Advances in Managing GERD - LINX
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Slides from recent presentation at Mayo Clinic course on advances in gastroenterology. These are the slides that are a part of the video presentation of this same talk.
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Advances in Managing GERD - LINX
- 1. Lower Esophageal Sphincter Augmentation With Linx Advances in Technology and Understanding of Esophageal Disease January 11, 2013 Mayo Clinic Education Center Phoenix, Arizona C. Daniel Smith, MD 1
- 2. Conflict of Interest / Disclosures - Co-PI for one of the sites who participated in the Pivotal Trial - Advisor/consultant to Torax for preparation of the presentation to FDA - Joined company for presentation to FDA - Paid consultant to company helping with safe and successful introduction of Linx to care of GERD patients 2
- 3. Fundoplication • Great operation • Select patients do very well • Superior to PPIs • Significant positive impact on natural history of GERD • Multiple studies have confirmed its effectiveness and role in treatment of GERD 3
- 4. GERD - Current Treatment Options Fundoplication Surgery PPI Therapy PPI Therapy Fundoplication Surgery st ne t a P DRE G. o N Severity of Symptoms and Dissatisfaction i Mild Severe 4
- 5. Fundoplication • Use of fundoplication for GERD has peaked, use slowly declining • GIs have largely stopped referring patients except for desperate or complicated cases • Most cases are done for complicated conditions (redo, large hiatal hernia, Barretts, severe refractory GERD • PPIs remain treatment of choice for all but the most severe cases of GERD 5
- 6. Fundoplication – Why Not? • Technical failures – inconsistent and questionable outcomes • Lack of standardized approach/technique • Inconsistent use – patients still have fundoplication performed without objective confirmation of GERD • Patients are afraid of the operation – troubling side- effects of gas bloat and excess flatus or perception that failure rate is 50% • Competing treatments – primarily PPIs, some endolumenal approaches 6
- 7. GERD - Current Treatment Options No standard treatment for Gap patients PPI Therapy Targeted Linx population Therapy Gap Fundoplication Surgery st ne t a P DRE G. o N Severity of Symptoms and Dissatisfaction i Mild Severe 7
- 8. Linx FDA Approved March 2012 - PMA 8
- 9. Torax Medical 9
- 10. Linx 10
- 11. Linx – Barium Swallow 11
- 12. Linx – Procedure 12
- 13. Linx LINX Fibrous Bead Capsule In-tact Muscular Layer Mucosa 13
- 14. Clinical Studies - Linx 14
- 15. Median Acid Exposure - Linx n=100 P<0.001 n=96 15
- 16. Median GERD-HRQL - Linx n=100 P<0.001 n=100 n=95 n=90 n=85 16
- 17. Heartburn - Linx - Interfere with activities of daily living - Primary reason for visit n=100 P<0.001 n=84 n=95 n=90 17
- 18. Regurgitation - Linx - Constant regurgitation, presence of aspiration - Predictable with position change n=100 P<0.001 n=95 n=90 n=84 18
- 19. PPI Use - Linx n=100 P<0.001 n=95 n=90 n=84 19
- 20. Time Course of Dysphagia - Linx 20
- 21. Patient Satisfaction - Linx n=95 n=84 n=90 P<0.001 n=100 21
- 22. Gas Bloat - Linx P<0.001 n=100 n=95 n=90 n=84 22
- 23. Serious Adverse Event - Linx Subject ID Event Description Status 03-005-004 Dysphagia Explanted 31 days after implant Resolved Nausea 03-004-004 Dysphagia Explanted 93 days after implant Resolved Odynophagia 03-008-021 Dysphagia Explanted 21 days after implant Resolved 03-008-018 Pain Hospitalized for pain; Resolved (pain) Vomiting Explanted 357 days after implant for Ongoing, no follow-up vomiting deemed necessary (vomiting) 03-008-020 Vomiting Hospitalized 2 days after implant for <2 Resolved days 03-018-002 Nausea Hospitalized 2 days after implant for <2 Resolved days No device migration or erosion 23
- 24. The Successful LINX Patient Post-LINX Baseline % of Pts % of Pts Characteristic 3 Years 100% Daily PPI dependence 8% 70% Reflux affecting their sleep on a daily basis 2% 76% Reflux affecting their food tolerances on a daily 2% basis 57% Moderate or severe regurgitation including 1% aspirations 55% Severe heartburn affecting their daily life 1% 51% Experiencing extra esophageal symptoms in 12% addition to heartburn and/or regurgitation 40% Esophagitis 11%
- 25. Patient Selection - Linx INDICATION The LINX Reflux Management System is indicated for patients diagnosed with GERD as defined by abnormal pH testing, who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux. • Age 18 + • No active esophagitis > grade b • Hiatal hernia < 3cm • No Barrett’s • Normal esophageal motility • BMI < 35
- 26. Summary / Conclusion - Linx • Device closely reproduces native LES function - dynamic • Improvement over current surgical options • Addresses a significant unmet need • Positively transforms patients’ lives • LINX would be a tremendous positive addition to current options for GERD 27
Hinweis der Redaktion
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- With this understanding, there have been several key principles that have guided our efforts. These include isolating the unpredicatble variation of the urgent/emergent practice, Natural Variation, from the manageable and modifiably variation of the elective practice, Artificial Variation. Design a process to create a predictable and more consistent surgical schedule, Limit the number of changes we make to the elective schedule on the day of surgery, and maintain the integrtity of our surgical teams so that patients can benefit fomr the expertise and quaity we deliver through our team-based care.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- With this understanding, there have been several key principles that have guided our efforts. These include isolating the unpredicatble variation of the urgent/emergent practice, Natural Variation, from the manageable and modifiably variation of the elective practice, Artificial Variation. Design a process to create a predictable and more consistent surgical schedule, Limit the number of changes we make to the elective schedule on the day of surgery, and maintain the integrtity of our surgical teams so that patients can benefit fomr the expertise and quaity we deliver through our team-based care.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
- Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.