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1 SPRING 2011 GLOBAL EDITION Advances in Interventional Endoscopy Clinical Updates Resolution Clip page 1 Expect Needle for EUS FNA pages 2 3 SpyGlass Direct Visualization System pages 4 5 WallFlex Family of Stents pages 6 9 TM Other News back cover New Product Updates back cover Expect EUS Needle Extractor Pro Retrieval Balloon Laser for SpyGlass System TM TM Boston Scientific Ranked #1 in Reimbursement Boston Scientific Recognized for Customer Service

2 A WORD FROM THE PRESIDENT Dave Pierce Senior Vice President, Boston Scientific President, Endoscopy Division Many of you know Mike Phalen and his passion for the field of gastroenterology which resulted in the introduction of many innovative technologies that are now standard of care in endoscopy suites around the world. In January, Mike was named President of Boston Scientific s International business, a promotion that recognized his leadership as well as the success of the Endoscopy Division. I am honored to take on the challenge of leading Boston Scientific s Endoscopy business into the future. I have worked at Boston Scientific for 20 years, and in the Endoscopy Division for 10 of those years. I m very excited about our next wave of technological advances and the clinical differentiation that you ve come to expect from us. I m equally proud of the increasing value we bring to healthcare institutions in these economically challenging times. As the dynamics of healthcare change, you want to get the most from your relationship with suppliers such as ourselves. Our value-added programs provide flexibility for a variety of customer needs. Business practices built on integrity and healthcare compliance strive to deliver fairness and accountability. Our highly regarded educational services enable hands-on learning locally while educational grants help advance the practice of gastroenterology broadly. To share knowledge globally, we re embarking on new web-based learning initiatives. Our investment in employees as well as service programs has further strengthened our culture of quality and customer support. That culture has earned Boston Scientific top marks in independent surveys. J.D. Power and Associates recognized our company for delivering outstanding customer experiences through our call center operations six years in a row. In a survey of 200 decision-making hospital executives, L.E.K. Consulting reported Boston Scientific as the number one medical device company for healthcare reimbursement support (see back cover). Our commitment to physicians, hospitals, and patients is value creating to provide what you want from a market leader. No matter what changes, our purpose remains the same to improve the quality of life for patients. In this issue, we highlight physician stories as they improve quality of life around the world with our new Expect TM Endoscopic Ultrasound Needle, Resolution Clip, SpyGlass Direct Visualization System and our WallFlex family of stents. New products and other news are on the back cover. Reach out and tell us your story. Dave Pierce, Senior Vice President and President, Endoscopy Division, joined Boston Scientific in 1991 as a Territory Manager before assuming various management-level positions of increasing responsibility. Most recently, he was Endoscopy Vice President of Global Marketing. Prior to Boston Scientific, Dave worked for Airborne Express and served as a Captain in the United States Army. Dave holds an M.B.A. from Boston University.

