Preliminary report on a EUS guided pseudocyst drainage with a new lumen apposing metal stent (SPAXUS™); single center, 9 months experience   Background and AimsEndoscopic ultrasound (EUS)-guided drainage has become a mainstay for treating peripancreatic fluid collection and fully covered metal stent provided more efficient drainage than plastic stent. Recently, wide-flanged fully covered metal stent is introduced in EUS-guided pseudocyst drainage and showed promising results. The aim of this study was to evaluate the feasibility and efficacy of EUS-guided pseudocyst drainage with a new lumen apposing metal stent (Niti-S™ SPAXUS™ Stent; Taewoong Medical, Seoul, Korea).MethodA prospective, single-arm, multicenter feasibility study of EUS-guide pseudocyst drainage with SPAXUS™ is now enrolling patients at 6 tertiary hospital in Korea. This preliminary report describes single center, 9 months experiences of the multicenter study. Between January and September 2016, a total of 11 patients were treated with EUS-guided pseudocyst drainage with SPAXUS™ in our institute. Baseline characteristics and outcomes including technical/clinical success rate, adverse event, and recurrence rate were evaluated.ResultThe median age of 11 patients was 57 (42-76) and male was 10 of 11 patients. The median size of PFC was 80 mm (60-160 mm). SPAXUS™ was successfully placed all patients and PFC resolution was achieved in all 11 patients at median of 35 days after stent placement. The median procedure time was 7 min (5-10 min). Three cases of fever were developed during immediate post-procedure period and all of them were successfully treated with intravenous antibiotics. No other immediate post-procedure adverse events were seen. One case of stent occlusion was developed 40 days after procedure and endoscopic stent cleaning with retrieval balloon was conducted. Until now, no case of PFC recurrence was observed.ConclusionEUS-guided pseudocyst drainage with SPAXUS™ was conducted effectively and safely in our institute until now. Further multicenter experience would be helpful to clarify the role of this procedure.-----  

IDEN 2016 (International Digestive Endoscopy Network) Seoul, Korea  International Digestive Endoscopy Network (IDEN) 2016 was held in Seoul, Korea from June 24 to June 26, 2016. At IDEN congress, many physicians and researchers from all over the world would participated to present and discuss the latest advances in the field of upper GI, lower GI and pancreatobiliary endoscopy. During IDEN congress period, we invited key opinion leaders and our partners to the Taewoong Medical factory to introduce our production process. Stent production tour was arranged to look all around the each production rooms, in addition we had Endoscopic RFA hands-on experience.“It was first time to see how to make hand-made metal stent and impressive the many steps for producing the one stent.” said one of participants.We also prepared Korean traditional dinner and had a great time with all of them.We have invited KOLs and partners to Korea twice an annual event on June and October during IDEN and SGI domestic congresses. Upcoming next official factory tour will be held on October 6 before the day of SGI congress. To learn more about SGI and factory tour, please contact your territory manager.   

DDW 2016 (Digestive Disease Week), San Diego, USA  Taewoong Medical participated DDW 2016 with a huge attention of attendees in San Diego, USA. Exhibition booth consisted of SPAXUS™ Stent section, Endoscopic RFA area, Stent area and extended meeting rooms. Design concept was simple and modern, which emphasized full exposure of our company identity. Especially we prepared to demonstrate SPAXUS™ user friendly delivery system so that visitors could try easy deployment.   The day before DDW, Taewoong Medical organized partner’s day with global distributor at Holiday Inn, Bayside. We had SPAXUS Hands on class with special dummy model and a lively discussion time about EUSRA & ELRA, Endoscopic RFA products. In particular, Euromedical, Italy presented their sales strategy and current state of RFA business, and this invaluable sharing would stand partners in good stead when it comes to meeting customers. Mr. Shin, CEO, Taewoong Medical, expressed thanks to the all partners regarding their effort and cooperation in closing remark.   2nd day of DDW congress, the valued customers and friends from all of the world were invited to SeaWorld, attraction of San Diego. Taewoong Medical prepared special show with killer whales and dinner buffet beside the pool. All attendees seem to return to the innocence of childhood during the show, and they had a great time even though some of them were dripping wet by whales.Upcoming next DDW 2017 is going to be held at Chicago. Hope we can get together again!  

