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This data was sponsored by Norgine and presented at The International Liver Congress on 19-23 April 2017, The Netherlands. IMPRESS is a retrospective observational study that included 11 specialist National Health Service (NHS) centres with 145 patients prescribed rifaximin-α for hepatic encephalopathy. In the study, treatment with rifaximin-α for hepatic encephalopathy was well tolerated.[2] Hepatic encephalopathy is a potentially life-threatening neuropsychiatric condition associated with liver disease.[3] Hepatic encephalopathy affects around 10,000 patients in the UK.[4] Peter Martin, Chief Operating Officer at Norgine said, "The IMPRESS study continues to reinforce the value of rifaximin-α in reducing the recurrence of episodes of hepatic encephalopathy. By recognising hepatic encephalopathy patients and treating them as early as possible with rifaximin-α, healthcare systems will make significant savings." XIFAXAN® 550mg / TARGAXAN® 550mg / TIXTELLER® 550mg (rifaximin-α) is reimbursed through healthcare systems in Australia, England and Wales, Germany, Ireland, Italy, Luxembourg, Netherlands, New Zealand, Norway, Scotland, Sweden and Switzerland. Norgine currently holds marketing rights for XIFAXAN® 550mg (known as TARGAXAN® 550mg in the UK and Belgium) in Australia, Belgium, Denmark, Finland, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden and United Kingdom. 1. Hudson. M. et al. Rifaximin-α is associated with reductions in emergency department resource use in UK patients with hepatic encephalopathy: real world evidence from the IMPRESS study. Abstract ILC2017-RS-1526. The International Liver Congress, 19-23 April 2017; Amsterdam, The Netherlands. 2. Aspinall R. et al. The impact of rifaximin-alpha on NHS hospital resource use in UK patients with hepatic encephalopathy: a retrospective observational study (IMPRESS). Abstract ILC2016-RS-1132. The International Liver Congress, 13-17 April 2016 3. Patidar KR. et al. Covert hepatic encephalopathy is independently associated with poor survival and increased risk of hospitalization. Am J Gastroenterol. 2014. 109. 1757-63. 4. Fleming K M. et al. Incidence and prevalence of cirrhosis in the United Kingdom, 1992-2001: A general population-based study. Journal of Hepatology 49 (2008) 732-738.


1. Hudson. M. et al. Rifaximin-α is associated with reductions in emergency department resource use in UK patients with hepatic encephalopathy: real world evidence from the IMPRESS study. (La rifaximine-α est associée à des réductions de l'usage des ressources des services d'urgence chez les patients britanniques atteints d'encéphalopathie hépatique : données concrètes de l'étude IMPRESS.) Abstract ILC2017-RS-1526. The International Liver Congress, 19-23 avril 2017 ; Amsterdam, Pays-Bas. 2. Aspinall R. et al. The impact of rifaximin-alpha on NHS hospital resource use in UK patients with hepatic encephalopathy: a retrospective observational study (IMPRESS). (L'impact de la rifaximine-alpha sur l'usage des ressources des hôpitaux du NHS chez les patients britanniques atteints d'encéphalopathie hépatique : une étude d'observation rétrospective [IMPRESS].) Abstract ILC2016-RS-1132. The International Liver Congress, 13-17 avril 2016. 3. Patidar KR. et al. Covert hepatic encephalopathy is independently associated with poor survival and increased risk of hospitalization. (L'encéphalopathie hépatique masquée est indépendamment associée à un faible taux de survie et un risque d'hospitalisation accru.) Am J Gastroenterol. 2014. 109. 1757-63. 4. Fleming K M. et al. Incidence and prevalence of cirrhosis in the United Kingdom, 1992-2001: A general population-based study. (Incidence et prévalence de la cirrhose au Royaume-Uni, 1992-2001 : une étude basée sur l'ensemble de la population.) Journal of Hepatology 49 (2008) 732-738.