3 Resolution clip UGI Case Hemoclipping of Polypectomy Sites Case presented by: Dennis M. Jensen, MD, CURE DDRC UCLA & VA, Medical Centers, and David Geffen School of Medicine at UCLA 52-year-old white male with history more than 10 years ago of both liver & renal transplants. Both organs are failing. He is awaiting retransplant of both. He is on hemodialysis and lives in a neighboring state. While hospitalized for reevaluation he developed hematemisis and melena. His hemoglobin (Hgb) was 11, platelets 27,000, INR 1.6. and creatinine is 5.0. Because of the concern of malignancy while on long term immunosuppressants, a CT scan was done. It revealed an antral polyp & thickened antral folds which may represent lymphoma. He also has diabetes mellitus, weight loss, anemia, liver & renal failure. He had an elective endoscopy. Why is it important to clip post polypectomy? This patient has severe intrinsic coagulopathies, (high INR & very low platelet count) not reversible and related to his end stage renal disease and liver failure. He has a very high risk of delayed bleeding after gastric polypectomies. Closure of the post-polypectomy induced ulcer (PPIU) in such patients may significantly reduce delayed bleeding and accelerate PPIU healing. Figure 1A Figure 2A Figure 3A Figure 4A How do you know where to start and when you are done? Start at edge of PPIU and zipper closed with clips. PPIU closure is the goal and control of bleeding, if there is any. Figure 1B Multiple, multilobulated pre-pyloric sessile polyps were found. These appeared benign. These were friable and oozed with water irrigation or contact (Figures 1-2). A rotatable snare was utilized for piecemeal polypectomy after pre-injection (to raise the polyps off the submucosa with a saline, methylene blue mixture (Figures 3-4)). The blue submucosa is evident after such treatment (Figure 4). Figure 5A Figure 2B Figure 6A Figure 3B Figure 7A Figure 4B Figure 8A How do you measure success? No further rebleeding during followup and if feasible, documentation of post-polypectomy induced ulcer (PPIU) healing. How common are these cases? For the stomach, polyps are less common in US populations then polyps in the colon. However, in aging populations or those with transplantation and organ failure, coagulopathies are very common and delayed bleeding is of concern. Figure 5B Figure 6B Figure 7B Figure 8B Hemoclips (Resolution Clips) were utilized to zipper the edges together (Figures 5-8). This required multiple hemoclips (HC) on each post-polypectomy induced ulcer (PPIU) to close them. The histopathology was benign (hyperplastic polyps without dysplasia or vascular ectasia). This patient received oral proton pump inhibitors (PPI s) for 48 hours before the EGD and polypectomies. He continued on PPI s twice a day for 5 weeks and did not have rebleeding during 60 days of GI follow-up. This is particularly noteworthy given his severe intrinsic coagulopathies. He awaits both liver and kidney transplantations. Q&A with Dr. JENSEN access 1

4 EXPECT TM EndoscoPIC ultrasound aspiration needle Adenocarcinoma Confirmed by Fna on a Patient with Chronic Pancreatitis Case presented by: Professor Pierre H. Deprez (pictured), Ivan Borbath, MD, Christine Galant, MD and Professor Jean-François Gigot Cliniques Universitaires Saint-Luc Université Catholique de Louvain Brussels, Belgium A 46-year-old female patient with a long history of chronic calcifying pancreatitis had developed large liver abscesses related to biliary stricture and angiocholitis. Her septic condition improved with multiple internal and external biliary and liver drainage (Fig 1) but a CT scan showed appearance of a preaortic infiltrate (Fig 2) with involvement of the left adrenal gland suggestive of neoplasia. EUS confirmed a hypoechoic, poorly defined structure surrounding the celiac trunk, with enlarged lymph nodes and a tumoral adrenal gland. FNA was performed with the new Expect 22 gauge needle with two passes in the infiltrate (Fig 3), two passes in the adrenal gland and one pass in a small lymph node (Fig 4). Cytopathological analysis of the specimen clearly showed the presence of a poorly differentiated adenocarcinoma in the infiltrate and the adrenal gland (Fig 5). Our first impression using the new Expect Needle was very positive. It had excellent sharpness, allowing puncture even in difficult scope positions and in hard structures. Its excellent visibility gave a precise view of the needle tract and tip, even in distant and small lesions, and as demonstrated in this case, the feasibility of multiple passes. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 2 access