Website Renewal to become more easily to access even if you can access mobile device Have you visited our website lately?You can see optimize pages whichever way you look at it.  PC Screen Shot We have finished website renewal to become more easily to access and use even if you can access mobile device and also renewed the entire design and the structure of previous website in order to make easier to use and more convenience for obtaining necessary information with regard to our business activities and products for valuable customers and business partners through brand new website. We aim to proactively and effectively deliver updated valuable information regarding our business activities, products and services to customers and we also utilize our website as a part of sales and marketing tools for global users. As you know we have also opened Facebook webpage and we always aim to have a better communication with partners and customers! Please visit the updated TaeWoong Website and send us the sincere feedback! Mobile Screen Shot   Through recent update, following new pages and products been added into the website.Customer Service: You can find General product information which is frequently asked like MRI Information, Storage.Meet Us At: Find congress and TW event informationProduct:M Biliary StentEndoscopic Accessory OPTIMOS™

Natsuyo Yamamoto, MD, PhD, from The University of Tokyo writes about her article“Preliminary report on a new, fully covered, metal stent designed for the treatment of pancreatic fluid collections.”   Although efficacy of endoscopic cystogastrostomy for pancreatic fluid collections is reported, few stents dedicated for this purpose are commercially available. We evaluated a newly developed, short metal stent with wide lumen diameter customized for cystogastrostomy in 9 cases. Technical success rate was 100% without early adverse events. Direct endoscopic necrosectomy through the stent was successful in all 3 attempted cases. Stent removal was achieved without difficulties in all 6 cases.   THE NEW FULLY COVERED METAL STENT (NAGI STENT, TAEWOONG-MEDICAL CO, LTD, YEONGGI-DO, KOREA) The placement of this metal stent in the treatment of pancreatic fluid collection may prevent complications such as migration and peritonitis. A wide stent lumen enables direct endoscopic necrosectomy through the stent.A plastic stent has been commonly used for enterocystostomy. Endoscopic treatment for pancreatic fluid collection including necrosectomy is technically feasible using this new metal stent. The safety, efficacy, and indication should be evaluated in larger prospective studies.Read the abstract for this article here.The information presented in Endoscopedia reflects the opinions of the authors and does not represent the position of the American Society for Gastrointestinal Endoscopy (ASGE). ASGE expressly disclaims any warranties or guarantees, expressed or implied, and is not liable for damages of any kind in connection with the material, information, or procedures set forth.

 한덕현 교수, 유럽서 요관스텐트 라이브수술 시연덴마크 코펜하겐 학회에서 유벤타 스텐트 주제로 시연 및 강의기사입력시간 : 2013-09-26 11:08:39최종편집시간 : 2013-09-26 11:08:39이혜선 기자    [청년의사 신문 이혜선]성균관의대 삼성서울병원 비뇨기과 한덕현 교수가 지난 3~7일 5일간 덴마크 코펜하겐에서 열린 EAU(유럽비뇨기과학회) 주관, 요로결석학회 및 수술 워크숍(2nd Meeting of the EAU Section of Urolithiasis(EULIS))에서 유벤타 스텐트(Uventa stent)라는 주제로 라이브수술 및 강의를 시행했다.3일 열린 수술 워크숍(surgical workshop)에서는 네 종류의 요관용 금속스텐트에 대한 강의 및 라이브 수술이 시연됐다.한덕현 교수는 라이브 수술자로 참석하여 새로 개발된 이중금속커버스텐트에 대한 논문(Efficacy and safety of a novel, double-layered, coated, self-expandable metallic mesh stent (Uventa™) in malignant ureteral obstructions) 및 임상경험을 소개했으며 악성종양으로 인한 요관폐색 환자에게 성공적으로 수술을 시연해 참가 의료진들로부터 주목을 받았다.한덕현 교수는 “요관협착은 타장기에 비해 금속스텐트의 적용이 늦게 시작된 분야로서, 기구의 발전과 임상경험의 축적이 절실한 상태”라며 “삼성서울병원에서는 이미 보편화된 수술 경험이, 이제 시작하는 유럽의 의사들에게는 많은 관심을 유발한 것 같다”고 소감을 밝혔다.EULIS는 유럽비뇨기과학회(EAU)에서 결석 및 비뇨내시경 관련 학술모임을 활성화하고자 만든 세부학회로 올해로 2회째를 맞고 있다. 금번 학회는 유럽의 요로결석 전문가 300여 명이 참석한 가운데 개최됐다.http://www.docdocdoc.co.kr/news/newsview.php?newscd=2013092600007

