1. Introduction of Mechanical Sphincter Augmentation for GERD into Practice: Early Clinical Outcomes and Keys to Successful Adoption Southern Surgical Association 125th Annual Session December 3, 2012 The Homestead Hot Springs, Virginia C. Daniel Smith, MD 1

2. Conflict of Interest / Disclosures Co-PI for Pivotal Trial Implanting Center Advisor to Torax for preparation of presentation to FDA Advisory Panel Presented clinical outcomes data to FDA Advisory Panel Paid consultant to Torax helping guide safe and successful introduction to practice2 3. Mechanical Sphincter Augmentation FDA approved March 22, 2012 Developed and tested over 10 years In US 621 implants at 41 centers (1325 world wide)* To date, 5 publications covering 244 patients (100 U.S.) followed for up to 6 years*as of October 31, 30133 4. Mechanical Sphincter Augmentation4 5. Mechanical Sphincter AugmentationLINX BeadFibrous CapsuleIn-tact Muscular Layer Mucosa5 6. Mechanical Sphincter Augmentation Normal Peristaltic Pressures 35-80 mm HgMechanical Sphincter Opening Pressure 20-25 mm HgGastric Pressures 5-10 mm HgCLOSED to RefluxOPEN to Swallowing 6 7. Linx Procedure7 8. Study Aims MSA Introduction Review early experience of introduction of MSA to mature foregut practice Assess peri-operative & early clinical outcomes Analyze patient selection & post-operative management seeking to optimize successful introduction into practice8 9. Background MSA Introduction Managed within a well established foregut surgery program Senior gastroenterologist and senior GI surgeon (20+ years of experience each) All patients underwent standardized evaluation pH testing Esophageal motility EGD Barium swallow Gastroenterologist consultation with all candidates early, selectively later in series 9 10. Patient Selection MSA Introduction Abnormal reflux study (abnormal pH or non-acid reflux on impedance pH testing) Adequate esophageal motility No active esophagitis or significant Barretts (LS) Hiatal hernia < 3cm PPI responsive GERD No prior esophageal surgery Comfortable with new device / technology 10 11. Peri-operative Care MSA Introduction All foregut patients follow clinical pathway Discharge when recovered form anesthesia and comfortable* Regular diet immediately post-op* Return to regular activity immediately unless cruroplasty*FUNDOPLICATION One month POV / contactOvernight stay PRN contact (phone, email)30 days of liquid/soft diet30 days restricted activity *Deviation from pathway for fundoplication patients 11 12. Assessment MSA Introduction Operative / procedure related complications PPI use GERD-HRQL Satisfaction with GERD condition Subsequent GI testing or interventions12 13. Study Population MSA Introduction 15010/01/11 09/10/13(interested)8268(not candidate)(implanted)04/01/12 09/26/132 (ineligible for study)218 fundo pts GERD hiatal hernia redo66 (study patients)165(lost to followup)(studied) 14. Methods MSA Introduction PATIENT DEMOGRAPHICS No. patients Age (yrs) Age > 60 Male:Female BMI BMI>30 Clinical History Hiatal hernia Barretts esophagus66 53.7 (18-86) 10 (29%) 28:38 26.0 (17.6-34.1) 16 (24%) 44 3pH % time < 4.0* DeMeester Score9.7 (0.4-31.6) 32.3 (1.4-67)*9 patients with normal pH while on PPIs, and documented non-acid reflux 14 15. Results MSA Introduction PERI-OPERATIVE DATA Successful Implantation Complications Cruroplasty 1st of series 2nd of series No. crural sutures (per case) 1st of series 2nd of series Length of stay Same day discharge66 0 37 (56%) 26/33 (79%) 12/33 (36%) 1.0 (1-4) 1.0 (1-3) 2.0 (1-4) 0.75 17 (25%)15 16. Results MSA IntroductionCLINICAL OUTCOMES Overall< 6 mon> 6 monFollow-up in 65* (mon)5.8 (1-18.6)39 (60%)26 (40%)Off PPI54/65 (83%)PPI Dose (none, PRN, QD, BID) GERD-HRQL Satisfaction (satisfied or neutral)38/46 (83%) 21/26 (81%)54,1,7,338,2,3,321,0,5,068260/65 (92%)37/42 (88%) 23/25 (92%)*1 patient lost to follow-up16 17. Results MSA Introduction ADDITIONAL TESTING / INTERVENTIONS Total Contrast Swallow EGD Dilation pH test* Esophageal motility Ulcers or Erosions Device removal13 (20%) 12 9 4 5 1 0 0*4 of 5 normalized, 1 significantly decreased17 18. Results MSA Introduction Response Over Time 120Satisfaction Off PPIs10080%6040200Overall< 6 Months6-12 Months > 12 Months 18 19. 3-6 Month Issues MSA Introduction Dysphagia Delayed yet steady recovery of bolus transit Be patient Esophageal clearance of saliva/liquid Steady & progressive improvement Be Patient Use saltine crackers to help absorb and form bolus19 20. Not a Fundoplcation MSA Introduction Minimal dissection and device under posterior vagus Regular diet immediately expect dysphagia and coach patients and nurses about this Consistent augmentation pressure results in longer recovery time until esophageal bolus transit normal More pooling of saliva and liquids in distal esophagus leading to perception of GERD and some frothy regurgitation These patients are more sensitive to symptoms due newness of procedure & device versus natural tissue Hand holding for up to a year before declaring failure 20 21. Conclusion - MSA Promising new offering for GERD Introduction to practice will require changes from how fundoplication candidates and patients are managed Improved patient education and postoperative management should facilitate optimal use and patient response IF one decides to use MSA, thoughtful patient selection and differentiation from fundoplication patients will be important for TEAM providing care21