Our Commitment to. Thoracic Surgery

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2 Contents Vision and Mission Overview of Lung Disease Early Diagnosis Understanding Your Goals Our Commitment Shaping the Future of Surgery Research and Evidence Elevating the Standard Improving Outcomes Partnerships Education and Training Best-in-Class Education Professional Education Courses Resources Touch Surgery Access and Reimbursement Lung Cancer Screening Support Improving Patient Access Our Tools Innovative Products Knowledge and Insight Product Overview ECHELON FLEX TM POWERED VASCULAR STAPLER ECHELON FLEX TM GST System HARMONIC HD 1000i Shears Portfolio Comparison Summary Click on the above to navigate to page Click on lower right of any page to navigate to directory 2

3 Our Vision Shaping the future of surgery Our Mission Our purpose is to advance innovation in surgery, address the world s most pressing health care issues, and help improve and save more lives FOR INTERNAL USE ONLY

4 Lung disease is a serious condition that demands attention Reasons for thoracic surgery 100,000 thoracic procedures annually 1 Leading reason for thoracic surgery is cancer 2 The significance of thoracic cancer 3 2nd most common cancer in the US Leading cause of cancer death 26% Only 16% of lung cancers are diagnosed at a localized stage Common surgical complications 4 Prolonged air leaks 8% Atrial arrhythmia 9% Pneumonia 3% High health care utilization and costs (including hospital-based costs) In a 2012 published study 5 : >300,000 US hospitalizations cited a diagnosis of lung cancer 7-day mean length of stay (vs 7.12 days for all conditions) $15,600 mean hospital cost per stay (vs $18,267 for all conditions) 1. Truven Health Analytics (Thomson/Solucient), USA Procedure Volumes Thoracic surgery. (2017). Retrieved from 3. American Cancer Society. Cancer Facts & Figures Atlanta: American Cancer Society; Paul, S., Altorki, N. K., Sheng, S., Lee, P. C., Harpole, D. H., Onaitis, M. W.,... Damico, T. A. (2010). Thoracoscopic lobectomy is associated with lower morbidity than open lobectomy: A propensitymatched analysis from the STS database. The Journal of Thoracic and Cardiovascular Surgery, 139(2), Anhang Price, R. (RAND), Stranges, E. (Thomson Reuters) and Elixhauser, A. (Agency for Healthcare Quality and Research). Cancer Hospitalizations for Adults, HCUP Statistical Brief #125. February Agency for Healthcare Research and Quality, Rockville, MD. 4

5 Earlier diagnosis and treatment are critical to improvements in patient outcomes Unfortunately, most lung cancers are not detected in early stages; only 16% of patients have localized disease at diagnosis 3 43% 6 55% 3 25% 7 18% 3 1-year survival rate 2-year survival rate 5-year survival rate 5-year survival rate with early diagnosis and treatment How can we work together towards the goal of prolonging survival and preserving quality of life for more lung cancer patients? 6. Tas, F., Ciftci, R., Kilic, L., & Karabulut, S. (2013). Age is a prognostic factor affecting survival in lung cancer patients. Oncology Letters, 6, Lung Cancer Symptoms, Stages, Treatment & More. (2017). Retrieved from 5

6 Our commitment is to help improve the quality of health care Using our strength and breadth of offerings to advance the treatment of thoracic conditions We are collaborating with the Shanghai Discovery Center, which targets four disease areas: hepatitis, chronic obstructive pulmonary disease (COPD), lung cancer, and hematologic malignancies 8 We are partnering with you to create meaningful solutions that enhance your patients lives and improve outcomes 8. Janssen China R&D. (2015). Retrieved from 6

7 Shaping the future of surgery in the fight against lung cancer and lung disease Our comprehensive approach helps achieve the goal of best outcomes and well-being for patients Research and Evidence Education and Training Access and Reimbursement Innovative Products 7

