New Type of Latex Glove May be Safe Alternative
The first product made from a new form of natural rubber latex, guayule latex, has been approved by the FDA. The Yulex Patient Examination Glove, a product of the Yulex Corporation (Maricopa, AZ), is derived from the guayule bush, which is native to the southwestern United States.
According to the FDA, even people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins. Anywhere from 3% to 22% of all healthcare workers are sensitized to traditional latex. Gloves from guayule latex may prove to be a safer alternative for some people with sensitivity to traditional latex, without sacrificing important properties of traditional latex, such as flexibility and strength.
For more information, visit http://www.yulex.com.
FDA Approves Device that Measures Arterial Plaque
InfraReDx, Inc.'s (Burlington, Mass.) LipiScan Coronary Imaging System was approved by the FDA to identify plaques in coronary arteries that contain lipid cores. The catheter-based product uses near-infrared spectroscopy to identify these plaques in the coronary arteries of patients already undergoing cardiac catheterization.
According to the company, the device is expected to be of value in selecting medical, stenting, or surgical therapy for coronary lesions. The device is also likely to be of value in research to assess the effect of new anti-atherosclerotic agents on lipid core plaque burden.
LipiScan Coronary Imaging System's console displays the scan results on a "chemogram," a digital, color-coded map of the location and intensity of lipid core-containing plaques of interest in the artery. A lipid core burden index is also reported, which is a measure of the total amount of lipid core-containing plaques of interest in the coronary artery. The device examines each artery in less than 2 minutes and does not require the interruption of blood flow.
For more information, visit http://www.infraredx.com.
Test Detects Lupus and Lupus-Like Disorders
Corgenix Medical Corporation (Denver, Colo.) received FDA approval of the IgG Anti-AtherOx Test Kit to detect antibodies in people with autoimmune diseases. The test is indicated for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein with beta2-glycoprotein I in individuals with lupus and antiphospholipid syndrome.
According to Corgenix, the test will be an important addition to other phospholipid products used to identify patients with thrombosis-associated antibodies and provides information vital for the treatment of people with lupus and antiphospholipid syndrome.
Studies have suggested there is an association of antibodies to the AtherOx complex with vascular thrombosis, particularly arterial thrombosis, in patients with autoimmune diseases. Several studies showed that the measurement of the AtherOx antibody was significantly better than conventional anti-cardiolipin testing in identifying patients with vascular complications.
For more information, visit http://www.corgenix.com.
FDA Brochure Helps Track Medications
The FDA has published "My Medicines," a brochure to help consumers track the medications they use. "My Medicines" is available in English, Spanish, and 11 other languages, and is offered by the agency's Office of Women's Health.
The publication features a chart that lets patients list information about the prescription drugs they are taking, including their names, how much is taken, when they are taken, what condition they treat, and the number of refills.
Advice is also offered about how to use product labeling information, how to avoid problems with medications, and questions patients should ask their healthcare provider or pharmacist about their prescriptions.
The brochure is available online at: http://www.fda.gov/womens/taketimetocare/http://mymeds.html.