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Clinical Trials

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The SEAM trial is an FDA approved research study using a Self-Forming Magnet Anastomosis Device for ileostomy reversals.

What Are Self-Forming Magnets (SFM) & How Do They Work?

The Self-Forming Magnet study device is a pair of eight-sided magnets that are made, in part, of a metal containing nickel-titanium. The Self-Forming Magnet study device is used to form the connection (also called an “anastomosis”) between two parts of the bowel to reverse the ileostomy.

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Temporary Magnets 

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Permanent Staples 

Unlike permanent staples or absorbable sutures, the magnets pass through the gastrointestinal tract after the anastomosis is formed and leave no permanent implant inside the patient.

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Sutureless

End to End

Anastomosis by

Magnetic Compression

The GIW 21-002 clinical study is underway at select sites across the U.S.

 

If you are a patient between the ages of 18 and 80 planned to undergo a loop ileostomy reversal surgery and would like to be considered for the study, click here. 

GIW Surgical Devices 21-002 is limited by U.S. law to investigational use and is not approved for sale or distribution in the U.S.

*The self-forming Magnet Device is considered an investigational device by the United States Food and Drug Administration (FDA) as it has not been approved for sale by the FDA.

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