• BioForm Medical (San Mateo, California) reported the publication of a post-marketing multi-center, randomized, blinded comparative study of nasolabial fold treatments showing that Radiesser dermal filler was more effective than Restylane, the leading dermal filler on the market worldwide. The results of this study will be published in the February 2008 Issue of the Journal of Dermatologic Surgery, a peer-reviewed publication of the American Society of Dermatologic Surgery. The study concluded that 1) patients preferred Radiesse dermal filler two to one over Restylane; 2) patients reported higher satisfaction and indicated they were substantially more likely to return for future treatments with Radiesse filler than with Restylane; 3) at all time points through 12 months (nine months after the second injection), Radiesse filler was found to provide greater improvement than Restylane in nasolabial fold ratings assessed by a blinded evaluator at each site; and 4) both products were safe and had similar adverse events related to local injection site events typical of dermal fillers. BioForm is a medical aesthetics company.
• A simple test can accurately identify which newborn babies are at risk for developing dangerous levels of jaundice, according to researchers at The Children’s Hospital of Philadelphia (Philadelphia). While neonatal jaundice, a yellowing of the skin caused by a buildup of a blood product called bilirubin, is common in newborns and usually disappears on its own, it can progress to brain damage in a small fraction of cases.
The American Academy of Pediatrics (Elk Grove Villiage, Illinois) currently recommends two options, used alone or in combination, to assess an infant’s risk of developing severe hyperbilirubinemia: a predischarge measurement of the bilirubin level and a screening checklist of risk factors such as intended method of feeding, siblings with history of jaundice, and race.
The Children’s Hospital researchers say that the predischarge bilirubin measurement, combined with the baby’s gestational age, is the most accurate method for predicting whether the newborn is at risk. About four million babies are born in the U.S. each year. Of those, an estimated 60% may develop jaundice in the first few days of life, but only about 1 in 100,000 will develop bilirubin levels that cause brain damage, known as kernicterus. The Children’s Hospital of Philadelphia was founded in 1855 as the nation’s first pediatric hospital.
• Olympus America (Center Valley, Pennsylvania) said that the FDA has cleared the Olympus PK7300 automated microplate system for use in the U.S. The FDA has also licensed blood grouping and phenotyping reagents specifically formulated and manufactured exclusively for use on the PK7300 instrument. Designed for blood donor centers, the system will offer the performance that has made Olympus the leader in the field. Olympus systems test more than 90% of the North American blood supply. The newest member of the PK7000 series utilizes the same proven technology, agglutination in the Olympus microtiter plates, as its predecessors – the Olympus PK7100 and PK7200 systems. The PK7300 system will also offer users enhanced process control features, increased throughput, upgraded computer hardware and software, and reduced maintenance. Olympus makes high-throughput automated blood bank instruments.