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GERD Implant Device Approved

The FDA approved Enteryx, a permanently implanted device, to help patients with symptoms of gastroesophageal reflux disease (GERD). Enteryx prevents the reflux of stomach acid into the throat, potentially allowing patients with chronic GERD to avoid daily medications. Enteryx is approved for patients who have GERD symptoms and who require and respond to certain medications. The device is a solution made up of a polymer and a solvent that is implanted by injection during an x-ray guided endoscopic procedure into the wall of the lower esophagus. After the injection, the solvent separates away and the polymer solidifies into a spongy material intended to prevent reflux.


In clinical studies, Enteryx has been found to help eliminate or reduce the need for medications and to improve the symptoms of GERD. In a 12-month study of 85 patients, approximately 67% of participants were able to discontinue all of their medications, 9% could reduce their dose of medication by at least half, and most patients (72%) noted an overall improvement in their symptoms when compared to taking no medications prior to Enteryx implantation. While many patients had improvements in their symptoms and medication requirements, objective evaluations of the esophagus performed during the clinical trial showed evidence of persistent acid reflux in 61% of patients, and low-grade inflammation in 37% of patients at 12 months.


Enteryx is a product of Enteric Medical Technologies (Foster City, Calif.), a subsidiary of Boston Scientific, Inc.


Expanded Use for HPV Test

The HC2 High-Risk HPV DNA Test (Digene Corporation, Gaithersburg, Md.) has received FDA approval for use in conjunction with the Pap test to screen women over age 30 for human papillomavirus (HPV) infection. The test can detect high-risk types of HPV in cell DNA even before there are any conclusive visible changes to the cervical cells.


The test was originally approved to test women who had abnormal Pap test results to determine whether they needed to be referred for further examination. It can identify 13 of the high-risk types of HPV that are associated with the development of cervical cancer. The HC2 High-Risk HPV DNA Test should be used along with the Pap test, a complete medical history, and an evaluation of other risk factors.


According to the FDA, the test is not intended to screen women under 30 who have normal Pap tests because most infections in this group are short-lived and not associated with cervical cancer.


Hepatitis C Virus Assay Available

The FDA approved Bayer HealthCare LLC's (Tarrytown, N.Y.) predictive test to directly measure hepatitis C virus (HCV) RNA levels in serum or plasma. The test, Versant HCV RNA 3.0 Assay (bDNA), is the first and only FDA-approved quantitative test to measure HCV viral load levels and is intended as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment, and can identify early in the treatment process patients who may not respond to further therapy.


The Versant HCV RNA 3.0 Assay directly measures HCV viral levels in serum or plasma using branched DNA (bDNA) signal amplification technology. The test has been validated for all six HCV genotypes.


Home Monitoring System Measures INR

LifeScan, Inc. (Milpitas, Calif.) introduced the HARMONY INR Monitoring System for weekly home International Normalized Ratio (INR) testing. The new product provides clinical accuracy in a fast, simple home test for people who take warfarin, and can be used during the intervals between INR measurements taken when patients visit their health care providers or a laboratory.


To perform the test, the patient applies a drop of blood from a fingerstick to a disposable test strip that is read by the portable HARMONY Monitor. Results are displayed in 90 seconds. The patient then calls the practitioner's office to report the test results. If the INR is out of range, the primary care provider can make appropriate adjustments to the warfarin dosage.


The HARMONY system can store up to 75 test results. LifeScan provides 24-hour, 7-day/week customer service and support. This system is available by prescription only.



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