SenoRx Submits Implantable RFID Tags to FDA For Approval – Breast Tumor Surgery

This stands to change the way surgical procedures are done as relates to breast cancer and removal of tumors. Right now a wire is inserted at the time of surgery and it uses ultrasound. With the proposed process of using RFID, the tag, about as big as a piece of rice could be inserted as far as 7 days in advance of the surgery.

The product still needs to go through clinical trials to be tested thoroughly. One advantage of performing surgery in this fashion is the reduction of potential infections and if the patient happens to move during surgery, the wire could be moved, where as the RFID devices would not move. Health Beacons is the partner with the software and the RFID tags. Who would have ever thought the small RFID tags would be working internally with tumor removal. BD

Dec. 28, 2009—SenoRx, a provider of breast cancer treatment and diagnostic equipment, is working to introduce an RFID-based system that will offer radiologists a new method for marking a tumor's location prior to surgery. The solution, according to the company, promises to reduce the risk of infection, while helping surgeons to locate lesions more accurately.
Typically, a breast cancer patient goes through a one-day process in which a radiologist finds the tumor and then marks its location by inserting a wire into the lesion, so that one end of the wire protrudes from the breast after insertion. The radiologist then utilizes ultrasound, stereotactic or mammographic guidance to ensure that the tip of the wire is within the tumor's center. The surgeon can then follow the length of wire to its end, in order to pinpoint the specific location of the mass. This procedure usually requires a patient to schedule both radiological and surgical procedures on the same day the wire is inserted, to ensure against infection caused by the wire, as well as reduce the chance of the wire being dislodged. The wire could be jostled out of place, for example, as the patient moves around prior to the operation, or be inadvertently moved during the surgery itself; and in some cases, surgeons may have difficulty locating or identifying the end of the wire marking the lesion, or with radiographs.

Health Beacons first approached SenoRx with the RFID interrogator and tag in August 2008. The system involves an implantable tag approximately the size and shape of a grain of rice, as well an injector to implant the tag, and a handheld reader provided by Health Beacons. The tag consists of an 134.2 kHz RFID inlay encased in glass and complying with the ISO 11784 and 11785 standards, and its glass exterior is surrounded by a steel coil, each end of which forms a hook. The purpose of the coil and hooks is to help prevent the tag from migrating within the body.