Gastric Sleeve Magnetic Implant

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$99,936.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43DK083889-01A2
Award Id:
96021
Agency Tracking Number:
DK083889
Solicitation Year:
n/a
Solicitation Topic Code:
NIDDK
Solicitation Number:
n/a
Small Business Information
3DT HOLDINGS, LLC, 251 N. Illinois Street, INDIANAPOLIS, IN, 46204
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
804419740
Principal Investigator:
JOSE NAVIA
() -
GKASSAB@3DTHOLDINGS.COM
Business Contact:
JENNIFER RHODES
() -
jrhodes@3dtholdings.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): The occurrence of obesity is increasingly growing, and it has been projected that 40% of the US population will be obese by the year 2025. The World Health Organization estimates over 1.6 billion adults (age 15+) are ov erweight, and at least 400 million are considered obese. In response, there has been increasing interest in the surgical treatment of morbid obesity with the application of laparoscopic techniques. Our major objective is to establish the safety and efficac y of a Vertical Sleeve Gastrectomy, VSG-like device referred to as the gastric sleeve implant (GSI). The major advantage of GSI is that it does not require gastrectomy and hence leaves the anatomy and physiology of the stomach intact. Furthermore, the impl ant is reversible and can be removed if desired by the patient and physician. In phase I of this SBIR, we will focus on the validation of the GSI in an in vivo dog model. Therefore, our specific aim is to evaluate the safety and efficacy of a reversible GS I for weight loss in a group of dogs. The device is designed to be implanted laparoscopically, and to be readily removed after implantation if desired, leaving the patient's anatomy healthy, intact, and physiologically normal. The net result of the GSI pro cedure is a vertical sleeve, or banana-shaped, food track, which is a fraction of the size of the original stomach. The stomach tissue excluded from the food track remains healthy and unharmed, but the digestive volume is restricted to limit the patient's food intake. The GSI mimics the benefits of the increasingly popular VSG, but it inherently avoids some of the shortcomings of the VSG and other commonly used bariatric procedures. These current procedures all suffer from one or more of the following short comings: 1) Leaks and complications, especially from staple lines; 2) Nutritional deficiencies from malabsortive therapies; 3) Frequent follow-up appointments for adjustments; and 4) Insufficient and/or unsustained weight loss amongst others. The design of the proposed GSI and our preliminary data address some of these shortcomings. PUBLIC HEALTH RELEVANCE: The major objective of this proposal is to establish the safety and efficacy of an implant bariatric device. The major advantage of this weight l oss device is that it does not require excision and removal of the stomach and hence leaves the anatomy and physiology of the stomach intact. Furthermore, the implant is reversible and can be removed if desired by the patient and physician leaving the stom ach healthy and intact.

* information listed above is at the time of submission.

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