Women s Health. Product innovation. Commitment. We are committed to you... and advancing the quality of your patient care.

Transcription

1 II Commitment We are committed to you... and advancing the quality of your patient care.

2 Boston Scientific is always there for you, your physicians and your patients. We are anchored in our guiding principle to provide innovative Obtryx II products that are supported with clinical data and offer robust professional programmes to advance the quality of care. Boston Scientific is committed to developing new products, improving existing product lines and exploring new, innovative ways to treat pelvic floor diseases and related areas. Boston Scientific is committed to supporting evidence-based medicine through sponsoring and funding women s health research worldwide for the treatment of female stress urinary incontinence and pelvic organ prolapse. Boston Scientific is committed to helping you and your patients advance knowledge around these disease states and treatment options.

3 The & Advantage Transvaginal Mid-Urethral Sling Systems are retropubic offerings designed to create a new standard for Obtryx II Designed for greater ergonomics, needle stability, and control during delivery. sling placement. The Advantage Fit Transvaginal Mid-Urethral Sling System was designed with a 46% thinner needle and 17% tighter curve than the Advantage System to reduce insertion force and leave the mesh closer to the pubic bone, reducing potential chance of bowel or bladder injury. & Advantage System Description M Advantage Fit System (single unit) M Advantage Fit System M Advantage System (single unit) M Advantage System System includes: One (1) Delivery Device and One (1) Mesh Assembly Clinical Reference* The Advantage Mesh is a biocompatible knitted polypropylene material which has been heat treated and de-tanged in the sub-urethral portion of the sling. This heat sealed edge is designed to potentially reduce irritation to the anterior urethral wall. It is designed to reduce the risk of mesh deformation and maintain its integrity during tensioning. All Boston Scientific Mid-Urethral Sling Systems feature Advantage Mesh. The Advantage Mesh has been used in over 500,000 patients. In a retrospective review of 72 patients treated with the Advantage System at a mean follow-up of 16 months, 96% (69/72) objective cure rate was observed. Furthermore upon stratification, patients that had low urethral closure pressures (<20 of H20), and/or hypermobility still had an objective cure rate of 87% (13/15)1.

4 The Suprapubic Mid-Urethral Sling System is designed to Obtryx II maneuver through challenging tissue with a smoother association mechanism in the suprapubic pathway. Lynx System Description M Lynx System (single unit) M Lynx System System includes: Two (2) Delivery Devices and One (1) Mesh Assembly Clinical Reference* In a prospective study of 102 patients that were followed up at 1 year, 90% (92/102) were consiered cured by subjective report and a negative standing stress test. There were 4 (3.4%) intra-op bladder perforations and 5 (4.2%) cases of erosion2. Suprapubic Mid-Urethral Sling System

5 The II Mid-Urethral Sling System is a transobturator sling with enhanced features designed for smooth sling placement, intra-operative adjustability with minimal tissue disruption, and increased visualization for physicians to aid in precise sling placement. II Obtryx II System Halo or Curved Description M Obtryx II System - Curved (single unit) M Obtryx II System - Curved M Obtryx II System - Halo (single unit) M Obtryx II System - Halo System includes: Two (2) Delivery Devices and One (1) Mesh Assembly Clinical Reference* In a prospective, randomized control trial, patients were treated with System and Advantage System. The objective cure rate for the Obtryx System was 81% (68/84) and for the Advantage System 77% (67/87). Cure defined as less than 1 gram urine leak in standardized pad test. The subjective cure rate was 98.8% (85/86) for System and 92.6% (88/95) for Advantage System. Pain at the time of the vaginal examine in the transobturator group was 15.5% in the transvaginal group was 5.6%3. Xenform Obtryx II Featuring PrecisionBlue Design

6 Suburethral Transobturator Sling System II The Mid-Urethral Sling System is a transobturator design offering two needle configurations that allow physicians to choose the delivery method that meets their needs. This is for physician preference. The method of delivery is the same. Obtryx System Halo or Curved Description M Obtryx System - Curved (single unit) M Obtryx System - Curved M Obtryx System - Halo (single unit) M Obtryx System - Halo System includes: Two (2) Delivery Devices and One (1) Mesh Assembly

7 The Single Incision Sling System is designed to reduce dissection and associated risk, and to offer a procedure with fewer steps. The mesh carrier tip snap-fits to the delivery device allowing for advanced control and micro-adjustability during placement. Solyx SIS System Description M Solyx SIS System (single unit) M Solyx SIS System System includes: One (1) Delivery Device and One (1) Mesh Assembly Obtryx II Clinical Reference* Single Incision Sling Advanced Control with Micro-Adjustability Long-term, multi-site retrospective results of 69 patients with mean follow up at 43 months showed that 93% of patients were dry and satisfied with their outcome on the basis of subjective assessment. Furthermore, there were no serious adverse events including no bladder, bowel, vessel or nerve perforations and no erosions or extrusions. No pain was reported that was attributed to the implant. There were 4 cases of denovo urge incontinence and 2 reports of transient retention4.

