Lower Esophageal Sphincter  Augmentation With Linx    Advances in Technology and Understanding of Esophageal Disease      ...
Conflict of Interest / Disclosures- Co-PI for one of the sites who participated in the Pivotal Trial- Advisor/consultant t...
Fundoplication• Great operation• Select patients do very well• Superior to PPIs• Significant positive impact on natural hi...
GERD - Current Treatment Options                                         Fundoplication Surgery                           ...
Fundoplication• Use of fundoplication for GERD has  peaked, use slowly declining• GIs have largely stopped referring patie...
Fundoplication – Why Not?• Technical failures – inconsistent and  questionable outcomes• Lack of standardized approach/tec...
GERD - Current Treatment Options                                No standard treatment for Gap patients                    ...
LinxFDA Approved March 2012 - PMA                                8
Torax Medical                9
Linx       10
Linx – Barium Swallow                        11
Linx – Procedure                   12
LinxLINX   FibrousBead   Capsule        In-tact       Muscular         Layer       Mucosa           13
Clinical Studies - Linx                          14
Median Acid Exposure - Linxn=100                     P<0.001                       n=96                                   ...
Median GERD-HRQL - Linxn=100                       P<0.001        n=100                n=95   n=90      n=85              ...
Heartburn - Linx        - Interfere with activities of daily living           - Primary reason for visitn=100             ...
Regurgitation - Linx        - Constant regurgitation, presence of aspiration           - Predictable with position changen...
PPI Use - Linxn=100                      P<0.001        n=95   n=90             n=84                                      ...
Time Course of Dysphagia - Linx                                  20
Patient Satisfaction - Linx        n=95                n=84                 n=90                                   P<0.001...
Gas Bloat - Linx                      P<0.001n=100        n=95   n=90         n=84                                   22
Serious Adverse Event - Linx Subject ID          Event                   Description                           Status03-00...
The Successful LINX Patient                                                               Post-LINXBaseline               ...
Patient Selection - Linx                          INDICATION    The LINX Reflux Management System is indicated for patient...
Summary / Conclusion - Linx• Device closely reproduces native LES  function - dynamic• Improvement over current surgical o...
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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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  • 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.
  • Advances in Managing GERD - LINX

    1. 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. 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. 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. 4. GERD - Current Treatment Options Fundoplication Surgery PPI Therapy PPI Therapy Fundoplication Surgeryst ne t a P DRE G. o N Severity of Symptoms and Dissatisfaction i Mild Severe 4
    5. 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. 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. 7. GERD - Current Treatment Options No standard treatment for Gap patients PPI Therapy Targeted Linx population Therapy Gap Fundoplication Surgeryst ne t a P DRE G. o N Severity of Symptoms and Dissatisfaction i Mild Severe 7
    8. 8. LinxFDA Approved March 2012 - PMA 8
    9. 9. Torax Medical 9
    10. 10. Linx 10
    11. 11. Linx – Barium Swallow 11
    12. 12. Linx – Procedure 12
    13. 13. LinxLINX FibrousBead Capsule In-tact Muscular Layer Mucosa 13
    14. 14. Clinical Studies - Linx 14
    15. 15. Median Acid Exposure - Linxn=100 P<0.001 n=96 15
    16. 16. Median GERD-HRQL - Linxn=100 P<0.001 n=100 n=95 n=90 n=85 16
    17. 17. Heartburn - Linx - Interfere with activities of daily living - Primary reason for visitn=100 P<0.001 n=84 n=95 n=90 17
    18. 18. Regurgitation - Linx - Constant regurgitation, presence of aspiration - Predictable with position changen=100 P<0.001 n=95 n=90 n=84 18
    19. 19. PPI Use - Linxn=100 P<0.001 n=95 n=90 n=84 19
    20. 20. Time Course of Dysphagia - Linx 20
    21. 21. Patient Satisfaction - Linx n=95 n=84 n=90 P<0.001n=100 21
    22. 22. Gas Bloat - Linx P<0.001n=100 n=95 n=90 n=84 22
    23. 23. Serious Adverse Event - Linx Subject ID Event Description Status03-005-004 Dysphagia Explanted 31 days after implant Resolved Nausea03-004-004 Dysphagia Explanted 93 days after implant Resolved Odynophagia03-008-021 Dysphagia Explanted 21 days after implant Resolved03-008-018 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 days03-018-002 Nausea Hospitalized 2 days after implant for <2 Resolved days No device migration or erosion 23
    24. 24. The Successful LINX Patient Post-LINXBaseline % 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. 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. 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
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