News: October 08, 2007

FDA Approves REALIZE(tm) Adjustable Gastric Band For Morbid Obesity.
Johnson & Johnson/Ethicon Endo-Surgery recently gained PMA approval for
its REALIZE(tm) adjustable gastric band for morbidly obese adults. A
full market launch of the product is expected in early 2008.
REALIZE(tm) is for patients with a body mass index of at least 40 kg/m2,
or 35 kg/m2 with one or more co-morbidities. REALIZE(tm) consists of a
soft adjustable silicone band that wraps around the stomach to create
two chambers-the upper chamber only holds four ounces of food at a time.
In the clinical trial for the device, patients reported improvements in
various aspects of their quality of life and better general health one
year after surgery. Additional information is available at
www.thegraysheet.com (paid subscription
service) or http://www.medicalnewstoday.com/articles/84044.php

Gene-Chip Technology Finds New Leads In Treating Lung Disease Of
Premature Newborns. Twenty to 40 percent of extremely premature infants
suffer abnormal lung development leading to bronchopulmonary dysplasia
(BPD), a chronic lung disease that can cause long-term breathing
problems. Researchers from Children's Hospital Informatics Program
(CHIP), based at Children's Hospital Boston, have used gene-chip
technology to examine the umbilical cords of premature infants. They
discovered that extremely premature infants who go on to develop BPD
exhibit a disruption in the chromatin remodeling pathway. This
biochemical pathway is responsible for unwrapping coiled strands of DNA,
which must occur before a gene can act or be expressed. If researchers
are able to prevent that pathway from being switched on, BPD may be
preventable, potentially improving the rocky clinical course of
premature newborns. Although in its early stages, the study validates
the hypothesis that the umbilical cord makes a good proxy for studying
fetal lung physiology. Unlike lung tissue, umbilical cord tissue is
readily available to researchers, contains stem cells for many fetal
tissues, and appears to reflect the physiology of the fetus and the
intrauterine environment. Additional information is available at
http://www.medicalnewstoday.com/articles/84587.php.

CMS Unlikely to Use More External Data to Set Medicare Payments. CMS is
unlikely to expand its use of external data in setting Medicare payment
rates following a recent report from the Government Accountability
Office. The September 26, 2007, report acknowledges the limitations of
using external data, but generally reinforces CMS's approach. The
report concludes that CMS may occasionally use external data in
conjunction with internal data to determine new technology add-on
payments and to reclassify procedures into different inpatient payment
groups. However, the report does not delve into CMS policies for
accepting external data nor does it suggest other uses of such
information. Additional information is available at
www.thegraysheet.com (paid subscription
service).