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The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:

• The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
• The liver in bariatric procedures
• The prostate and periprostatic tissue in prostatectomy procedures
• The colon, rectum, and pericolorectal tissue in colorectal procedures

The Grasper Tip 12.5 is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:

• The pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures

Pediatric use:

The Magnetic Surgical System is indicated for use in adolescents (12-21) within a BMI range of 20 to 34 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:

• The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures

The Magnetic Surgical System comprises two hand-held instruments, the Magnetic Grasper and the external Magnetic Controller. The Magnetic Grasper, disposable and provided sterile for single use, comprises two main components: a detachable Grasper Tip (6.5cm overall length) and a shaft with Handle. An optional 12.5cm length Grasper Tip (also single use, disposable, and provided sterile) may be used as a replacement for the 6.5cm Grasper Tip and can be used interchangeably with the Shaft.

The Magnetic Grasper is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible >= 10 mm laparoscopic port to the surgical site and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller.

The Magnetic Controller is a non-sterile, reusable unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

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