New FDA approvals

FDA Approvals: Lunar iDXA, Urgent PC, MimyX

Oct. 28, 2005 ? The U.S. Food and Drug Administration (FDA) has approved a total-body dual-energy x-ray absorptiometry system for use as an aid in the detection and diagnosis of osteoporosis, and for monitoring subsequent treatment; a percutaneous tibial nerve stimulation system for the treatment of overactive bladder symptoms; and a hydrogel dressing for the management and relief of burning and itching associated with atopic and other dermatoses.

DXA System (Lunar iDXA) Assesses Bone Density, Body Composition, Fat Distribution

The FDA approved in October a total-body dual-energy x-ray absorptiometry (DXA) system (Lunar iDXA, made by GE Healthcare, a unit of General Electric Co.) for use as an aid in the detection and diagnosis of osteoporosis, and for monitoring subsequent treatment.

The system also enables simultaneous assessment of total and regional body composition and fat distribution. It can be used to measure patients weighing up to 400 lb, allowing its use in larger patients such as professional athletes who have traditionally been unable to receive a comprehensive diagnosis due to their size.

According to a company news release, the device offers improved precision of measurement of bone and image resolution/quality to allow tracking of previously undetectable changes in bone health. Its use is intended to promote earlier diagnosis of osteoporosis and more accurate treatment monitoring.

Neuromodulation Device (Urgent PC) for the Treatment of Overactive Bladder

The FDA approved in October a percutaneous tibial nerve stimulation system (Urgent PC, made by Uroplasty, Inc.) for the minimally invasive treatment of overactive bladder symptoms such as urinary urgency, urinary frequency, and urge incontinence.

The nonsurgical system is designed for use in an office setting and consists of a small 34-G needle electrode, surface electrode, lead wire, and handheld low-voltage (9 volts) electrical generator with adjustable pulse intensity (0-10 mA), a fixed pulse width of 200 ?s, and a frequency of 20 Hz.

The percutaneous needle is inserted approximately two inches cephaled to the medial malleous and attached to the lead wire and electrode. The stimulator is then turned on and the amplitude slowly increased until the patient's large toe begins to curl, the toes fan out, or the entire foot extends to indicate proximity to the nerve bundle.

The amplitude is then reduced slightly and treatment continues for 30 minutes, during which electrical impulses are transmitted to the sacral nerve plexus via the tibial nerve. Treatments are performed on a once-weekly basis.

According to a company news release, significant reductions in urge frequency and intensity have been observed after approximately 12 weeks; no significant adverse effects were reported.

Once symptoms have abated, treatment frequency may be reduced. If symptoms reappear or increase in severity, the last previously effective treatment schedule should be reinstated.

The neuromodulation system was previously approved by the European Commission in 2003.

Nonsteroidal Dressing (MimyX) for the Treatment of Dermatoses

The FDA approved in July a nonsteroidal dressing (MimyX Cream, made by Stiefel Laboratories, Inc.) for the management and relief of burning and itching associated with atopic dermatitis, allergic-contact dermatitis, radiation dermatitis, and other physician-diagnosed dermatoses in adult and pediatric patients.

According to a company news release, the hydrogel formulation mimics components of the stratum corneum, thereby restoring barrier function without adversely affecting the immune system. It is also free of potentially allergenic emulsifiers, perfumes, and dyes.

Although the product was also approved for nonprescription use to treat general symptoms such as burning and itching associated with common types of skin irritation, it is currently available by prescription only.

The approval was based on data from safety and efficacy studies showing the dressing to be substantially equivalent to currently marketed products (Biafine radiation emulsion, made by Laboratoire Medix; and Sinclair wound and skin emulsion, made by Sinclair Pharmaceuticals, Ltd.).