metal stent in the U.S. indicated for PFC drainage.
Although symptomatic PFCs can also be treated surgically, surgery has been associated with high rates of morbidity (7–37 percent) and mortality (6 percent).2 Endoscopic solutions may offer a less invasive treatment option associated with shorter hospital stays, better physical and mental health of patients, as well as lower cost.3
"The AXIOS Stent and Electrocautery Enhanced Delivery System provide a simpler and faster treatment option for patients," said Kenneth Binmoeller, M.D., California Pacific Medical Center, San Francisco, CA and the inventor of the AXIOS System. "We can now provide an endoscopic solution that provides immediate relief for these patients using one device in a single setting."
"In our practice, the AXIOS System has improved the endoscopic treatment of PFCs and walled off necrosis," said Todd Baron, M.D., professor of Medicine and director of Advanced Therapeutic Endoscopy, University of North Carolina Hospital, Chapel Hill, North Carolina. "The delivery system has improved our procedural efficiency by reducing procedure time and patient exposure to X-ray imaging. In addition, we believe that the large diameter stent design is helping to reduce the cost of care by decreasing hospital length of stay and the number of interventions needed to manage this complex disease."
1 The walled-off necrosis indication for the AXIOS Stent and Electrocautery Enhanced Delivery System is for PFCs containing less than 30 percent dead tissue.
2 Safety and Efficacy of Endoscopic Ultrasound-Guided Drainage of Pancreatic Fluid Collections With Lumen-Apposing Covered Self-Expanding Metal Stents. Shah RJ, Shah JN, Waxman I, Kowalski TE, Sanchez-Yague A, Nieto J, Brauer BC, Gaidhane M, Kahaleh M. Clin Gastroenterol and Hepatol 2014 Oct 5 http://www.ncbi.nlm.nih.gov/pubmed/25290534
3 Varadarajulu et al, Equal Efficacy of Endoscopic and Surgical Cystogastrostomy for Pancreatic Pseudocyst Drainage in a Randomized Trial. Gastroenterology 2013; 145:
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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