Insulin delivery in a disposable pen
Sanofi-Aventis announced the availability of the Apidra SoloSTAR (insulin glulisine injection), a prefilled disposable pen containing the rapid-acting insulin analog Apidra, indicated to improve glycemic control in adults and children 4 years of age and older with type 1 diabetes or adults with type 2 diabetes.
The availability of Apidra SoloSTAR follows the approval and launch of Lantus SoloSTAR (insulin glargine [rDNA origin]) in 2007. Apidra SoloSTAR and Lantus SoloSTAR are designed with completely different colors to help patients differentiate between the two pens, which are intended for use with two very different types of insulins (rapid-acting vs. long-acting). The differentiation of the Apidra SoloSTAR and Lantus SoloSTAR was shown in a specific comparative study. Nevertheless, before using Apidra SoloSTAR or Lantus SoloSTAR, patients should carefully examine the labeling on the pen to ensure they are using the correct one.
Rapid test for avian influenza A
The FDA approved Arbor Vita Corporation's (Sunnyvale, CA) AVantage A/H5N1 Flu Test, a new, more rapid test for the detection of influenza A/H5N1, the subtype of avian influenza A virus that can infect humans.
The test detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. In less than 40 minutes, the test identifies a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Other tests take 3 to 4 hours to produce results.
In clinical studies, the test correctly identified the absence of infection in more than 700 specimens and correctly detected the presence of the virus subtype in 24 cultured specimens from infected patients.
Remote monitoring device approved
ExpressMD Solutions (Berkeley Heights, NJ) has received FDA approval for the Electronic House Call System. The system will be used by healthcare professionals who manage patients with chronic conditions such as heart disease, chronic obstructive pulmonary disease, and diabetes.
Patients can use the monitoring devices in their home to measure their vital signs and to motivate them through education and reminders. The system securely transmits this information to its data center, making it conveniently available to each licensed care provider via a secure website. By remotely receiving patient data daily, licensed care providers can adjust treatment accordingly and provide an enhanced level of care.
Label change for fibroid treatment
InSightec Ltd. (Tirat Carmel, Israel) has received FDA approval for a change to the labeling of the company's ExAblate 2000 MR-guided Focused Ultrasound system for the treatment of women with non-hysteroscopically resectable uterine fibroids. The system is the only noninvasive treatment for uterine fibroids available today.
The new labeling states that practitioners can treat up to 100% of the fibroid compared with its previous restriction to treat only up to half the fibroid tissue. The labeling change was based on growing evidence supporting the system's safety and efficacy, including a study that showed patients experience longer and improved symptom reduction as a greater volume of fibroid is destroyed.