HiRes 90K cochlear implant re-enters the market
Advanced Bionics (Valencia, CA) announced the FDA's approval of the immediate market re-entry of the HiRes 90K cochlear implant in the United States. There had been a voluntary recall of the device in November 2010 after the company became aware of a rare issue affecting the device. Of the more than 28,000 implanted HiRes 90K devices, only 2 (0.007%) explanted devices were confirmed to have the issue.
In the months since the recall was issued, Advanced Bionics made changes to its manufacturing process to ensure that there is no effect on the safety or efficacy of the HiRes 90K cochlear implant.
FDA OKs ovarian cancer biomarker test
Fujirebio Diagnostics (Malvern, PA) has received FDA approval to market the HE4 Test in an algorithm called ROMA (HE4 EIA + ARCHITECT CA 125 II) to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.
The ROMA (Risk of Ovarian Malignancy Algorithm) test uses the results from simple blood tests, CA 125 and HE4, to identify women who are at high or low likelihood of ovarian cancer when they present with ovarian cyst or mass.
Data from a study of 472 patients show that ROMA alone was highly accurate in assigning a combined pre- and postmenopausal patient population to likelihood groups, with 93.8% of epithelial ovarian cancers correctly classified as high likelihood.
Lab test detects human hepatitis Be antigen
The ADVIA Centaur HBeAg Assay was recently approved to detect human hepatitis Be antigen (HBeAg) in a person with a hepatitis B virus (HBV) infection. HBeAg is found in the blood only when the HBV virus is active. The presence of HBeAg in the blood often disappears after the HBV virus is cleared. Detection of HBeAg in the blood can determine if a person is chronically infected with HBV or if the infection is cleared. This test is designed for use on the ADVIA Centaur and ADVIA Centaur XP systems, which run the assay and analyze the results.
This test should not be used to:
* determine the final diagnosis of HBV infection or to determine the stage of infection.
* test cord blood specimens.
* screen blood plasma, tissue donors, immunocompromised or immuno suppressed persons, or test children under the age of 17.
The test works by using a sample of the patient's blood added to a cuvette with the test chemicals. Any HBeAg present in the blood will attach to special anti-HBe antibodies to produce a light signal. The light signal is measured by the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur HBeAg Controls are used as a quality control to ensure that the test is working properly.
Three-week regimen approved to treat OA knee pain
Euflexxa (Ferring Pharmaceuticals) is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution.
It is given as a 3-week treatment regimen injected into the synovial capsule of the knee joint. This treatment is known as viscosup plementation.
The product was approved to relieve pain in the knee due to osteoarthritis. It is used in patients who have not responded to conservative treatments including exercise, physical therapy, simple analgesics such as acetaminophen. The effects of EUFLEXXA have been shown to last up to 26 weeks after injection.