and manual purge operations. • Cleansing mode selector allows for toggling between three cleansing modes: low, medium. (default) and high. • Bridge divider ...
A Novel Approach to Intraprocedural Cleansing Minimizing Dependency on Pre-procedural Prep Regimens The Pure-Vu® System is designed to improve the quality and efficiency of the colonoscopy procedure. THE PROBLEM The reported rate of poor bowel preparation ranges from 5-60%, with most studies citing 25%1-6 of patients arrive to their colonoscopies with inadequate visibility of the colon mucosa. These sub-optimally prepared colons often result in: · Reduced ability to detect lesions and disease · Cancelled, delayed, or incomplete procedures · Prolonged critical patient therapy and treatment · Longer and more difficult procedures · Higher complication rates · Increased patient discomfort and use of sedatives and analgesics · For outpatients, reduced time intervals between surveillance procedures ·For inpatients, increased hospital costs due to significant prolonged length of stay and reduced bed turnover rates THE PURE-VU® SYSTEM SOLUTION The Pure-Vu® System is designed to cleanse the colon intraprocedurally to improve visualization in an inadequately prepared colon. The system facilitates the rapid cleansing of the mucosa using a pulsed vortex of water and air to loosen debris from the colon mucosa, while simultaneously suctioning the bowel contents. By effectively and efficiently cleansing the colon intraprocedurally, the Pure-Vu® System puts control back in the hands of the physician and provides opportunity to: · Optimize visibility of colon mucosa for anomaly and disease detection · Expedite diagnosis and treatment · Reduce sole dependency on pre-procedural prep regimens and patient compliance · Reduce incidence of delayed, aborted and incomplete colonoscopies · Enhance patient experience and satisfaction7 The Pure-Vu® System System components include a workstation, foot pedal, loading fixture and custom cart, as well as disposable, single-use slim and standard oversleeves that easily fit over the colonoscope insertion tube. PURE-VU® WORKSTATION ·Pulsed vortex irrigation provides a mixture of water and air to effectively break up fecal matter and clear the field of view ·Proprietary sensing technology detects and mitigates potential clogging · Auto-purge senses and prevents mucosal wall suction ·Low, medium and high cleanse settings provide additional pressure control and are easily activated via the foot pedal ·Intuitive system set-up via color-coded tubing and corresponding pump heads MOTUSGI® ENDOSCOPY CART · Dedicated cart for easy transportability ·Integrated hook and cord wraps support cable/cord management · Utility basket provides convenient storage for supplies ·Integrated IV pole with one-handed height adjustment conveniently consolidates hanging irrigation bag and Pure-Vu® System componentry on one device during set-up, procedure and transport PURE-VU® OVERSLEEVE ·Easily fits over standard and slim colonoscopes (11.7mm 13.7mm OD) ·Preserves procedural flow by not interfering with the working channel ·Facilitates smooth advancement with low-friction hydrophilic coating on distal 80cm of the oversleeve ·Four cleansing ports for pulsed irrigation ·Two large suction channels facilitate effective removal of fecal material ·Sensing channel to detect blockage in suction ports ·Disposable, single patient use provides for easy clean-up post-procedure PURE-VU® FOOT PEDAL ·Easily controls the workstation cleanse, suction and manual purge operations ·Cleansing mode selector allows for toggling between three cleansing modes: low, medium (default) and high ·Bridge divider for resting comfort, quick confirmation of left/right pedal, and to avoid dual depression PURE-VU® LOADING FIXTURE ·Secures the colonoscope while loading the oversleeve · Conveniently fits on any flat surface ·Ergonomic handle allows for easy transport · Weighted to ensure surface stability The Pure-Vu® System demonstrates outstanding cleansing performance. In three multi-center and one single-center studies, patients presenting with an inadequately prepped colon (as determined by the Boston Bowel Preparation Scale) became adequately prepped for colonoscopy after cleansing with the Pure-Vu® System. 