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

4

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

5

• 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?

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• 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

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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 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

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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

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• 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