Pluromed Inc won 510(k) approval from the FDA for its Backstop polymer gel plug. The plug is used during lithotripsy kidney stone treatments that use laser or other energy sources to break up the stones. Backstop uses Pluromed’s Rapid Transition Polymers, which are liquid at low temperatures but gel at 98.6 degrees Fahrenheit. During the lithotripsy, the gel forms a plug above the stones, preventing them from moving during the procedure. Once the stones are broken, saline is used to dissolve the plug.

Endo Pharmaceuticals introduced VALSTAR(TM) (valrubicin) for the treatment of a distinct form of bladder cancer. VALSTAR is the only FDA-approved intravesical therapy for patients with Bacille Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks. VALSTAR represents a new treatment option for these patients who may otherwise have exhausted all other FDA-approved treatment alternatives, including BCG.

The FDA has approved the drug bevacizumab (Avastin), in combination with interferon alfa, as a treatment for metastatic renal cell carcinoma. Avastin is already indicated for the treatment of metastatic colorectal carcinoma, nonsmall cell lung cancer and glioblastoma, usually in combination with other agents. The latest approval was based on results from a trial of 649 people who had metastatic renal cell carcinoma and had undergone nephrectomy.

A new study has indicated that endometriosis, in which cells from the lining of the uterus grow in other regions such as fallopian tubes and ovaries, can also be quickly and accurately identified by a small test. Researchers led by Ian Fraser at the University of Sydney and Maomar al-Jefout of Mu’tah University found that a small tissue sample taken from the uterine lining with a device inserted through the vagina works just as well. This condition of the uterus, which is linked to infertility, painful periods and pain during sexual intercourse, until now could only be detected through surgery.