8 Research and Evidence Our relentless investment in evidence to support patient care 8

9 We invest in research to help advance treatment options and improve outcomes Resulting in clinical and economic insights to drive effectiveness and efficiencies Click on each study to activate hyperlink 9

10 We partner with societies to advance education, research, and patient care Initiatives with key societies The Society of Thoracic Surgeons Society sponsorship support Industry educational events STS live tissue labs American Association for Thoracic Surgery Society sponsorship support Industry educational events and dinners AATS porcine tissue labs Women in Thoracic Surgery Society sponsorship support Industry educational events and dinners 10

11 Education and Training Our commitment provides best-in-class education throughout every step of the process FOR INTERNAL USE ONLY 11

12 We are committed to help health care professionals be better equipped to improve surgical and hospital success World-class education through access to top faculty and use of emerging technologies First-to-market programs designed to immerse customers in the most pressing topics and emerging trends of today Active involvement in advocacy for treatment improvements with key societies 12

13 We provide best-in-class educational programs to further professional development Extensive experience delivering training in thoracic surgery 196 thoracic training events held 2015 through thoracic health care professionals trained Comprehensive professional education Team based and individual Regional and local programs Web based and face to face Customizable learning journey tailored to your educational needs 13

14 Professional education courses Comprehensive approaches to advanced thoracic surgery This course allows the learner to engage in discussions on traditional VATS pulmonary resections, robotic-assisted VATS resections, uniportal VATS resections, and MIEs. Robotic VATS: Refining the skills of the surgical team Interactive OR preceptorship for those interested in refining their robotic-assisted thoracic procedures skills. The program will address patient selection, procedural indications and contraindications, and techniques. It will also include instruction on the safe and effective use of nonrobotic bedside instrumentation. VATS Lobectomy: A practical, hands-on experience This preceptorship with animate laboratory experience is designed for thoracic surgeons and their surgical teams who have experience performing VATS and wish to expand their minimally invasive techniques to include VATS lobectomy. 14

15 Resources to support your patients, surgical teams, and organization Patient Educational brochures and videos Find a Surgeon tool and question guide Thoracic shared decision-making tool Surgical team Website covering disease, treatment options, innovative products, and education programs Touch Surgery modules to help inform professionals about thoracic surgery options Science of Tissue Management presentation specific to thoracic surgery Highly knowledgeable specialty sales representatives Thoracic solutions video to demonstrate Ethicon s commitment to thoracic surgery Hospital administration Reimbursement and coverage information HCP resource website: 15

16 Revolutionizing surgical education through a virtual training mobile platform Allows surgeons to rehearse simulated surgery anytime, anywhere Delivers cognitive training that has the potential to improve outcomes A growing library of more than 100 surgical procedures Touch Surgery features content developed in collaboration with the Johnson & Johnson Institute and top surgeons around the world. Learn and master key surgical steps in: General surgery Bariatric surgery Colorectal surgery Gynecologic surgery Hepatobiliary surgery Orthopaedic surgery Thoracic surgery And many more Click here to learn more 16

17 Access and Reimbursement Helping patients have access to the care they need 17 FOR INTERNAL USE ONLY

18 Ethicon lung cancer screening support Provided by: Radiologists/ Nurse Navigator Information for: Patients Improving Lung Health Post Screening Information Educational brochures Referring patients to lung cancer screening The importance of screening a shared decision making guide Post screening information Establishing and growing your lung cancer screening program Lung cancer screening best practice videos Current state What s new Screening program set-up Risks, challenges, and opportunities How Ethicon can help Information for: Surgeons and Hospitals Lung Cancer Screening Studies, Evidence, Endorsement, and Guidelines Summary Evidence compendium Studies, evidence, endorsement, and guidelines summary 18