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global HLA Typing Transplant Market 2017-2021" report to their offering. The global HLA typing transplant market to grow at a CAGR of 9.20% during the period 2017-2021. The report, Global HLA Typing Transplant Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. One trend in the market is new government initiatives for HLA typing. The growing concerns about hepatitis and HIV are leading the government to develop few standards and strategies to reduce the number of communicable diseases through transplantation. Quality measurement in government-introduced programs lead to increased adoption of bone marrow and umbilical cord transplantation. According to the report, one driver in the market is growing incidence of organ failure. The demand for tissue and organs such as bone marrow, heart, liver, kidney, and lungs is very high worldwide. The increasing rate of alcohol consumption, unhealthy lifestyles and food habits, and drug intake are the leading causes of organ failure. In addition, the rise in older adult population results in increased demand for organs for transplantation. According to a combined study conducted by the Department of Internal Medicine, Division of Hepatology, Loyola University Medical Center; Department of Preventive Health Sciences, Stritch School of Medicine, Loyola University Chicago; and Division of Gastroenterology and Hepatology, University of Michigan Health System, in 2015, liver cirrhosis is one of the major factors of death in the US. For more information about this report visit http://www.researchandmarkets.com/research/3rgnwf/global_hla_typing


The global transplantation market to grow at a CAGR of 9.76% during the period 2017-2021. The report, Global Transplantation Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. One trend in market is emergence of 3D bioprinting. 3D bioprinting is a process used to develop tissues in various formats, from micro-scale tissue to standard multi-well tissue, where cell functions and viabilities are preserved within the printed construct. It provides information about cell concentration and diameter of the printed cells. The 3D bioprinters provides information about the cells in kidney, liver, and heart, its metabolic functions. According to the report, one driver in market is increased incidence of organ failure. The demand for tissue and organs such as bone marrow, heart, liver, kidney, and lungs is very high worldwide. Increased alcohol consumption, unhealthy lifestyles and food habits, and drug intake are the leading causes of organ failure. According to a combined study conducted by the Department of Internal Medicine, Division of Hepatology, Loyola University Medical Center; Department of Preventive Health Sciences, Stritch School of Medicine, Loyola University Chicago; and Division of Gastroenterology and Hepatology, University of Michigan Health System, US in 2015, liver cirrhosis is one of the major factors of death in the US. The study found that during 1999-2010 around 633,323 adults were diagnosed with liver cirrhosis. Such statistics indicate the rising demand for liver transplantation as a part of treatment, and accounts for the increased number of liver transplantation cases in the US. Key Topics Covered: PART 01: Executive summary PART 02: Research Methodology PART 03: Introduction PART 04: Market landscape PART 05: Market segmentation by product PART 06: Market segmentation by procedures PART 07: Market segmentation by end-user PART 08: Geographical segmentation PART 09: Decision framework PART 10: Drivers and challenges PART 11: Market trends PART 12: Vendor landscape PART 13: Key vendor analysis PART 14: Appendix For more information about this report visit http://www.researchandmarkets.com/research/rltfnb/global Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-transplantation-market-to-grow-at-a-cagr-of-976-by-2021-witnessing-ma-between-small-specialized-hospitals--tier-1-hospitals---research-and-markets-300456104.html


News Article | May 11, 2017
Site: www.eurekalert.org

(Prague, 11 May, 2017) Experts at the 50th Annual Meeting of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) are today warning that young children who follow a vegan diet without medical and dietary advice carry the risk of a number of nutrient deficiencies, including vitamin B12, calcium, zinc and high quality protein, which can have potentially devastating health effects. Studies have shown that children who follow a vegan diet are leaner and smaller than those children who consume meat or those who have vegetarian diets. "It is difficult to ensure a healthy and balanced vegan diet in young infants, and parents should understand the serious consequences of failing to follow advice regarding supplementation of the diet. The risks of getting it wrong can include irreversible cognitive damage and, in the