8 The Suture Capturing Device is designed to enable an intra-vaginal, trocar-free, minimally invasive prolapse repair. The Capio Device is designed for use with the System and custom graft repairs. The Capio SLIM Device features a reduced head width and shaft diameter to minimize the space occupied within the surgical field, easy suture loading and a funnel shaped catch, designed for consistent ease of use. 36% Reduction in Head Width Lynx II Capio SLIM Suture Capturing Device Capio OPEN ACCESS Suture Capturing Device Capio Suture Capturing Device Description M Capio Slim Suture Capturing Device Box 1 M Capio Slim Suture Capturing Device M Capio Standard Laparoscopic Box 4 Capio Sutures are available in various lengths with a tapercut needle in both absorbable and non-absorbable suture configurations. Upsylon Over 400,000 Capio Devices have been utilized to date, facilitating vaginal prolapse repairs for over 15 years5. Description M Size Closest Equivalent Non-absorbable, coated braided 0 polyester, double armed with TC tapercut needle (dart) and a T 26mm 1/2 circle taper needle, 36 TI-CRON Sutures / Ethibond Sutures Box 12 M Non-absorbable, coated braided 0 polyester, double armed with TC tapercut needle (dart), 48 TI-CRON Sutures / Ethibond Sutures Box 12 M Non-absorbable, polypropylene monofila- 0 ment, double armed with TC tapercut needle (dart) and a T 26mm 1/2 circle taper needle, 36 Surgilene Sutures / Prolene Sutures Box 12 M Non-absorbable, polypropylene monofila- 0 ment, double armed with TC tapercut needle (dart), 48 Surgilene Sutures / Prolene Sutures Box 12 M Absorbable, coated braided PGA, double 0 armed with TC tapercut needle (dart), 48 Dexon II Mesh / Vicryl Mesh Box 12 M Monodek Absorbable, monofilament PDO, double armed with TC tapercut needle (dart) and a T 26mm 1/2 circle taper needle, 48 PDS Sutures Box 12 0

9 II Matrix Customizable... based on Patient Needs Soft Tissue Repair Matrix is a bovine dermis xenograft. Along with Polyform Synthetic Mesh, these products offer various material choices for a customized pelvic organ prolapse repair. Soft Tissue Repair Matrix Size (cm) M x7 M x7 M x 10 M x 12 Polyform Synthetic Mesh (abdominal approach) Size (cm) M x 15 M x 20 M x 15

10 System The Vaginal Support System with Capio Slim Suture Capturing Device is a minimal mesh intra-vaginal anterior & apical prolapse system designed to avoid mesh overlapping the incision line, and facilitating mesh placement where it is desired.repair. Uphold LITE Vaginal Support System Decription M Vaginal Support System with Capio Slim Suture Capturing Device M Obtryx II Pinnacle Posterior Lite with Capio Slim Suture Capturing Device. System includes: One (1) Device and One (1) Mesh Assembly Clinical Reference* In a retrospective cohort study of the first 115 consecutive patients treated with the Uphold System with a median follow-up of 12.1 months, anterior recurrence was observed in one patient (0.8%) when defined as Ba > 0. Apical recurrence was observed in 2 patients (1.7%) when defined as C>0. The rate for mesh exposure was 3/115 (2.6%). High rates of satisfaction and improved condition-specific QOL were observed6. Pinnacle LITE Pelvic Floor Repair Kit, Posterior It s more than light-weight mesh, it s Low Surface Area and a Reduced Profile delivery device. System in Final Placement with Uterus Present System in Final Placement without Uterus Present

11 II Y-Mesh It s more than light-weight mesh, It s ease of positioning and fixation. The Y-Mesh features lightweight, low surface area technology to minimize mesh contact with the vaginal wall. The mesh handling characteristics, large pores and blue color are designed to ease positioning and fixation to assist with placement. Y-Mesh Decription M Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device The Colpassist Vaginal Positioning Device is the first device specifically designed for vaginal positioning in gynecologic procedures and as a suturing platform for vaginal wall fixation during sacrocolpopexy. Colpassist Vaginal Positioning Device