19 Our US Health Economics and Market Access (HEMA) Team Our team works with payors, providers and other health care advocates to support value-based clinical and economic decision making to provide access to Ethicon products and procedures. We offer tools and resources to demonstrate the clinical and economic value of thoracic surgery to patients, payors, and clinical and nonclinical stakeholders. US HEMA also offers: Evidence-based tools such as economic models Medical policy and benefit design advocacy Insights on new and emerging payment models Reimbursement support: fact sheets and helpline for Ethicon devices 19

20 Our valuable tools are built to help improve patient access to thoracic surgery Shared decision making Shared decision making tools for thoracic surgery for patient and health care professionals Ethicon Reimbursement Support Hotline:

21 Innovative Products At the forefront of innovation to help enable the best surgical outcomes 21 FOR INTERNAL USE ONLY

22 Our approach to innovation starts with knowledge and insight TISSUE Tissue Management 2 Hemostasis ANATOMY 1 Disease State Access Visibility SURGEON AND OR TEAM Observation 3 Experience Technique TECHNOLOGY 4 Stability Precision Cost Resulting in the development of technology that meets your surgical needs 22

23 We continuously invest in innovation to address key challenges to impact thoracic procedural outcomes ECHELON FLEX TM Powered Vascular Stapler has a 26% thinner shaft vs Endo GIA, offering the greatest angle of reach in the tight intercostal space* ECHELON FLEX TM GST System can accommodate the broadest range of lung parenchyma tissue thicknesses HARMONIC HD 1000i successfully seals 100% of thoracic vessels up to 7 mm in a preclinical study * Approach angles assessed in a virtual CAD environment in the 5th intercostal space. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA ULTRA Handle (EGIAUSTND) and Endo GIA Reload with Tri-Staple Technology at 3.3 and 4.0 mm tissue thicknesses (3.3 mm: GST60T mm vs EGIA60AMT mm p<0.001; 4.0 mm: GST60T mm vs EGIA60AXT mm p<0.001). In a pre-clinical study of porcine thoracic vessels, the HARMONIC HD 1000i successfully sealed 100% (21/21) of vessels < 7mm with initial hemostasis. 23

24 ECHELON FLEX Powered Vascular Stapler The ECHELON FLEX Powered Vascular Stapler gives you a narrower anvil, thinner shaft, and more articulation than Endo GIA Curved Tip Reload with Tri-Staple Technology 26% narrower curved blunt-tip anvil* 26% thinner shaft, offering the greatest angle of reach in the tight intercostal space Designed to allow for a broader range of approach angles due to the greater manual articulation of 50 Enhanced stability on fragile vessels, providing 83% reduction in tip movement during transection *Versus leading staplers on the market as of October Approach angles assessed in a virtual CAD environment in the 5th intercostal space. Compared to the Endo GIA Curved Tip Reload with Tri-Staple technology. Based on articulation data from IFUs of each device. Benchtop testing on porcine carotid arteries. Surgeons (n=24) fired each instrument/reload once: PSE45A/ECR45W and EGIAUSTND/EGIA45AVM. Distal tip motion measurement during the firing cycle showed a median reduction of 83% and a range of reduction of 53% to 96% in tip movement of PSE45A/ECR45W vs EGIAUSTND/EGIA45AVM. Equivalence of handles, powered firing, user ergonomics and lengths between PSE45A and PVE35A substantiate inclusion of PVE35A. 24

25 ECHELON FLEX GST System* The ECHELON FLEX GST System* controls tissue movement to enable surgeons to transect as intended even on the most challenging thoracic tissue 4x less tissue slippage during firing compared to Endo GIA Reloads with Tri-Staple Technology Can accommodate the broadest range of lung parenchyma tissue thickness Exceptional staple line integrity now across a range of tissue thicknesses with each reload *System components include ECHELON FLEX Powered Plus Stapler and ECHELON ENDOPATH Reloads with Gripping Surface Technology. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA ULTRA Handle (EGIAUSTND) and Endo GIA Reload with Tri-Staple Technology at 3.3 and 4.0 mm tissue thicknesses (3.3 mm: GST60T 0.642mm vs EGIA60AMT 4.806mm P<.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT mm P<.001). Comparison of the ECHELON FLEX GST System designed to accommodate a tissue thickness range of 1.0mm to 4.0 mm (as measured with an 8g/mm2 tissue measuring device) vs the Medtronic Tri-Staple portfolio intended for a thickness range of 0.75 mm to 3.0 mm (Medtronic literature, downloaded from Medtronic website on Nov 16, 2016). Porcine tissue thickness measured at 8g/mm prior to firing. Tissue comfortably compressed to closed staple height per IFU. 25