5 EXPECT TM Endoscopic ultrasound aspiration needle EUS FNA of a Pancreatic Genu Lesion: Sharpness Helps A 45-year-old patient presented with obstructive jaundice and a pancreatic head mass. EUS showed a 3cm lesion at the genu. Attempts to biopsy the lesion in the short position were impossible due the fact that the scope kept slipping into the stomach. Therefore, biopsy from the duodenal bulb with the scope in a long position was the only option. Anand V. Sahai, MD, MSc (Epid), FRCPC St. Luc Hospital, Montreal, Quebec Canada A 22 gauge Expect Needle was deployed. The needle tip punctured the intestinal wall and entered the lesion very easily, suggesting the sharpness of the tip was particularly helpful. In the majority of cases, EUS FNA procedures can be performed with the scope in a short (straight) position. However, lesions in the genu region can be difficult to biopsy in a short position because the scope must be pulled back so far that it tends to slip into the stomach before the lesion can be biopsied. In these cases, the lesions can be seen easily with a stable, long scope position in the bulb. However, due to the tortuosity and tip angulation of the scope in this position (and possibly lesion hardness), pancreatic head mass biopsies from the bulb can be challenging. In this case, the sharpness of the Expect Needle appears to make FNA of such lesions easier. A Challenging Trans-Duodenal FNA at EUS: Better Maneuverability Made a Difference A 53-year-old patient presented with right upper quadrant pain and obstructive jaundice. A CT of the abdomen revealed a mass in the hilum of the liver and an indeterminate lesion in the left lobe of the liver. Shyam Varadarajulu, MD Director of Endoscopy Basil I. Hirschowitz Endoscopic Center of Excellence University of Alabama at Birmingham At EUS, a gallbladder mass measuring 3 x 2cm was seen near the liver hilum. A 25 gauge Expect Needle was passed via the trans-duodenal route and adequate specimen was procured on pass one. Onsite cytopathology confirmed this to be carcinoma. As the liver lesion was indeterminate on CT imaging, an EUS-guided FNA of the liver mass was undertaken. At EUS, the liver mass measured 22 x 18mm, was hypoechoic in appearance, and the lesion was located very tangential to the echoendoscope. A 22 gauge Expect Needle was deployed at right angle to the lesion and adequate tissue was procured on pass one. Onsite cytopathology confirmed the lesion to be a metastatic cancer. Performing trans-duodenal FNAs at EUS can be technically challenging. In this case, there was no technical difficulty either with trans-duodenal needle deployment or when the Expect Needle was positioned at 90 degrees to the target lesion in the liver. The needle passed smoothly on both occasions and there was minimal deformation when removed from the scope. It appears that Cobalt Chromium, a feature in the construction of the Expect Needle, may contribute to its better maneuverability and low needle deformation. access 3

6 SpyGlass Direct VisualiZation System The SpyGlass Direct Visualization System was launched worldwide in July, This innovative system has become a widely accepted tool for diagnostic and therapeutic procedures in the pancreatico-biliary system. Some product milestones to date include: Installed in over 700 medical facilities worldwide Used in more than 24,000 patient procedures worldwide Supported by published clinical data in more than 60 abstracts and articles in peer-reviewed medical journals Laser Lithotripsy on a Large Stone Using the SpyGlass Direct Visualization System Case presented by: Sandeep N. Patel, DO Assistant Professor of Medicine University of Texas Health Science Center San Antonio, Texas PATIENT HISTORY A 60-year-old patient was referred to our center for a stone extraction after undergoing two failed ERCPs that included a sphincterotomy, attempted balloon and basket extraction and mechanical lithotripsy. The patient had a large hard stone in a small duct above an area of stenosis. We decided to use the SpyGlass System with laser lithotripsy to fragment the stone and extract the fragments out of the bile duct. PROCEDURE The papilla was cannulated with a sphincterotome and a.035 guidewire. A sphincterotomy was performed to facilitate easy SpyGlass cannulation, create an open circuit for aggressive water irrigation, and facilitate extraction of the stone or any additional fragments. Once the distal bile duct was accessed, the SpyScope Catheter was advanced until the stone was visualized. The laser probe was passed into the duct, and several bursts of energy were applied while keeping the probe