extreme, death. Our advice is that if parents pursue a vegan diet for their child, they must seek and strictly follow medical and dietary advice to make sure their infant receives adequate nutrition. Both mother and infant should follow advice regarding supplementation" advises Professor Mary Fewtrell, chairman of ESPGHAN's nutrition committee comments: The biggest risk to vegan children is that of vitamin B12 deficiency. Foods derived from animals have been shown to be the only reliable source of vitamin B12 and a deficiency of the vitamin can have devastating effects. Vitamin B12 is essential to the creation of DNA, indispensable for the maintenance of the nervous system, and a lack of it can result in haematological and neurological disorders, causing damage in young children which can be irreversible. Presenting to healthcare professionals at the ESPGHAN conference today, Professor Myriam Van Winckel said: "The more restricted the diet of the child, the greater the risk of deficiency and this is by far highest in vegan children, but the risk does not stop there. Vegan mothers who breastfeed also need to be aware that their children can develop vitamin B12 deficiency between 2 and 12 months because of the lack of reserves in their body at birth, even if the mother is not showing any signs of deficiency herself." Infants on vegan diets are also at risk of protein and calcium malnutrition, a situation made worse because parents can be misled by milk supplements. Rice milk, almond milk and soy milk suggest that they are suitable substitutes for milk, but experts say these should be properly labelled as 'drinks', because their nutritional value is not comparable to milk. Maintaining healthy levels of calcium is important for ensuring lifelong normal bone density, and rickets has been found in toddlers on a calcium-deficient diet consuming large amounts of non-supplemented soy drink. However, unlike vegan diets, varied lacto (ovo) vegetarian and semi-vegetarian diets are generally safe. Although long term follow-up studies are scarce, they do not show a detrimental effect of vegetarian diets in children but instead point to beneficial health outcomes compared to omnivore diets, such as favourable lipid profile, antioxidant status, dietary fiber intake as well as tendencies towards a lower risk of being overweight. For further information, or to speak to an expert, please email media@espghan.org or call James M. Butcher at ESPGHAN's official press agency, Spink, on +44 (0) 1444 811 099. Myriam Van Winckel is head of paediatric gastroenterology at the University Hospital Ghent, Belgium. Her areas of interest include paediatric gastroenterology, hepatology and nutrition and parenteral nutrition and enteral feeding in children. Mary Fewtrell is Professor of Paediatric Nutrition at University College London and specialises in the nutritional programming of bone health, body composition and obesity, human lactation and the design of infant formula, complementary feeding and the duration of exclusive breastfeeding, and infant growth and its association with later-life health. She is also the Chair of ESPGHAN's Nutrition Committee. The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) is a multi-professional organisation whose aim is to promote the health of children with special attention to the gastrointestinal tract, liver and nutritional status, through knowledge creation, the dissemination of science based information, the promotion of best practice in the delivery of care and the provision of high quality education for paediatric gastroenterology, hepatology and nutrition professionals in Europe and beyond. Find out more by visiting http://www. The 50th Annual Meeting of ESPGHAN is taking place from Wednesday 10 to Saturday 13 May 2017, in Prague, Czech Republic. Every year the ESPGHAN meeting attracts the key opinion leaders in the field of Paediatric Gastroenterology, Hepatology and Nutrition from across Europe and all five continents, turning it into the largest conference of its kind worldwide. The Annual Meeting attracts over 4,000 experts from over 100 countries, all operating in the fields of Paediatric Gastroenterology, Hepatology and Nutrition, turning it into the largest conference of its kind worldwide. This year the meeting has received a record number of 839 accepted abstracts. Fewtrell, M., Bronsky, J. et al. Complementary Feeding: A Position Paper by the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Committee on Nutrition. JPGN. 2017. V. 64. No. 1. pp. 119-132. Van Winckel, M. Vegetarian and vegan diets; pros and cons in infants, children and adolescents. Presented at the Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Prague, Czech Republic, 11 May, 2017. Van Winckel, M., Vande Velde, S. et al. Clinical practice: Vegetarian infant and child nutrition. European Journal of Pediatrics. 2011. V. 170. No. 12. pp. 1489-1494.