  Leading off the 2nd EULIS Meeting in Copenhagen was a special pre-conference symposium on metal stenting of the ureter on September 4th. This special event took place in the Copenhagen University Hospital, the Rigshospitalet, and featured live surgery demonstrations. Mr. Noor Buchholz was key in bringing together all four companies producing metal stents for the first time. “About two years ago, I had a vision for bringing together the four companies involved in the development and production of metal stents. As the EULIS Section meeting was approaching, we decided to piggy-back the stent workshop as a pre-meeting symposium,” Buchholz explained.“Metal stents are very much a niche market, so I think it’s more important for the companies to work together to spread awareness of these products, rather than compete for a small target audience. I’m trying to raise awareness of the use of metal stents in urology, because I think they are very useful for the “right” patients.”Mr. Buchholz points out two major problems of preconceptions about metal stenting. “We’ve seen metal stents in the past that simply didn’t work, so older urologists won’t touch them. The second problem is related: younger urologists aren’t being taught about them, and might not even be familiar with them.”According to Buchholz, this newer generation of stents, as developed in the past ten years has one key advantage over the older models: they are much easier to place and remove, which can be done through minimally invasive surgery. The biggest advantage compared to contemporary competitors like the double-J stent is their longevity:“The initial purchase price is considerably higher, but because the stents do not have to be replaced two or three times per year like plastic stents, the patient requires less surgery, making it cost-neutral in the first year. From the second year onward, it’s an annual saving of some €5000 per patient. And the patient won’t have to undergo regular surgery, with all of the disadvantages thereof. It’s a great solution for patients who need long-term stenting. One of my patients has had a stent for 80 months now.”The four companies involved in the symposium were PNN Medical with its Memokath thermolabile nitinol stent, Cook Medical with its grooved metal double-J Resonance stent, Allium with its self-expanding polyurethane stent, and Taewoong with its Uventa Ureteral Stent, another self-expanding stent. The live surgery demonstrations were given for each of the four companies’ stents.Other presentations at the symposium showed the current state of developments, techniques for placement and maintenance, as well as a look into the future of metal stents. Biocompatibility and biodegradability are two important properties for improved treatment of patients. Other innovations are the antibody-coated stents, nanotube coating and radioactive stents for internal treatment. An absorbable magnesium metal stent is to combine the inertness of biomaterial with the stability of a metal.

Metal stents for lumen apposition for EUS-guided drainageJong Ho Moon, MD from the Digestive Disease Center and Research Institute at SoonChunHyang University School of Medicine in Bucheon/Seoul, South Korea discusses this New Methods article “A newly designed fully covered metal stent for lumen apposition in EUS-guided drainage and access: a feasibility study (with videos)” from the June issue.   EUS-guided transenteric drainage by using a newly developed fully covered metal stent that is capable of lumen apposition was successfully performed in animal study and small sized clinical experiences. This stent is equipped in conventional delivery system, and preventive for migration and leak because of backwardly folded flanges in both ends and full covering of stent.As EUS-guided therapeutic interventions have evolved, development of metal stents for safe and effective procedures is needed.The EUS-guided drainage was successfully performed by using the new stent. There were no adverse events such as migration or leakage. Endoscopic interventions through the stent was immediately possible, and the stents were easily removed after 4 weeks in patients with pancreatic pseudocyst. Large scaled clinical studies are warranted.Additional expected usage of this new stent is choledochoduodenostomy or temporary insertion into the gallbladder for formation of an access route to perform endoscopic interventions.Read the article abstract here.   Figure 1. A, A new fully covered metal stent having folding-back wide anchoring flanges for lumen apposition. B, A 10F conventional delivery system with a constrained stent  The information presented in Endoscopedia reflects the opinions of the authors and does not represent the position of the American Society for Gastrointestinal Endoscopy (ASGE). ASGE expressly disclaims any warranties or guarantees, expressed or implied, and is not liable for damages of any kind in connection with the material, information, or procedures set forth.

