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Lower Esophageal Sphincter Augmentation With Linx
C. Daniel Smith, MD
Advances in Technology and Understanding of Esophageal Disease
January 11, 2013Mayo Clinic Education Center
Phoenix, Arizona
1
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
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Fundoplication
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• 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
GERD - Current Treatment Options
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No.
GER
D P
atien
tsN
o. G
ERD
Pati
ents
Severity of Symptoms and Dissatisfaction Severity of Symptoms and Dissatisfaction MildMild SevereSevere
PPI TherapyPPI TherapyPPI TherapyPPI Therapy
Fundoplication SurgeryFundoplication Surgery
FundoplicationFundoplicationSurgerySurgery
Fundoplication
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• 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
Fundoplication – Why Not?
6
• 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
GERD - Current Treatment Options
7
No.
GER
D P
atien
tsN
o. G
ERD
Pati
ents
Severity of Symptoms and Dissatisfaction Severity of Symptoms and Dissatisfaction MildMild SevereSevere
PPI TherapyPPI Therapy
FundoplicationFundoplicationSurgerySurgery
Therapy GapTherapy Gap
No standard treatment for Gap patientsNo standard treatment for Gap patients
Targeted Linx Targeted Linx populationpopulation
Linx
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FDA Approved March 2012 - PMA
Torax Medical
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Linx
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Linx – Barium Swallow
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Linx – Procedure
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Linx
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LINX Bead
Fibrous Capsule
In-tact Muscular
Layer
Mucosa
Clinical Studies - Linx
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Median Acid Exposure - Linx
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n=100
n=96
P<0.001
Median GERD-HRQL - Linx
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P<0.001n=100
n=100
n=95 n=90 n=85
Heartburn - Linx
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P<0.001
n=100
n=95 n=90n=84
- Interfere with activities of daily living- Primary reason for visit
Regurgitation - Linx
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P<0.001
n=100
n=95 n=90 n=84
- Constant regurgitation, presence of aspiration- Predictable with position change
PPI Use - Linx
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P<0.001
n=100
n=95 n=90 n=84
Time Course of Dysphagia - Linx
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Patient Satisfaction - Linx
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P<0.001
n=100
n=95n=90
n=84
Gas Bloat - Linx
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P<0.001
n=100
n=95 n=90 n=84
Serious Adverse Event - Linx
23
Subject ID Event Description Status
03-005-004 DysphagiaNausea
Explanted 31 days after implant Resolved
03-004-004 DysphagiaOdynophagia
Explanted 93 days after implant Resolved
03-008-021 Dysphagia Explanted 21 days after implant Resolved
03-008-018 Pain
Vomiting
Hospitalized for pain;
Explanted 357 days after implant for vomiting
Resolved (pain)
Ongoing, no follow-up deemed necessary (vomiting)
03-008-020 Vomiting Hospitalized 2 days after implant for <2 days
Resolved
03-018-002 Nausea Hospitalized 2 days after implant for <2 days
Resolved
No device migration or erosion
The Successful LINX Patient
Post-LINX% of Pts 3 Years
8%
2%
2%
1%
1%
12%
11%
Baseline% of Pts Characteristic
100% Daily PPI dependence
70% Reflux affecting their sleep on a daily basis
76% Reflux affecting their food tolerances on a daily basis
57% Moderate or severe regurgitation including aspirations
55% Severe heartburn affecting their daily life
51% Experiencing extra esophageal symptoms in addition to heartburn and/or regurgitation
40% Esophagitis
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 +• Hiatal hernia < 3cm• Normal esophageal motility
• No active esophagitis > grade b• No Barrett’s• BMI < 35
Summary / Conclusion - Linx
27
• 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