News Article | May 11, 2017
Site: www.eurekalert.org

Researchers at University of California San Diego School of Medicine, with collaborators across the nation, have determined that magnetic resonance elastography (MRE) can be an accurate, non-invasive tool to identify liver fibrosis in children. Nonalcoholic fatty liver disease (NAFLD) is now the most common cause of chronic liver disease in children, and scarring of the liver, known as fibrosis, is a major determinant of clinical outcomes. Results of the multi-center pediatric study were published online in the May 11 edition of Hepatology. A generation ago, NAFLD was rare in children; it now affects 5 to 8 million children in the U.S. Moreover, NAFLD has become the most common cause of liver transplants in Americans under age 50. Due to the rapid increase in prevalence and severity of the disease, there is a growing interest in emerging imaging technologies that provide doctors with the information needed to care for patients, especially children, in a non-invasive manner. "One of the challenges we face when evaluating a child with NAFLD is to determine the severity of their disease. A major component of that assessment is the staging of the amount of scar tissue seen from a liver biopsy. In MAGNET, we demonstrated that 2D MRE could be used to estimate hepatic stiffness (scarring) in these children," said Jeffrey Schwimmer, MD, paper's co-author and professor of pediatrics at UC San Diego School of Medicine. "We also identified a roadmap to help navigate future use of MRE technology. Ultimately, MRE may be most useful for monitoring the progression or improvement in children with NAFLD." The MAGNET study (MRI Assessment Guiding NAFLD Evaluation and Treatment) was co-led by Schwimmer, director of the Fatty Liver Clinic at Rady Children's Hospital-San Diego, and Claude B. Sirlin, MD, professor of radiology at UC San Diego School of Medicine. MAGNET was the first multi-center study to use non-invasive imaging to assess liver fibrosis in children. "One of the challenging parts of evaluating liver disease in children is determining the numeric cut-off for a positive diagnosis of fibrosis," said Sirlin, who was the study's senior author. "Radiologists and gastroenterologists using MRE should be aware that the interpretation in children may not be the same as in adults. Getting this right has real-world implications." MRE is an imaging tool that measures the stiffness and elasticity of soft solid organs. MRE has emerged from being only a research tool to becoming clinically available on a large percentage of MRI scanners in medical centers across the country. Children in MAGNET were imaged at UC San Diego Health and at Texas Children's Hospital in Houston. The MRE images were independently interpreted at UC San Diego Health and Mayo Clinic in Rochester, Minnesota. Investigators used both manual interpretation and a newly developed automated interpretation method. Schwimmer said that the UC San Diego research team is now exploring the potential of 3D MRE. Further refinement of 2D and 3D MRE, they said, would help close the gap between where each technology is today and where it needs to be to be maximally useful for children. According to the American Liver Foundation, NAFLD is a spectrum of diseases that begins with excess fat builds up in the cells of the liver. As the disease progresses, fibrosis increases, which may become cirrhosis, a permanent form of scarring that can lead to liver failure and need for transplantation. NAFLD affects nearly 25 percent of adults in the U.S., and 5 to 10 percent of all children. In children, the average age of diagnosis is 12. Study co-authors include: Cynthia Behling, Jorge Eduardo Angeles, Melissa Paiz, Janis Durelle, Jonathan Africa, Kimberly P. Newton, Tanya Wolfson, Anthony C. Gamst, Jonathan Hooker, William Haufe, Alexandra Schlein, Gavin Hamilton, and Michael S. Middleton, all from UC San Diego; Elizabeth M. Brunt, Washington University; Joel E. Lavine, Columbia University; Stephanie H. Abrams, Prakash Masand, and Rajesh Krishnamurthy, Texas Children's Hospital ; Kelvin Wong, Houston Methodist Hospital; and Richard L. Ehman, Meng Yin, Kevin J. Glaser, and Bogdan Dzyubak, Mayo Clinic.


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global Transplantation Market 2017-2021" report to their offering. The global transplantation market to grow at a CAGR of 9.76% during the period 2017-2021. The report, Global Transplantation Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. According to the report, one driver in market is increased incidence of organ failure. The demand for tissue and organs such as bone marrow, heart, liver, kidney, and lungs is very high worldwide. Increased alcohol consumption, unhealthy lifestyles and food habits, and drug intake are the leading causes of organ failure. According to a combined study conducted by the Department of Internal Medicine, Division of Hepatology, Loyola University Medical Center; Department of Preventive Health Sciences, Stritch School of Medicine, Loyola University Chicago; and Division of Gastroenterology and Hepatology, University of Michigan Health System, US in 2015, liver cirrhosis is one of the major factors of death in the US. The study found that during 1999-2010 around 633,323 adults were diagnosed with liver cirrhosis. Such statistics indicate the rising demand for liver transplantation as a part of treatment, and accounts for the increased number of liver transplantation cases in the US. For more information about this report visit http://www.researchandmarkets.com/research/xr8f7r/global


