Monday, December 17, 2007
Adiana Transcervical Sterilization System Occludes Tubes; Gets FDA Nod
Filed under: Reproductive Medicine
A pre-market application of Adiana Transcervical Sterilization System from Hologic, Inc., a Bedford, Mass company, has received an approval recommendation from the FDA Obstetrics and Gynecology Devices Advisory Panel. This minimally-invasive, non-incisional new contraception device for female sterilization works by occluding Fallopian tubes by a transcervical catheter that releases a low-level of bi-polar radio frequency ablation and a special chemical "matrix" that eventually allows the clogging of the tubes.
Here are details about the device taken from the FDA Executive Summary:
The Adiana Transcervical Sterilization System consists of three principal components:silicone matrix (one per tube);
hysteroscopic delivery catheter; and
radio-frequency (RF) generator to deliver thermal dose to tube prior to implantation. The Adiana Transcervical Sterilization System is used to place a silicone implant, called a matrix, into each fallopian tube of the female patient to effect tubal occlusion and permanent sterilization. The delivery catheter is introduced into the patient through a hysteroscope, transvaginally and transcervically. The physician will require a separate delivery catheter to place individual matrices in each of the two fallopian tubes (two delivery catheters are needed per patient since each delivery catheter contains a single matrix). A black mark on the catheter, proximal to the electrode array and matrix, is visualized to confirm correct catheter placement prior to silicone matrix delivery. Device position is confirmed by the RF generator via the position detection array.
Once placement inside the intramural section of the fallopian tube is confirmed, the distal tip of the catheter delivers RF energy to the electrode array. Thermocouples in the catheter tip are used to maintain a constant temperature of 64°C for 60 seconds (maximum of 120 seconds of treatment per tube during a single procedure in the event that a procedure is terminated due to loss of adequate tissue contact). This creates a lesion within the fallopian tube (including destruction of the endosalpinx).
After the thermal dose is delivered, the release mechanism in the catheter is then actuated to deploy the matrix in the region of the tube where the lesion was formed. The endothelial damage provided by the RF energy encourages a tissue ingrowth response (i.e., wound-healing response). The implanted matrices provide attachment sites for tissue ingrowth, which secures the matrices in place by filling the voids in the implant. The physician conducts a hysterosalpingogram (HSG) three months after matrix placement to confirm contraceptive tubal blockage.
Press release: FDA Advisory Panel Finds Hologic's Adian® Permanent Contraception Approvable ...
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