and the stone in complete visualization. We could see that the stone was fragmenting and we observed no ductal trauma or bleeding. CONCLUSION Historically, patients with difficult stones that did not respond to a sphincterotomy, sphincteroplasty, balloon basket extraction, or mechanical lithotripsy have gone to surgery. With the advances in cholangioscopy, namely the SpyGlass System, we can now deliver laser lithotripsy, fragment and extract stones, and confirm total ductal clearance through direct visualization. By using the SpyGlass System, we can often avoid surgery. In this case, we were able to use the SpyGlass System and laser lithotripsy to fragment and extract the stone, confirm complete clearance of the duct, spare this patient any further endoscopies and, most importantly, a visit to the operating room. 4 access

7 SpyGlass Direct VisualiZation System During an ERCP, a cholangiogram confirmed the presence of an indeterminant stricture in the mid CBD, it was decided to evaluate the stricture with the SpyGlass Direct Visualization System. The stricture appeared benign with smooth narrowings, while the mid segment looked fibrotic and inflamed, the intrahepatic ducts had a normal appearance. Therefore, the stricture will be managed with dilatation as necessary. Paul Edwards, MD Gastroenterologist Liverpool Hospital Sydney, Australia The visual findings were so dramatic, we decided not to stent, and these findings saved the patient an operation. With the utilization of the SpyGlass System, the awareness of cholangioscopy as a modality has been raised. It is my opinion that this is a procedure that is here to stay. The SpyGlass System can be used to guide visualization and accessory devices throughout the entire pancreatico-biliary system, enabling physicians to diagnose and treat pancreatic cancer or pre-cancerous tissues. Dimitris Xinopoulos, MD Director, Department of Gastroenterology St. Savvas Anticancer Hospital of Athens, Greece A 76-year-old patient was referred to our center suffering from painless jaundice due to a sub hilar, mid section CBD stenosis. The stenosis was viewed under an MRCP scan as a cholangiocarcinoma and the patient was scheduled for an ERCP. A cholangioscopy using the SpyGlass Direct Visualization System, followed by biopsy tissue sample examination, revealed a thickened normal mucosa appearance caused eventually from post-cholecystectomy fibrosis. The SpyGlass System is a unique diagnostic cholangioscopy tool for direct visualization and tissue sampling of indeterminate extra hepatic biliary stenosis. Direct biliary visualization with the SpyGlass System prevented an unneeded surgical approach. One year later, the patient is in excellent condition undergoing repetitive plastic stent therapy. Takao Itoi, MD, PhD. Tokyo Medical University Hospital, Tokyo, Japan A 74-year-old patient was referred to our hospital with acute cholangitis caused by a large bile duct stone. Mechanical lithotripsy failed because the stone could not be captured in the basket. Electrohydraulic lithotripsy with the SpyGlass System was performed under saline solution irrigation. The stone fragments were then removed using mechanical lithotripsy, a standard basket, and balloon extraction techniques without any adverse effects. Direct biliary visualization with the SpyGlass System revealed complete duct clearance. In my opinion, the SpyGlass System is a promising diagnostic and therapeutic tool for the management of difficult bile duct stones. Dr. Maydeo has been selected to present a video of the SpyGlass System at the first World Cup of Endoscopy, organized by the American Society for Gastrointestinal Endoscopy (AGSE) at its annual Digestive Disease Week (DDW ) in Chicago this May. Dr. Maydeo is one of 11 physicians chosen to present their innovations. Amit Maydeo, MD Institute of Advanced Endoscopy Mumbai, India After launching SpyGlass for the first time in India two years back in our Institute, I have had the pleasure of using this wonderful device in established and advanced procedures, he said. In addition to diagnostic cholangio-pancreatoscopy, SpyGlass has enhanced our capability to treat otherwise untreatable bile duct stones. The main features of the SpyGlass System which are uniquely important for our country are its ease of use, durability and cost-effectiveness. Surely it has been a boon to the specialist dealing with advanced biliary and pancreatic work. access 5

