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Hysteroscopic Sterilization Device Nears Market


 

The Adiana transcervical sterilization system appears to be easy to use, safe, and effective, according to phase III data, Alan Johns, M.D., reported at the annual meeting of the AAGL.

The Adiana Complete system is available only for experimental use, but U.S. Food and Drug Administration submission is anticipated in mid-2006, said Dr. Johns, one of the clinical investigators in the trial.

The FDA approved Essure, currently the only nonincisional approach to female sterilization, in November 2002. The Adiana system “is the next step in the evolution of hysteroscopic devices,” Dr. Johns said in an interview. It may be better than the Essure simply because it doesn't require as much manipulation and the whole device is altogether shorter and easier to put in and cannulate, he said. “More importantly, in contrast to the Essure system, after the Adiana matrix has been deployed, nothing remains in the endometrial cavity.”

This may be important in women who later choose to undergo in vitro fertilization or endometrial ablation, because these options can be limited by the presence of a portion of a device in the endometrial cavity, he said.

The Adiana system also differs from Essure in that it uses radio frequency energy before placement of the polymer matrix in the fallopian tubes. This process is designed to stimulate vascularized tissue ingrowth into the matrix material, said Dr. Johns of Fort Worth, Tex. He accepted payment to enroll and treat patients in the trial but said he has no financial interest in Adiana Inc.

As of Sept. 30, 2005, the Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women (EASE) study had enrolled 770 women at 16 sites. Almost half (47%) were aged 28–33 years. A total of 655 patients were taken for hysteroscopy, and 10 were excluded for hysteroscopic findings. The remaining 115 patients either withdrew from the study or were excluded from the study protocol.

Treatment was attempted in 645 patients and bilateral placement was achieved in 614 (95%).

This placement rate is comparable with that attained by Essure in its clinical trials, he said. Lateral location of the ostia is the most common reason for failure of placement of hysteroscopic sterilization devices.

The average procedure time from insertion to removal of the hysteroscope was 12 minutes. Local and oral anesthesia was used in 35% of patients, local anesthesia plus intravenous sedation in 48%, and local plus intravenous analgesia in 17%. Nine patients were lost to follow-up or are awaiting 3-month hysterosalpingogram (HSG).

Failure of tubal occlusion occurred in 26 (4.29%) women, and there were two pregnancies. One occurred after proper placement of the device and HSG confirmation of occlusion. The second occurred when a physician misinterpreted the HSG and retreated the patient but placed the device in the occluded tube instead of the patent tube. There were no device-related significant adverse events. One procedure-related incident of hyponatremia was reported. All other events were minor and included spotting, cramping, and headache.

Radiofrequency energy is used before the Adiana implantable matrix is placed in the fallopian tubes. Adiana, Inc.

After the Adiana polymer matrix has been deployed, nothing remains in the endometrial cavity. Adiana, Inc.

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