Full Sense Device

Full Sense Device
• Randal S Baker MD FACS
• Grand Rapids, Michigan USA
IFSO Disclosure
• Randal S Baker MD FACS
• Consulting/Speaking:
– Ethicon
– Baxter
• Commercial Interests
– BFKW LLC - Partner
Eureka Moment
Position of
Esophageal
Stent
Location of
Strictures
Concept Finalist
Selected to provide pressure and optimize the function of the
gastro esophageal junction
Pressure Related Satiety Scale
• Vomiting
• Nausea
• Stuffed
• Fullness
• No Hunger
• Hunger
GE Junction Preservation
Full SenseTM Device - Evolution
CE-Mark
Prototype Device
Randomized
Study Device
Initial Trial Device
Second Generation
Device without Barbs
First Generation
Device with Barbs
Confidential
8
Laparoscopic view of cardiac disk
Animal Weight Loss Data
Human Trial I Data
Mean BMI
= 44
0%
EXCESS BODY WEIGHT LOSS
0
13
18
35
46
68
-5%
-10%
-15%
-20%
-25%
Device Removed
-30%
EBWL = 28.5%
78
84
119
Days
Satiety Results
Completely Full 10
9
P<.0001
Satiety
8
7
6.3
P<.0001
6
5
7.5
4.3
4
3
2.1
2
Most Hungry
1
Before Meals Device
Before
Removed
BeforeMeals
MealsDevice
No Device
After Meals Device
After
Device
Removed
AfterMeals
Meals
No Device
With the device in place, patients reported that they were only slightly hungry prior to meals
and were “pleasantly satisfied” after eating.
Hunger went away after eating just small amounts of food.
Randomized Study Results
Cross Over
Mean BMI = 37
Consistent Weight Loss And
Metabolic Improvement
• All patients continue to lose weight until device is
removed. Higher pressure = steeper weight loss.
• 14 studies confirm same pattern of weight loss.
• Metabolic Considerations:
– Significant metabolic improvements similar to
RYGB and Sleeve. *
– Hypothesis: Device pressure in stomach causes
decreased bowel transit time and increased
incretin response.
*IFSO 2013 Presentation
Anti-Migration
Tethers
Antimigration Strategy
• Temporary: Endoscopic suture or clip.
• Long Term: Mucosal Capture and Tissue in growth.
– “Locked in” by 2-3 weeks.
Deployment Device
Deployment Over Scope
Clinical Considerations
• More direct and continuous than food based
scenario.
• Significant satiety at baseline and fullness with
eating and drinking.
• No non-responders in any study.
• Patients continue to lose weight until device is
removed (88% mean EBWL at 8.4 months).
• Long Term Implant requires adjustability.
• Metabolic improvements.
Benefits
•
•
•
•
•
•
No incisions.
Potential outpatient sedation only.
Service overweight and obese population.
Children and adolescents.
More cost effective.
Offer second chance to post bariatric patients who
have regained weight.
• Safer and less invasive thus more readily adopted by
population.
• Service patients with metabolic disease but not
obesity.
Bariatric Surgery Only
Impacting less than 1%
Of Eligible Patients
Full Sense Status
• Design Freeze for device – August 2014.
• CE Mark in progress.
– ISO Quality Achieved.
• Centers in Europe and Canada Identified.
– Begin training this fall.
– Those centers will be training centers.
• Expected CE Mark in 2015
Before and After