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Zakim and Boyer's Hepatology. A Textbook of Liver Disease. Edition No. 7" book to their offering. Get the authoritative, up-to-date information you need on liver disease from the 7th Edition of the most trusted reference worldwide. Covering both basic science and recent clinical developments, this revised edition by Drs. Arun J. Sanyal, Thomas D. Boyer, Norah A. Terrault, and Keith D. Lindor, provides an in-depth, comprehensive look at the pathophysiology, diagnostic, and treatment information related to the liver. More than 1,100 figures and tables, many new and in full color, highlight completely updated content throughout. Section X. Liver Affected by Other Conditions or Diseases For more information about this book visit http://www.researchandmarkets.com/research/4c49c8/zakim_and_boyers


REDWOOD CITY, Calif., May 9, 2017 /PRNewswire/ -- C2 Therapeutics marked Digestive Disease Week by releasing the results of clinical studies that help further validate the utility of the C2 CryoBalloon® Ablation System (CbAS) for ablation of Barrett's esophagus.i These include studies that suggest a shorter physician learning curve with CbAS than for radiofrequency ablation (RFA) therapy and less pain two days post-procedure than with RFA. Further studies demonstrate potential for CbAS in ablation of gastric antral vascular ectasia (GAVE) and esophageal squamous cell neoplasia (ESCN). The CbAS is similar to RFA in being deployed with an endoscopic catheter but uses extreme cold instead of heat to destroy diseased tissue in the esophagus. In a procedure known as cryoballoon ablation, nitrous oxide (N 0) cryogen is delivered through a handheld controller in combination with a self-sizing balloon catheter that is inserted into the working channel of a 3.7 mm therapeutic endoscope. The CbAS has been used in nearly 900 procedures to date. The synopses of the study results released for Digestive Disease Week are: Physician Learning Curve. Studies show that physicians must perform about 30 RFA procedures to overcome the effect of learning curve on treatment outcomes.1 This study aimed to determine the learning threshold for ablation of Barrett's esophagus with the CbAS. The researchers analyzed prospectively collected cryoablation procedure data from patients with neoplastic Barrett's esophagus treated at a single academic institution. They concluded that the learning curve effect for CbAS is reached at about 18 cases, after which efficiency plateaus. Patient Experience. Two studies in the Netherlands2 compared post-procedural pain in 79 Barrett's esophagus patients treated with RFA patients and 20 treated with focal cryoballoon ablation. In both studies, all visible Barrett's esophagus was treated, including circumferential treatment of the gastroesophageal junction. Pain was assessed immediately after the procedures and by telephone on Day 2. Patients were asked to apply pain scores from zero (no pain) to 10 (worst pain possible). Immediately after the procedure, 53% of cryoballoon ablation patients reported severe pain (score greater than 3), versus 24% of RFA patients. However, on Day 2, 46% of RFA patients reported severe pain, versus 18% of cryoballoon ablation patients. "This could suggest a shortened pain course after cryoballoon ablation compared with RFA," said the principal investigator Prof. Bas Weusten, Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands. Treatment for ESCN. Esophageal squamous cell cancer arises from esophageal squamous cell neoplasia (ESCN) and is highly lethal. A multi-site study3 assessed the safety and efficacy of focal cryoballoon ablation for eradicating ESCN. Forty-two patients (98%) were successfully treated. Thirty-five of 40 patients (88%) had complete eradication of unstained lesions (USL) upon a single treatment session; five patients (12%) with persistent USL were successfully re-treated. Three developed superficial self-limited mucosal laceration upon balloon inflation; two of these were successfully treated three months later and one did not return. Dr. Gui-Qi Wang, Department of Endoscopy, Cancer Institute and Hospital Chinese Academy of Medical Sciences in Beijing, China stated, "Although longer-term follow-up data is pending, early results of our multicenter study suggest that focal cryoballoon ablation is safe, well-tolerated and highly effective in inducing complete endoscopic and histologic response." Treatment for GAVE. GAVE is an uncommon cause of upper gastrointestinal bleeding. Endoscopic management has been mainly thermoablative, but balloon cryoablation is emerging as an alternative. This multi-center study4 reviewed data from 10 patients with refractory GAVE who were treated with balloon cryotherapy. These were patients who continued to receive treatment for GAVE despite prior non-cryoballoon therapy. Each patient received one to four cryoballoon treatments (median two). Technical success was achieved in all patients. Follow-up endoscopy showed improvement in eight patients; one patient showed no improvement in the three months post-cryotherapy. No adverse events were reported. "Cryoballoon therapy is a feasible and safe modality that can be used to treat GAVE," reports Dr. Amrita Sethi, Division of Digestive and Liver