Surgery News - August 2007 - (Page 8)

8 DRUG DEVELOPMENTS NEW INDICATIONS & APPROVALS SURGERY NEWS • A U G U S T 2 0 0 7 SmartSponge System, GeneSearch BLN Assay SmartSponge System (ClearCount Medical Solutions Inc.) A device designed to prevent the retention of surgical sponges by using radio frequency identification (RFID) technology to track surgical sponges tagged with RFID chips that are smaller than a dime. Recommended Usage: Cleared for marketing by the Food and Drug Administration in May for “counting and recording the number of surgical sponges, laparotomy sponges, and surgical towels used during surgical procedures.” Special Considerations: The device will be on the market in 2008, once in-hospital studies of the device are completed and the company is prepared for mass production, according to Gautam Gandhi, cofounder and chief marketing officer of ClearCount Medical Solutions. The price for the system has not yet been determined, he said. Comment: In addition to the sponges and towels embedded with the RFID tag, the system consists of the SmartBucket, a specially designed cart that contains a microcontroller unit used to scan and count the number of sponges and towels at the beginning and end of a surgical procedure, and a handheld wand used to scan the patient for retained items if the numbers don’t correlate. “By providing a count of the items entered into surgery, and a count of those discarded and moved permanently from the surgical field, personnel can be alerted to sponges that may still remain in the surgical field prior to closing the patient,” according to the FDA’s summary statement of the approval. Clearance of a device for marketing is based on the FDA’s determination that the device under review is “substantially equivalent” to legally marketed “predicate” devices used for similar indications. In the case of the SmartSponge System, the predicate devices were the Dukal Corporation’s surgical sponges and SurgiCount, Medical Inc.’s Safety-Sponge System. GeneSearch Breast Lymph Node (BLN) Assay (Veridex LLC) An in vitro test for the rapid detection of clinically relevant (greater than 0.2 mm) metastases in lymph node tissue removed from breast cancer patients. This is the first molecular-based laboratory test for detecting whether breast cancer has metastasized to nearby lymph nodes, according to the FDA. Recommended Usage: Results of this assay “can be used to guide the intraoperative or postoperative decision to remove additional lymph nodes,” according to Veridex. It may be used in conjunction with the sentinel lymph node biopsy in a patient who has been counseled on the use of this test and has been told about the test’s performance. Results are available within 30-40 minutes. Special Considerations: Postoperative histologic evaluation of permanent sections of the tissue specimen “in accordance with usual diagnostic practice” is required, according to Veridex. Comment: The reverse transcriptase–polymerase chain reaction assay detects breast tumor cell metastases in tissue obtained during a sentinel lymph node biopsy, by detecting the expression of two genes that are present in breast tissue but are scarce in nodal tissue. Positive results “suggest immediate follow-up with full axillary node dissection, while a negative test result suggests no further dissection of axillary lymph nodes,” the company press release says. In a study of 416 patients, the results of the assay were in “strong agreement” with results from extensive microscopic examination, according to an FDA statement. In almost 88% of the patients, the test accurately predicted that the cancer had metastasized, and in 94% of cases, it correctly identified women with no metastases. Compared with results of the immediate microscopic examination during surgery, in most patients the assay had fewer falsenegative results, but slightly more falsepositive results. This assay “offers a new approach to sentinel node testing,” Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said in the statement. “Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation,” he noted. —Elizabeth Mechcatie http://www.facs.org/residencysearch http://www.facs.org/residencysearch

Table of Contents Feed for the Digital Edition of Surgery News - August 2007

Contents Drug Developments News From the College Thoracic Surgery Head & Neck Surgery

Surgery News - August 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.