8.7 Baseline image 8.7 EEfvfiaclaucaytioinnHoofsBpoiwtAaelifzl tCeedlePraanutsiiensnget of the Pure-Vu® System Evaluation of Bowel Cleansing Population Using the Pure-Vu® Efficacy in Hospitalized Patient System - The Reduce Study4 Population Using the Pure-Vu® System - The Reduce Study4 (N=95) 49 (N=95) 49 "Pure-Vu® is a novel tool that can help improve patient care in the face of previous bad bowel preparation. It was especially useful in a patient at high risk for colon cancer due to a history of multiple, large polyps requiring endoscopic mucosal resection (EMR). She required frequent surveillance, but her inability to tolerate consumption of purgatives limited my ability to truly assess her risk." Sri Komanduri, MD Northwestern Memorial Hospital "Pure-Vu® System, along with a miniprep with magnesium citrate and a clear liquid diet, proved to be a great option for a patient who would have otherwise required an inpatient admission for bowel preparation, and for whom a traditional bowel preparation was not feasible." Brian Jacobson, MD Boston University School of Medicine The Pure-Vu® System Specifications Product Code PV-WSC-02-0 PV-LDF-02-0 EN-CRT-02-0 PV-STO-02-1 PV-SLO-02-1 Description Pure-Vu® Workstation Controller with Foot Pedal Pure-Vu® Loading Fixture for PV-WSC-02-0 MOTUSGI® Endoscopy Cart Pure-Vu® Standard Kit includes oversleeve, umbilical section, unloading kit Pure-Vu® Slim Kit includes oversleeve, umbilical section, unloading kit Specifications Dimensions (W x D x H): 2 50mm x 476mm* x 358mm (10in x 19in x 14in) *520mm (20.5in) with pump head Weight: 18kg (40lbs) Electrical: 100-240VAC/50-60Hz Dimensions (W x D x H): 5 84mm x 267mm x 241mm (23in x 10.5in x 9.5in) Weight: 7.5kg (16.5lbs) Height: 1510mm (59.5in) floor to scope, lowest position 1765mm (69.5in) floor to scope, highest position 807mm (32in) floor to cart, tray Depth: 630mm (25in) max depth, open casters to basket Width: 646mm (25.5in) max width, open casters Weight: 18kg (40lbs) Compatible with standard colonoscopes OD: 12.8-13.7mm Length: 1630-1710mm Compatible with slim colonoscopes OD: 11.7-13.3mm Length: 1630-1710mm References 1.Borg B, Gupta N, Zuckerman G, Banerjee B, Gyawali C. Impact of obesity on bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2009;7:670675 2. 2. Rex D, Imperiale T, Latinovich D, Bratcher L. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002;97:16961700 3. 3.Lebwohl B, Kastrinos F, Glick M, Rosenbaum A, Wang T, Neugut A. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011;73:120712144. 4.Tan-Torres Edejer T, Baltussen R, Adam T, Hutubessy R, Acharya A, Evans D., et al. Making Choices in Health: WHO Guide to Cost-Effectiveness Analysis. Geneva, Switzerland: World Health Organization; 2003. 5.Harewood G, Sharma V, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003;58(1):76-79. 6. Krygier D, Ennis R. The inpatient colonoscopy: A worthwhile endeavor. Can J Gastroentero l. 2008;22(12)977-979. 7.van Keulen K, Neumann H, Schattenberg J, van Esch A, Kievit W, Spaander M, Siersema P. A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: A feasibility study. Endoscopy. 2019 Jan;51(1):85-92. www.motusgi.com 1.844.PUREVU1 1.844.787.3881 Pure-Vu is a registered trademark of Motus GI Holdings, Inc. © 2019 Motus GI Holdings, Inc. ML00002 Rev F For more information about the procedure, indications, contraindications, warnings and precautions, please contact MOTUSGI or consult the complete Instructions for Use (IFU) at www.motusgi.com.Adobe InDesign 14.0 (Macintosh) Adobe PDF Library 15.0