Disease, Columbia University Medical Center, New York, NY. "Further studies are needed to evaluate long-term outcomes for this modality and to compare results to standard therapies." Swipe Cryoballoon Ablation Technique. Ablation devices for dysplastic Barrett's esophagus are effective, but none offer the attributes for widespread adoption because of length of procedure time and ease of use. Other factors include side effects and lack of predictability of ablation depth. This multi-center study5 evaluated the safety, feasibility and dose response of a novel swipe balloon catheter developed by C2 Therapeutics (to be marketed as the C2 CryoBalloon® 90 Ablation System), which delivers 3 cm of ablation in less than 60 seconds. The technique was tested in domestic swine and six human patients. The swipe technique delivered uniform and predictable ablation with mucosal and submucosal necrosis in animal and human esophagus. All the animals tolerated the ablations without difficulty and were able to eat and gain weight afterward. The human patients also tolerated the procedure without adverse events. Investigators concluded that because of its ease of use, the device merits further clinical study in treating dysplastic Barrett's esophagus. "These studies reinforce C2 Therapeutics' commitment to improving treatment for patients affected by Barrett's esophagus and other diseases of the gastrointestinal system," said Peter Garcia-Meza, President and CEO. "We continue to develop new design configurations to treat unmet needs in patients with diverse anatomy and disease characteristics. We sincerely appreciate the dedication and support of our collaborating study investigators and participating trial centers." Barrett's esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett's esophagus), putting patients at greater risk of developing cancer of the esophagus. Founded in 2007 and headquartered in Redwood City, California, C2 Therapeutics developed the C2 CryoBalloon® Ablation System for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia. Acquired by PENTAX Medical – a division of HOYA Group – in January 2017, C2 Therapeutics continues to innovate and enhance its C2 CryoBalloon® Ablation System as a new standard for simplicity in the eradication of esophageal disease. For more information about C2 Therapeutics, please visit www.c2therapeutics.com. 1 George Kunnackal John, et al, Cryoballoon Ablation for Barrett's Esophagus: A Prospective Single Operator Learning Curve and Time-Efficiency Study, TU1170, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 2 Sanne N. van Munster, et al, Post-Procedure Pain Associated with Endoscopic Ablation Therapy of Barrett's Esophagus: Post-Hoc Comparison Between Radiofrequency Ablation and Cryoballoon Ablation, TU1186, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 3 Yan Ke, et al, Safety and Efficacy of Endoscopic Focal Cryoballoon Ablation for the Treatment of Esophageal Squamous Cell Intraepithelial Neoplasia, M01997, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 4 Anish Patel, et al, Endoscopic Management of Refractory Gastric Antral Vascular Ectasia (GAVE) with Cryoballoon Therapy: A Case Series, MO1986, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 5 Brian E. Louie, et al, Evaluation of a Novel Swipe Cryoballoon Ablation System in Bench, Porcine, and Human Esophagus, MO2010, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. i C2 CryoBalloon Focal Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia.


The CbAS is similar to RFA in being deployed with an endoscopic catheter but uses extreme cold instead of heat to destroy diseased tissue in the esophagus. In a procedure known as cryoballoon ablation, nitrous oxide (N 0) cryogen is delivered through a handheld controller in combination with a self-sizing balloon catheter that is inserted into the working channel of a 3.7 mm therapeutic endoscope. The CbAS has been used in nearly 900 procedures to date. The synopses of the study results released for Digestive Disease Week are: Physician Learning Curve. Studies show that physicians must perform about 30 RFA procedures to overcome the effect of learning curve on treatment outcomes.1 This study aimed to determine the learning threshold for ablation of Barrett's esophagus with the CbAS. The researchers analyzed prospectively collected cryoablation procedure data from patients with neoplastic Barrett's esophagus treated at a single academic institution. They concluded that the learning curve effect for CbAS is reached at about 18 cases, after which efficiency plateaus. Patient Experience. Two studies in the Netherlands2 compared post-procedural pain in 79 Barrett's esophagus patients treated with RFA patients and 20 treated with focal cryoballoon ablation. In both studies, all visible Barrett's esophagus was treated, including circumferential treatment of the gastroesophageal junction. Pain was assessed immediately after the procedures and by telephone on Day 2. Patients were asked to apply pain scores from zero (no pain) to 10 (worst pain possible). Immediately after the procedure, 53% of cryoballoon ablation patients reported severe pain (score greater than 3), versus 24% of RFA patients. However, on Day 2, 46% of RFA patients reported severe pain, versus 18% of cryoballoon ablation patients. "This could suggest a shortened pain course after cryoballoon ablation compared with RFA," said the principal investigator Prof. Bas