Science & Evidence

Science & Evidence: Magnetic Compression Anastomosis, MagDI™, and Metabolic Surgery

An educational, source-cited overview of the regulatory, technological, clinical, and institutional evidence relevant to magnetic compression anastomosis and the MagDI™ System in metabolic and bariatric surgery pathways.

FDA Regulatory Status

MagDI™ System — Precise FDA Language

The MagDI™ System by GT Metabolic received FDA De Novo marketing authorization for the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. FDA documentation states that the effects of the device on weight loss were not studied.

De Novo authorization granted July 2, 2024 (DEN240013). The second-generation MagDI™ System with the 40 mm DI Magnet and 50 mm DI Magnet received U.S. FDA 510(k) clearances in October 2024 and February 2025 respectively, identified by GT Metabolic as K242086 and K243359.

GT Metabolic Technology

About MagDI™ Technology

GT Metabolic describes the MagDI™ System as a magnetic compression anastomosis technology designed to support creation of a side-to-side duodeno-ileal anastomosis. GT Metabolic describes the technique as incisionless, sutureless, and staple-free for the anastomosis creation step, with the device designed to pass from the body after the anastomosis has formed.

Indication, exactly as authorized: “The GT Metabolic MagDI System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body.

Clinical Studies

Clinical Studies and Ongoing Research

GT Metabolic clinical study materials describe a prospective, single-arm, multi-center investigation of the MagDI™ System, with continued follow-up of enrolled patients. Published evidence continues to evolve; long-term outcomes remain under continued evaluation.

Guidelines

Bariatric and Metabolic Surgery Context

Decisions about metabolic and bariatric surgery should be grounded in current professional guidance — including the 2022 ASMBS/IFSO Indications for Metabolic and Bariatric Surgery, ADA Standards of Care in Diabetes, and ASMBS clinical resources.

Institutional Experience

Obesity Control Center — Clinical Experience

MagnaMetabolic is associated with the OCC & Ariel Center metabolic health education network. Obesity Control Center publicly reports more than 30,000 procedures performed and describes a comprehensive bariatric care model that includes consultation, surgery, and long-term follow-up. OCC reports Joint Commission International accreditation, SRC accreditation as a Center of Excellence in Metabolic & Bariatric Surgery since 2010, and first-term Global Healthcare Accreditation in 2019 with second-term accreditation in 2023.

Published OCC Outcomes Data

A published ASMBS scientific presentation analyzed 19,801 bariatric surgery patients treated under a standardized program following ASMBS guidelines.

  • 19,801 patients analyzed
  • • Average BMI: 42.3
  • • Average stay: 22.4 hours
  • • 30-day morbidity: 1.2%
  • • No mortalities reported

Published outcomes reflect the study population, procedures, and time period analyzed. Individual outcomes vary and cannot be guaranteed.

For the full list of citations and primary sources, see Sources & Verification. For a deeper breakdown of mechanism, safety, and trials, see the Science & Evidence Center.
Book Consultation