Becker's ASC Review

32 GI & ENDOSCOPY SECTION: GI Company Corner 20 GI/Endoscopy Company Updates for the 1st Half of 2015 By Carrie Pallardy Here are 20 news updates on gastroenterology and endoscopy company ac- tivity in the first half of this year. 1. Boston Scientific received FDA 510(k) clearance for its SpyGlass DS Di- rect Visualization System. e system is cleared for use in the diagnosis and treatment of pancreatico-biliary disease. 2. Boston Scientific signed a definitive agreement to acquire Xlumena, a device company that focuses on the development, manufacture and sale of minimally invasive devices for endoscopic ultrasound. Boston Scientific will pay $62.5 million upfront and an additional $12.5 million when the HOT AXIOS system receives FDA clearance. 3. EndoChoice named Scott Huennekens its chairman of the board. 4. EndoChoice closed its initial public offering and raised $94.9 million. 5. EndoChoice completed the refinancing of its outstanding debt. e com- pany closed on a $58 million senior secured credit facility with Midcap Fi- nancial and Silicon Valley Bank. 6. Exact Sciences and Mayo Clinic, based in Rochester, Minn., announced a five-year extension and expansion of their collaboration. e new agreement focuses on Exact Sciences' relationship with Mayo Clinic gastroenterologist and co-inventor of Cologuard David Ahlquist, MD. 7. e Wisconsin Economic Development offered Madison, Wis.-based Ex- act Sciences $9 million in tax credits if the company creates at least 750 jobs and capital investment of $26 million by 2020. 8. Skiff Medical Center in Newton, Iowa, purchased new technology to update its endoscopy suite. e medical center purchased FUJIFILM technology. 9. Medigus was listed and began trading American depository receipts on the NASDAQ Capital Market under the ticker symbol MDGS. 10. Norgine and Arc Medical Design partnered to distribute the ENDO- CUFF VISION device. e ENDOCUFF VISION is a single-use, sterile en- doscopic overtube designed to improve extubation and visualization during colonoscopy. 11. Seven patients were infected with carbapenem-resistant Enterobacteria- ceae aer undergoing ERCP at UCLA Ronald Reagan Medical Center in Los Angeles. Olympus, the manufacturer of the scopes used in these cases, now faces lawsuits from five of these patients. 12. In letters dated March 26, Olympus sent updated, validated manual reprocessing instructions for its TJF-Q180V duodenoscopes. e FDA re- viewed the new reprocessing instructions and validation data as part of the ongoing review of the scopes' 510(k) process. 13. Olympus launched a new guarantee program for its surgical business that will provide next-day replacements for surgical equipment at no additional charge. 14. PENTAX Medical named David Woods, previously the company's president of the Americas, its new chief marketing officer, effective April 1. Christopher Burton will succeed Mr. Woods as the company's president of the Americas. 15. Hoya Group PENTAX Medical launched its Splash M-Knife, designed for endoscopic submucosal dissection. 16. Physicians Endoscopy and four gastroenterologist partners officially opened the Greater Gaston Endoscopy Center in Gastonia, N.C. 17. Physicians Endoscopy acquired a majority interest in the Philadelphia Gastroenterology Consultants Endoscopy Center of Excellence. 18. Physicians Endoscopy acquired the Endoscopy Center of West Central Ohio in Lima. On April 1, Physicians Endoscopy and Gastro-Intestinal As- sociates finalized the joint venture. 19. Physicians Endoscopy acquired a minority interest in Garden State En- doscopy Center in Kenilworth, N.J. e company now has 40 centers. 20. US Endoscopy released its Histolock Resection Device. e device has a stiff monofilament wire. It is designed to resect flat lesions during difficult polypectomy procedures, such as endoscopic mucosal resection. n 7 Things to Know About Endoscopy Competency Training By Carrie Pallardy A recent study published in e American Journal of Gastroenter- ology examined gastroenterology fellowship programs' readi- ness for competency-based evaluation in endoscopic proce- dural training. Here are seven things to know about the study. 1. e study authors surveyed GI program directors and trainees ac- credited by the Accreditation Council for Graduate Medical Education. e survey was designed to evaluate domains relevant to endoscopy training and competency assessment. 2. Of the program directors that responded to the survey, 23 percent reported they did not have a formal endoscopy curriculum. 3. Program directors placed less importance on endoscopy volume, ad- enoma detection rate and withdrawal rates in determining competency compared with trainees. 4. e majority of program directors (85 percent) reported that compe- tency is assessed by procedure volume. Ninety-six percent of program directors reported teaching attending valuations as the primary tool for assessing competency. 5. e minority of program directors (30 percent) reported using skills assessment tools. Just 28 percent of program directors reported using specific quality measures. 6. Program directors rated their overall quality of endoscopy training and competency assessment as better than overall ratings from trainees. 7. e research authors concluded most training programs rely on procedure volume and subjective attending evaluations to determine overall competency. e authors suggest there is a need for improved endoscopy curriculum. n

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