8 WallFlex Enteral Stents Cases presented by: Rajeev Jain, MD Chief of Gastroenterology Texas Health Dallas Dallas, TX Colonic Decompression as an Alternative to Surgery PatIent HISTORY An 80-year-old man was diagnosed with rectal adenocarcinoma 2 years earlier for which he underwent abdominal perineal resection with end colostomy. He was treated with adjuvant chemoradiation. He developed recurrent metastatic rectal cancer and presented with a colonic obstruction manifested by nausea, vomiting, abdominal distension and no passage of gas or stool per ostomy. CT scan demonstrated a colonic obstruction 20 cm proximal to his ostomy. Duodenal Decompression as an Alternative to Gastrojejunostomy PatIENT HISTORY A 79-year-old woman with metastatic pancreatic adenocarcinoma presented to the emergency department with nausea and vomiting. Imaging demonstrated a distended stomach. After undergoing nasogastric tube decompression, an endoscopy showed a duodenal stricture from her pancreatic cancer, which was confirmed by an upper GI series. She was offered the options of palliative surgical decompression or duodenal stent placement. Given her overall poor condition, she elected to proceed with enteral stent placement. Colonic Stricture Colonic Stricture After Stent Duodenal Stricture Duodenal Stricture After Stent PROCEDURE A therapeutic endoscope was inserted into his ostomy and a malignant appearing obstruction was found 20 cm proximal to the ostomy. Under fluoroscopy, a catheter was advanced into the stricture and contrast was injected to delineate the stricture. A (0.89 mm) Jagwire Guidewire was advanced across the stricture under fluoroscopic guidance. A 25 mm x 90 mm WallFlex Colonic Stent was successfully deployed. POST PROCEDUre The obstructive symptoms resolved and the patient was able to consume a liquid diet on the same day as the stent placement. Also, he was discharged to home hospice shortly thereafter thus limiting his stay in the hospital and maximizing his time at home with family. PROCEDURE Using a therapeutic endoscope, a catheter was advanced into the proximal portion of the duodenal stricture. Contrast was injected through the catheter to delineate the stricture under fluoroscopy. A (0.89mm) Jagwire Guidewire was advanced across the stricture under fluoroscopic guidance. A 22 x 90mm WallFlex Duodenal Enteral Stent was successfully deployed. POST PROCEDURE The patient no longer experienced nausea and vomiting. She was able to tolerate a liquid diet and was discharged home. DISCUSSION Palliation of obstructions with endoscopic stent placement is less invasive, with shorter hospital stays, and earlier resumption of oral intake in comparison to surgical decompressions. 6 access

9 WallFlex Biliary RX Fully Covered Stent Treating a Malignant Stenosis of the CBD using the WallFlex Biliary RX Fully Covered Stent Case presented by: Duowu Zou, MD Department of Gastroenterology Changhai Hospital Second Military Medical University Shanghai, China Patient History A 76-year-old man presented with abdominal distention and jaundice, with a bilirubin reading of 312 mmol/l, and CA19-9 of more than A CT scan showed a soft tissue shadow on the head of the pancreas with an enlarged bile duct. An MRCP showed a stenosis on the lower part of bile duct with enlarged intra- and extra-hepatic ducts. A diagnosis of carcinoma at the head of the pancreas and bile duct obstruction was confirmed. The patient refused surgery, and drainage of the bile duct was selected to relieve the obstruction. Procedure An Autotome TM RX Sphincterotome was deployed through the duodenoscope and inserted into the bile duct under the guidance of a Hydra Jagwire Guidewire. The radiography image showed that there was a stricture at the lower part of the bile duct, which was about 4cm in length. Following an exchange, an 10mm x 80mm fully covered WallFlex Biliary RX Stent was inserted into the common bile duct. Post placement, a large quantity of bile poured into the intestine. The stent expanded very well after deployment, with excellent visibility under X-ray and good tissue compliance. Technology Update In my opinion, metal stents are the most effective method for the treatment of a malignant stenosis in the common bile duct where surgery is not an option. They may decrease the frequency of reintervention, reduce medical costs, and increase the survival rate of patients. The WallFlex Biliary RX Stent is designed for rapid exchange, and it is easy to use. The platinum core and the Nitinol outer skin provide the extremely strong contrast visibility for the stent, and the enhanced ratio of overall length versus radiopacity increases the handleability of surgery. The radial expansionary force makes the stent resist crumpling in case of restenosis. The excellent flexibility of the stent may be helpful when it is deployed in tortuous anatomy, which may also maintain the clearance and physiological compliance of the inner space of the stent. The closed loop design on both ends of the stent decreases the potential for injury to the surrounding tissue. The flared design of the stent allows it to be easily observed and accurately placed. In summary, the WallFlex Biliary RX Stent is easy to deliver, deploys rapidly, and complies with the anatomy, which is a good choice for the treatment of a malignant stenosis in the bile duct. access 7