Ryosuke Tonozuka, MD, from the Depatment of Gastroenterology and Hepatology at Tokyo Medical University in Tokyo, Japan discusses this New Methods article“EUS-guided drainage of hepatic abscess and infected biloma using short and long metal stents (with videos).” Refractory hepatic abscess (HA) and infected biloma (IBL), in which inflammation does not improve only by the dosage of the antibiotic agent, often require percutaneous drainage (PCD) and surgical interventions. Recently, the usefulness of EUS-guided hepatic abscess drainage (EUS-HAD) and US-guided biloma drainage (EUS-BLD) has been described. However, there has been only 1 report of a case in which a fully covered self-expandable metal stent (FCSEMS) was used. In this study, we evaluated the safety and efficacy of EUS-HAD and EUS-BLD using a FCSEMS retrospectively.We used 2 types of FCSEMSs for the drainage. If the target lesion was close to the digestive tract (≤2 cm), a short biflanged FCSEMS (short stent; 16 mm in diameter, 2 or 3 cm in length) was used. If the target lesion was far (≥3 cm), a conventional biliary FCSEMS (long stent; 8 or 10 mm in diameter, 6 or 8 cm in length) was used. Figure 1. Schema of EUS-guided drainage of HA using a short and large diameter biflanged self-expandable metal stent (short SEMS) The technical success rate was 100% and the clinical success rates of EUS-HAD and EUS-BLD at the first session were 71.4% and 83.3%, respectively. In 2 cases, they needed necrosectomy (endoscopic necrotic tissue removal) as an additional therapy. The final clinical success rate was 100%. There were no procedure-related adverse events and no cases of recurrence during the follow-up period (median, 83.5 days).We think EUS-guided drainage has several advantages over PCD as follows: 1) one-step internal drainage is suitable for patients not only for cosmetic reasons but also for physiologic liquid flow; 2) there is no risk of self-removal of the external drain, which causes peritonitis; 3) possible drainage of the lesion around the caudate lobe where puncture may be difficult. Furthermore, a 10-mm-diameter fully covered or 16-mm-diameter fully covered self-expandable metal stent (SEMS) may have several advantages compared with 1 or more conventional PS for treatment by EUS-HAD and EUSBLD as follows: 1) only 1 stent is required because of the large diameter; thus, FCSEMS placement may allow fewer sessions and reduce the procedure time; 2) minimum leakage of liquid in the cavity; 3) upon FCSEMS placement, sufficient drainage is expected, leading to rapid improvement; 4) DEN can be easily performed through the large-bore stent, as was seen in this study, as DEN was easily performed through the FCSEMS in 2 cases; and 5) FCSEMSs may be helpful for hemostasis when unexpected bleeding from the tract occurs during the procedure.   Figure 2. Schema of EUS-guided drainage of biloma using a usual long biliary self-expandable metal stent (long SEMS)  The information presented in Endoscopedia reflects the opinions of the authors and does not represent the position of the American Society for Gastrointestinal Endoscopy (ASGE). ASGE expressly disclaims any warranties or guarantees, expressed or implied, and is not liable for damages of any kind in connection with the material, information, or procedures set forth.