Weusten, Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands. Treatment for ESCN. Esophageal squamous cell cancer arises from esophageal squamous cell neoplasia (ESCN) and is highly lethal. A multi-site study3 assessed the safety and efficacy of focal cryoballoon ablation for eradicating ESCN. Forty-two patients (98%) were successfully treated. Thirty-five of 40 patients (88%) had complete eradication of unstained lesions (USL) upon a single treatment session; five patients (12%) with persistent USL were successfully re-treated. Three developed superficial self-limited mucosal laceration upon balloon inflation; two of these were successfully treated three months later and one did not return. Dr. Gui-Qi Wang, Department of Endoscopy, Cancer Institute and Hospital Chinese Academy of Medical Sciences in Beijing, China stated, "Although longer-term follow-up data is pending, early results of our multicenter study suggest that focal cryoballoon ablation is safe, well-tolerated and highly effective in inducing complete endoscopic and histologic response." Treatment for GAVE. GAVE is an uncommon cause of upper gastrointestinal bleeding. Endoscopic management has been mainly thermoablative, but balloon cryoablation is emerging as an alternative. This multi-center study4 reviewed data from 10 patients with refractory GAVE who were treated with balloon cryotherapy. These were patients who continued to receive treatment for GAVE despite prior non-cryoballoon therapy. Each patient received one to four cryoballoon treatments (median two). Technical success was achieved in all patients. Follow-up endoscopy showed improvement in eight patients; one patient showed no improvement in the three months post-cryotherapy. No adverse events were reported. "Cryoballoon therapy is a feasible and safe modality that can be used to treat GAVE," reports Dr. Amrita Sethi, Division of Digestive and Liver Disease, Columbia University Medical Center, New York, NY. "Further studies are needed to evaluate long-term outcomes for this modality and to compare results to standard therapies." Swipe Cryoballoon Ablation Technique. Ablation devices for dysplastic Barrett's esophagus are effective, but none offer the attributes for widespread adoption because of length of procedure time and ease of use. Other factors include side effects and lack of predictability of ablation depth. This multi-center study5 evaluated the safety, feasibility and dose response of a novel swipe balloon catheter developed by C2 Therapeutics (to be marketed as the C2 CryoBalloon® 90 Ablation System), which delivers 3 cm of ablation in less than 60 seconds. The technique was tested in domestic swine and six human patients. The swipe technique delivered uniform and predictable ablation with mucosal and submucosal necrosis in animal and human esophagus. All the animals tolerated the ablations without difficulty and were able to eat and gain weight afterward. The human patients also tolerated the procedure without adverse events. Investigators concluded that because of its ease of use, the device merits further clinical study in treating dysplastic Barrett's esophagus. "These studies reinforce C2 Therapeutics' commitment to improving treatment for patients affected by Barrett's esophagus and other diseases of the gastrointestinal system," said Peter Garcia-Meza, President and CEO. "We continue to develop new design configurations to treat unmet needs in patients with diverse anatomy and disease characteristics. We sincerely appreciate the dedication and support of our collaborating study investigators and participating trial centers." Barrett's esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett's esophagus), putting patients at greater risk of developing cancer of the esophagus. Founded in 2007 and headquartered in Redwood City, California, C2 Therapeutics developed the C2 CryoBalloon® Ablation System for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia. Acquired by PENTAX Medical – a division of HOYA Group – in January 2017, C2 Therapeutics continues to innovate and enhance its C2 CryoBalloon® Ablation System as a new standard for simplicity in the eradication of esophageal disease. For more information about C2 Therapeutics, please visit www.c2therapeutics.com. 1 George Kunnackal John, et al, Cryoballoon Ablation for Barrett's Esophagus: A Prospective Single Operator Learning Curve and Time-Efficiency Study, TU1170, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 2 Sanne N. van Munster, et al, Post-Procedure Pain Associated with Endoscopic Ablation Therapy of Barrett's Esophagus: Post-Hoc Comparison Between Radiofrequency Ablation and Cryoballoon Ablation, TU1186, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 3 Yan Ke, et al, Safety and Efficacy of Endoscopic Focal Cryoballoon Ablation for the Treatment of Esophageal Squamous Cell Intraepithelial Neoplasia, M01997, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 4 Anish Patel, et al, Endoscopic Management of Refractory Gastric Antral Vascular Ectasia (GAVE) with Cryoballoon Therapy: A Case Series, MO1986, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 5 Brian E. Louie, et al, Evaluation of a Novel Swipe Cryoballoon Ablation System in Bench, Porcine, and Human Esophagus, MO2010, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. i C2 CryoBalloon Focal Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia.

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