26 HARMONIC HD 1000i Shears HARMONIC HD 1000i offers a seamless combination of unmatched precision, unparalleled strength, and optimal efficiency for improved dissection, faster transection, and more secure sealing Successfully sealed 100% of thoracic pulmonary vessels up to 7 mm in a preclinical study* Displayed overall superior dissecting capabilities when performing dissection on the pulmonary artery, pulmonary vein, azygos vein, and lymph nodes Enables improved surgical efficiency during thoracic procedures *In a pre-clinical study of porcine thoracic vessels, the HARMONIC HD 1000i successfully sealed 100% (21/21) of vessels < 7mm with initial hemostasis. Based on a pre-clinical study of lymphatic node dissection. Based on a pre-clinical study. 26

27 Our full portfolio supports your surgical and economic needs Product Solution Ethicon Medtronic Intuitive Baxter/Bard Advanced energy with articulation Advanced energy Endocutter Ultrasonic energy device with 7 mm vessel sealing Biological adjunctive hemostats TSAs Antibacterial sutures Sutures 27

28 Shaping the future of surgery in the fight against lung cancer and lung disease Our comprehensive approach helps achieve the goal of best outcomes and well-being for patients Research and Evidence Education and Training Access and Reimbursement Innovative Products 28

29 SURGICEL Essential Product Information INDICATIONS SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL ORIGINAL, SURGICEL FIBRILLAR and SURGICEL NU-KNIT Hemostats can be cut to size for use in endoscopic procedures. PRECAUTIONS Use only as much SURGICEL Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction. In urological procedures, minimal amounts of SURGICEL Absorbable Hemostat should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product. Since absorption of SURGICEL Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals. If SURGICEL Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped. Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples: controlling hemorrhage after tonsillectomy and controlling epistaxis.) Care should be taken not to apply SURGICEL Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions). ADVERSE EVENTS Encapsulation of fluid and foreign body reactions have been reported. There have been reports of stenotic effect when SURGICEL Absorbable Hemostat has been applied as a wrap during vascular surgery. Paralysis and nerve damage have been reported when SURGICEL Absorbable Hemostat was used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL Absorbable Hemostat was placed in the anterior cranial fossa. Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported. For more information, please consult your doctor or for product quality and technical questions, call

30 SURGICEL Powder Absorbable Hemostat Essential Product Information Indications SURGICEL Powder (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. Contraindications Do not inject or place SURGICEL Powder into an open blood vessel. SURGICEL Powder should not be used to control hemorrhage from large arteries. When SURGICEL Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure. SURGICEL Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation. Warnings Closing with SURGICEL Powder in a contaminated wound without drainage may lead to complications and should be avoided. SURGICEL Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances. SURGICEL Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation. Although SURGICEL Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections. Do not attempt to trim the applicator tip. Precautions SURGICEL Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems. Use only as much SURGICEL Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction. In urological procedures, minimal amounts of SURGICEL Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product. Since absorption of SURGICEL Powder could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals. If SURGICEL Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped. Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis). This applicator tip is not intended for laparoscopic or other endoscopic use. Adverse Events Paralysis and nerve damage have been reported when other SURGICEL products were used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when other SURGICEL products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS). Foreign body reactions have been reported with other products from the SURGICEL Family of Absorbable Hemostats. Burning has been reported when other SURGICEL products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported. For more information and technical questions, call Ethicon US, LLC. All rights reserved