10 WallFlex Esophageal Fully Covered Stent WallFlex Esophageal Fully Covered Stent as Bridge-to-Surgery Case presented by: Sean E. McGarr, DO Kennebec Gastrointestinal Associates, Maine General Medical Center Director of Gastrointestinal Oncology, Harold Alfond Center for Cancer Care Cancer Physician Liaison for the Commission on Cancer Augusta, Maine USA Patient History A 63-yr-old male with malignant esophageal adenocarcinoma presented with dysphagia and had heartburn for several weeks. Based on EUS and CT examination, the patient was staged T2N0M0 and therefore a potential candidate for surgical resection. I explained the potential advantages of placing a fully covered, self expanding nitinol stent over a peg tube as preparation for surgery. Procedure A medium-sized mass with stigmata of recent bleeding was found in the lower third of the esophagus, in the gastroesophageal junction and in the cardia. The mass was completely obstructing and circumferential. The stricture was cannulated with a 260cm Dreamwire Guidewire and the scope was passed through the stricture and retroflexed to view the tumor extending into the cardia. A 18mm x 123mm WallFlex Esophageal Fully Covered Stent was passed over the wire and deployed under fluoroscopic guidance. Successful stent placement was achieved without the need for dilation due to the slim, 18.5fr diameter of the delivery catheter. Post Procedure Clinical success was achieved as the patient was discharged same day. The goal was for the patient to progress to surgery within three weeks. Discussion In my practice I encourage patients who may be resectable but have tumor invading their esophagus causing the inability to swallow to have a stent placed. As a patient loses the ability to swallow, their risk of aspiration increases. The WallFlex Esophageal Fully Covered Stent has the potential to improve their quality of life. 8 access

11 The following case represents an indication that is not cleared for use in the United States. INTERNATIONAL EXPERIENCE WallFlex TM Biliary RX Fully Covered Stent Case presented by: Arthur John Kaffes, MD Specialist Gastroenterologist Royal Prince Alfred Hospital Sydney, Australia Patient History & Assessment The patient is a 62-year-old man with a long history of excessive alcohol consumption. He was diagnosed with chronic pancreatitis some years ago with calcification of his pancreas and the development of pseudocysts. The pseudocysts were treated surgically. In recent months, he has developed worsening pain of chronic pancreatitis and further investigations have shown dilated intrahepatic ducts and obstructive liver tests. No focal pancreatic masses have been seen and his pancreatic tumour markers are normal. An ERCP with the placement of a fully covered biliary metal stent was scheduled. Procedure At an initial ERCP, a long distal biliary stricture was observed (see Figure 1) and a temporary 10 French, 10cm plastic biliary stent was placed for the relief of the patient s pain. A month later at a further ERCP, a decision was made to exchange the plastic stent for a fully covered removable metal stent. A (0.89mm) Hydra Jagwire Guidewire was passed through the duodenoscope into the common bile duct and a 10mm x 80mm Fully Covered WallFlex Biliary RX Stent was placed. The stent was deployed without difficulty. Repeat endoscopic examination revealed excellent positioning of the proximal edge of the stent as shown in Figures 5 and 6. Results/ Patient Outcome Post procedure, the patient tolerated the procedure well, although some pain was experienced. Blood tests were negative for pancreatitis or cholangitis. The pain resolved by the following morning and he was discharged feeling very well. The patient follow-up plan is to leave the stent in situ for about 6 months, then remove it and reassess the stricture for resolution. Summary/ Discussion Fully covered metal biliary stents are a good option for the treatment of benign biliary strictures. The WallFlex Stent has a thin 8.5Fr (2.83mm) and flexible delivery catheter that allows for easy insertion. In addition, the Platinol TM wire construction gives a high level of flexibility incorporating an integrated retrieval loop designed for acute removability up to 12 months post placement. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 The WallFlex Biliary RX Fully Covered Stent is not cleared for use in the United States for benign biliary strictures, but has CE Mark approval for the treatment of benign biliary strictures and repositioning up to 12 months after initial placement. Please check availability of the product with your local Boston Scientific representative. Figure 6 access 9