Shuntaro Mukai from the Department of Gastroenterology and Hepatology at Tokyo Medical University in Tokyo, Japan describes this VideoGIE case “Pulsating pseudoaneurysm in a walled-off necrosis.”   Our video case describes a pulsating pseudoaneurysm in the cavity of a walled-off necrosis (WON) diagnosed by endoscopy through a fully-covered biflanged metal stent (BFMS). Subsequently, the pseudoaneurysm was successfully treated. A 38-year-old man developed an infected WON after severe necrotizing pancreatitis. A novel BFMS (16 mm in diameter and 20 mm in length) was placed under EUS guidance. Then, direct endoscopic necrosectomy (DEN) was performed through the BFMS. Seven days after DEN, he vomited blood; we suspected bleeding from the cavity. Emergency angiography was not able to detect any obvious bleeding point. After seven days of conservative therapy, an endoscope was advanced to examine the condition within the cavity. Surprisingly, a pulsating pseudoaneurysm was found. Subsequently, the pseudoaneurysm was treated by coil embolization. Interestingly, a “second-look” endoscopy determined that the pseudoaneurysm completely resolved after use of the embolization coil.To the best of our knowledge, this is the first video which shows a pulsating pseudoaneurysm detected by direct endoscopic imaging and subsequently successfully treated by coil embolization. Bleeding from the cavity due to the rupture of a pseudoaneurysm is a fatal complication in patients with WON. Thus, the management of bleeding is mandatory for treatment success.BFMS is useful for the treatment of WON also in that observation in the cavity of WON by endoscopy can be easily performed during the treatment course.Find more VideoGIEs available online. Figure 1. Endoscopic imaging revealed a pulsating pseudoaneurysm (A). A “second-look” endoscopy demonstrated that the pseudoaneurysm completely resolved after use of the embolization coil (B). Angiography revealed a pseudoaneurysm (C), which was subsequently treated by coil embolization (D).  The information presented in Endoscopedia reflects the opinions of the authors and does not represent the position of the American Society for Gastrointestinal Endoscopy (ASGE). ASGE expressly disclaims any warranties or guarantees, expressed or implied, and is not liable for damages of any kind in connection with the material, information, or procedures set forth.

Prashant Kedia, MD from the Division of Gastroenterology and Hepatology, Weill Cornell Medical College at Cornell University in New York, New York, USA shares this video case “Hemorrhagic pancreatic necrosis drainage by using an esophageal stent.”   This video highlights the case of a patient with infected hemorrhagic pancreatic necrosis treated with endoscopic debridement through a fully covered metal esophageal stent. Initially, double pigtail plastic stents were placed due to the fluid nature of the contents. However due to an acute bleeding event into the collection possibly secondary to a pseudoaneurysm, the patient developed hemorrhagic pancreatic necrosis which subsequently became infected. To endoscopically manage this situation, direct necrosectomy was required via EUS-guided placement of a fully covered metal esophageal stent with through-the-scope deployment into the walled-off hemorrhagic pancreatic necrosis. Through this multiple techniques for debridement including usage of snares and nasocystic drains were applied to evacuate the cavity.   This video is useful to portray the advantage of using fully covered metal stents for walled off pancreatic necrosis compared to plastic stents. Due to large lumenal diameter of these metal stents, they allow for direct endoscopic necrosectomy and removal of large solid material. Although only one metal stent is currently approved for pseudocyst drainage in the United States, fully covered, through-the-scope esophageal stents can also be used in these situations.The application of EUS-guided cystgastrostomies with fully covered metal esophageal stents have been shown in prospective case series to allow for successful endoscopic necrosectomy of walled off pancreatic necrosis. These stents allow for maintenance of a gastrocystic fistula through which multiple necrosectomy sessions can be performed and a nasocystic drain can be placed for continuous flushing.Find more VideoGIEs available online.The information presented in Endoscopedia reflects the opinions of the authors and does not represent the position of the American Society for Gastrointestinal Endoscopy (ASGE). ASGE expressly disclaims any warranties or guarantees, expressed or implied, and is not liable for damages of any kind in connection with the material, information, or procedures set forth.