An Innovative Magnetic Surgical System: Results From a 20 Patient Clinical Trial

I Robles, MD1, F Riquelme, MD2, M Vivanco, MD3, M Uribe, MD1, H Rivas, MD4. 1Hospital Salvador, 2Hospital Luis Tisne, 3Hospital Padre Hurtado, 4Stanford Hospital & Clinics, Stanford University

Objective of Technology

The Magnetic Surgical System (Levita Magnetics Corp) is an innovative technological platform that utilizes magnetic fields to enable laparoscopic surgery with a reduced number of trocars. The associated risks of trocars are well-known including incisional pain, scarring, infection, bowel and vascular injuries, among others. The system also allows for un-constrained, shaft-less magnetic retraction and mobilization of tissue and organs. Shafts of conventional laparoscopic instruments can be associated with operative field clutter, instrument collisions and impaired visualization. The Magnetic Surgical System has not yet received marketing authorization from the FDA.

Description of Technology and Method of Use

The Magnetic Surgical System is intended to facilitate tissue grasping, retraction and mobilization during laparoscopic surgery. The system is comprised of an external magnet and a magnetic grasper assembly with a detachable grasper tip and handle. The magnetic grasper assembly delivers and applies the detachable grasper tip to the desired target organ or tissue. The handle is then removed leaving the introduction port available for use by another procedural instrument. With the detachable grasper tip secured to the organ, the external magnet is placed over the abdominal wall and a magnetic attraction is achieved with the detachable tip. The external magnet can then be freely moved, facilitating un-constrained shaft-less tissue retraction and mobilization of the organ or tissue. At the end of the procedure, the detachable grasper tip is reconnected to the handle and removed from the patient.

Preliminary Results

The Magnetic Surgical System has recently been evaluated in a prospective clinical trial. In this trial, the principles of Good Clinical Practices (GCPs) and the International Ethical Guidelines for Biomedical Research Involving Human Subjects were followed. The investigational device was used on twenty patients indicated for a laparoscopic cholecystectomy procedure. A three-port laparoscopic technique using the Magnetic Surgical System was performed on all subjects. The primary endpoints evaluated safety and the ability of the device to adequately mobilize the gallbladder to achieve effective exposure of the targeted surgical site. The study included 17 females and 3 males, average age 42 years old (range 18-56), with an average BMI of 27.6 kg/m2 (range 20.4-33) and an average abdominal wall thickness measured by ultrasound of 2.6 cm (range 1.8- 4.6). Fifteen patients had gallbladder stones and 5 had polyps. The procedures were successfully performed in all 20 patients, with the assistance of the Magnetic Surgical System. The average time of the magnetic grasper in the abdomen was 33 minutes. No serious device related adverse events were reported through the 30-day follow-up visit. The investigators noted that the device was easy to use in all cases and provided “excellent” (N=18) and “sufficient” (N=2) exposure of the surgical site.

Conclusions / Future Directions

This initial clinical experience shows that the Magnetic Surgical System can be used to retract and mobilize tissue and organs in laparoscopic cholecystectomy procedures with a reduced number of trocars. Additional clinical evaluations in other minimally invasive surgical procedures should be considered to continue to evaluate the System’s benefits.

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