The Secret to a Successful Product Launch: - Emerson Consultants ...

Claims Matrix
Device Description: Implantable device
Indications for Use: Weight reduction in morbidly obese patients with a BMI >35 with two co-morbidities who have failed
six months of conservative weight reduction alternatives
Claim Category
Benefit Statement
describing Claim
Clinical Data
Requirements
Regulatory
Implications
Reimbursement
Risk for Approval
of Claim
Weight Reduction Reversible
Minimally Bridge to reduction
In comorbidities
invasive surgery
100% 50% Reduction Lose excess enough reversible
in Apnea glycemic postoperative
to qualify (diabetic serious for Index surgery index)
weight
without loss index Hypopnea
adverse (obstructive complications
(e.g., CABG) events sleep
apnea)
Moderate • N=300 Type Monitoring Smaller II, diagnosed population
severe of AE’s
OSA • 3 within during Sicker year 2 clinical Follow-up
population yrs trial
• Not Study Shorter insulin design duration follow-up –– 3.5
to dependent reverse 4 yrs procedure
• Can Outcome: be singlel reduction arm I
HbA1c
• Class Precedent Preclinical Pre-clinical Shorter III regulatory IDE/PMA testing drug and
&
• pathway device Precedent pilot studies
trials trials
• Precedent for Statistical No OSA long-term therapies trials
• for OSA significance claims alternate therapies will may
therapies Class be needed II to
• Regulatory support claim
pathway
precedents
• Coverage Important Collect Will payer endpoints decisions reimburse to
mandate substantiate for decisions two payers surgeries?
co-clinicamorbidities
and mandate economic %EWL
• acceptable benefit Study sites for must
coverage be within bariatric
COE network
Low
High Moderate
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