12 Committed to clinical excellence Boston Scientific is committed to providing clinical data to support our key products. This sample list reflects some of the clinical research we are supporting through our Investigator Sponsored Research programme and internal sponsored trials as we partner with the physician community to achieve clinical excellence. II Capio SLIM PFR Lead Investigator Study Objective Primary Endpoint Target Completion Peter Sand, MD Prospectively assess anatomic/systematic outcomes of Uphold System (Anterior/Apical) for treatment of POP POP-Q Score at 12 months 2014 Peter Sand, MD Retrospectively compare post-operative pain scores for suture-based sacrospinous fixation vs. Uphold System for treatment of POP Post-operative pain scores 2014 Daniel Altman, MD, Christian Falconer, MD Prospectively assess objective and subjective outcomes of Uphold LITE System (Anterior/ Apical) for treatment of POP POP-Q Stage < 1, no bulge 2014 Robert Gutman, MD Prospectively compare anatomic and symptomatic outcomes of Uphold LITE System (Anterior/ Apical) vs. Laparoscopic Sacral Hysteropexy for treatment of POP POP-Q score at 12 months, no bulge symptoms, no retreatment for POP 2015 Renaud de Tayrac, MD2 Prospectively assess anatomic/ symptomatic outcomes of Uphold LITE System (Anterior/ Apical) for treatment of POP POP-Q score at 12 months, no bulge symptoms, no retreatment of POP 2015 Joseph Lee, MD Prospectively compare anatomic/symptomatic outcomes of Uphold LITE System (Anterior/ Apical) vs. Vaginal Hysterectomy for treatment of POP POP-Q scores at 12 months 2016 Prospectively assess objective and subjective outcomes of Uphold LITE System (Anterior/ Apical) for treatment of POP POP leading edge at/beyond hymen, bulge with bother, retreatment for failed POP repair 2018 Prospectively compare objective and subjective outcomes of Uphold LITE System (Anterior/ Apical) to Hysterectomy with Uterosacral Ligament Suspension for treatment of POP POP leading edge at/beyond hymen, bulge with bother, retreatment for failed POP repair Karen Noblett, MD3 PFR Uphold and Vaginal Support Systems Charles Nager, MD4 PFDN/NICHD Soft Tissue Repair Matrix Lead Investigator Study Objective Peter Rosenblatt, MD 5 SUI Lead Investigator Scott Serels, MD Prospectively assess objective and subjective outcomes of Xenform Matrix for treatment of POP Primary Endpoint POP leading edge at/ beyond hymen, bulge with bother, retreatment for failed POP repair Target Completion 2018 and II Transobturator Mid-Urethral Sling Systems SIS System Study Objective Evaluate safety and tolerability of Solyx Single-Incision Sling System Prospectively compare objective and Amanda White, MD subjective outcomes of Solyx SIS System to 6 Joseph Schaffer, MD Obtryx II System for treatment of SUI Primary Endpoint Target Completion Incidence of devicerelated events and patient tolerability 2014 Negative cough stress test and patient improvement (PGI-I) 2017 The following trials have been registered at 1 NCT , 2 NCT , 3 NCT , 4 NCT , 5 NCT , 6 NCT * Results from case studies are not predictive of results in other cases. Results in other cases may vary.

13 The Pelvic Floor Institute (PFI) is an educational resource that contributes to physician knowledge and outcomes. By sponsoring live surgery training opportunities via preceptorships and proctorships, as well as providing hands-on training opportunities at cadaver labs, we aim to enhance pelvic floor surgery techniques and knowledge for the treat ment of pelvic organ prolapse and stress urinary incontinence. II The Pelvic Floor Institute website is a dynamic, virtual educational forum designed to enhance pelvic floor knowledge and product techniques. PFI is comprised of virtual rooms which feature an array of educational tools and facilitate physician connectivity. The updated PFI website is accessible through your PC, tablet or your mobile device. Visit com to access these resources, including procedural webcasts, product videos and animations, patient education materials, the interactive POP-Q System Programme and reimbursement guidelines. Our goal: Design Innovative Solutions The Interactive Pelvic Organ Prolapse Quantification (POP-Q) System Programme is designed to increase your efficiency and enhance your effectiveness during patient consults. The programme minimizes the need to sketch images by hand and it complements your knowledge with interactive disease state animations. It is available on the PFI website as well as an app via itunes.

14 To learn more, visit 1 Julia J, et al. Long-Term Experience in 72 Patients Treated with the Advantage Sling System. Boston Scientific paper Midurethral Sling System: a 1-year prospective study on efficacy and safety. Int Urogynecol J. 2008; 19: Ross S, Magali R, et al. Transobturator Tape Compared with Tension-Free Vaginal Tape for Stress Incontinence, A Randomized Controlled Trial, Obstetrics & Gynecology, 114 (6), Dec 2009, II 4 Serels S, et al. Long Term Follow up of the Single Incision Sling in the Treatment of Female Stress Urinary Incontinence (SUI), Open Journal of Urology, 2014, 4, Capio Suture Capturing Device initially commercialized in Data on file. 6 Vu M, et al. Minimal mesh repair for apical and anterior prolapse: initial anatomical and subjective outcomes. Int Urogynecol J. Published online 25 April *Refer to the article/reference for a complete review of all results All cited trademarks are the property of their respective owners. Please refer to the Product Catalogue for ordering information or contact your local Boston Scientific Representative. CAUTION: 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 labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Data on file. Bench test results may not necessarily be indicative of clinical performance. Results from case studies are not predictive of results in other cases. Results in other cases may vary. URO AA March Boston Scientific Corporation or its affiliates. All rights reserved. DINURO2192EA