QMed (CE) (USOTC:QMED)
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The U.S. Food and Drug Administration said Durolane, a knee injection made by Swedish firm Q-Med AB (QMED.SK), is safe and effective.

Separately, the agency said a new type of hip implant by a unit of Johnson & Johnson (JNJ) appeared to work as well as a current generation implant.

Both products face a review by an outside panel of medical experts next week. The FDA posted a review of both products on its Web site Friday.

Durolane, which is on the market in Europe, is a gel designed for patients with oestoarthritis of the knee who haven't responded to other pain treatments.

The gel would be injected into the knee in order to help increase joint lubrication and cushioning, which in turn relieves pain. If approved by the FDA, Durolane would be marketed by Smith & Nephew PLC (SNN).

The FDA routinely brings new types of medical products to its advisory panels for review. The positive review of Durolane makes it highly likely the panel will vote to recommend the agency approve the product.

The FDA raised a few concerns about the hip implant but also gave a generally positive review, making it likely the panel will also back the device. Johnson & Johnson's Depuy Orthopaedics unit is seeking FDA approval of a hip-implant system that would use a ceramic-on-metal system instead of a metal-on-metal system used in currently approved hip implants.

The company said the new design should cut down on the amount of device wear, "which could reduce the potential for failure." The company said overall outcomes in patients who receive a ceramic-on-metal device are similar to patients who received a metal-on-metal device in terms of restoring mobility and alleviating pain.

The FDA said it will ask the panel to discuss clinical data that looked at different sizes of device components, which include a femoral head, stem and shell. The agency said it was concerned that less than 10% of patients in the study were implanted with a smaller femoral head and a certain type of shell. The FDA will also ask the panel to vote on whether it thinks the hip-implant system should be approved.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com