12 ACCESS UPDATES Product Portfolio Expansion The new Expect TM Endoscopic Ultrasound Needle is now available worldwide. The Expect Needle features a Cobalt- Chromium needle assembly designed for superior needle penetration, improved pushability and kink resistance, and durability. A highly visible echogenic pattern and sharp needle grind are designed to provide precise guidance to the target site and improved penetration to the lesion. Boston Scientific Ranked #1 in Reimbursement A recent survey of nearly 200 senior hospital decision-makers rated Boston Scientific the number one medical device company for reimbursement support. The survey, conducted by L.E.K. Consulting, included interviews with CEOs, COOs, CFOs, material managers and purchasing directors at major U.S. hospitals. The survey was part of L.E.K. s annual Strategic Hospital Priorities Study, which offers insights into how medical technology purchasing decisions are evolving in the face of healthcare reform and other changes in the healthcare landscape. The new Extractor TM Pro Retrieval Balloon is now available in both short (RX) and long wire versions. An enhancement of Boston Scientific s market-leading Extractor products, all Extractor Pro balloons feature improved reliability from thicker latex, two distinct inflation sizes on every balloon, and squared shoulders designed to create a flat surface for stone extraction. Long wire versions add improved catheter stiffness to improve pushability down the channel of the duodenoscope. New Laser Probes for SpyGlass System Boston Scientific has entered into an agreement with Lumenis, Ltd. for a laser compatible with the SpyGlass Direct Visualization System. Once stones are visualized, the Lumenis VersaPulse TM Holmium Laser and the Lumenis SlimLine TM GI Fiber 365 micron Laser Probe can be used with the SpyScope Access and Delivery Catheter to treat large stones in the biliary and hepatic ducts. Boston Scientific also has an agreement with Northgate Technologies for an EHL fiber offering physicians a full range of large stone treatment solutions. The survey also asked the hospital executives to rate the importance of product selection criteria across 11 dimensions of expectations from medical device companies. Product quality and reimbursement ranked the most important purchasing criteria, further highlighting the significance of BSC s Best-in-Class designation in the reimbursement category. Boston Scientific Recognized by J.D. Power and Associates Boston Scientific has been recognized for call center operation customer satisfaction excellence for a sixth consecutive year under the J.D. Power and Associates Call Center Certification Program. The distinction acknowledges a strong commitment by Boston Scientific s call center operations in Quincy, MA to provide An Outstanding Customer Service Experience. To become certified, the Company s call center successfully passed a detailed audit of more than 100 criteria that encompassed its customer satisfaction measurement and analysis strategies, recruiting, training, employee incentives, quality assurance capabilities and management roles and responsibilities. J.D. Power and Associates also randomly surveyed Boston Scientific customers who had recently contacted the call center. The evaluation criteria include customer service representative courtesy, knowledge and customer concern, promptness in answering a call and timely resolution of a problem or request. Warning: The safety and effectiveness of biliary metal stents for use in the vascular system has not been established. The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. ACCESS Magazine was produced in cooperation with several physicians. The procedures discussed in this document are those of the physicians and do not necessarily reflect the opinion, policies or recommendations of Boston Scientific Corporation or any of its employees by Boston Scientific Corporation or its affiliates. All rights reserved. SME17540 April 2011 DINEND2275EA

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