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Alternative for POP
Adamed, Inc's, intra-vaginal device for the medical management
of pelvic organ prolapse (POP) and weak pelvic floor muscles (Colpexin
Sphere) is now available in the United States. The product, which
has been shown to reduce POP when placed above the levator ani
muscle, may provide an alternative to surgery and traditional therapies,
such as vaginal pessaries. It may also help strengthen pelvic floor
muscles when used in conjunction with the regular performance of
pelvic floor exercises. Fully equipped with a fitting and sizing
tool kit, the product is available in five different sizes, ranging
in diameter from 32 mm to 44 mm.
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Three-Year
Contraceptive Implant
The US Food and Drug Administration (FDA) announced the approval
of Organon's newest contraceptive option, the etonogestrel
68 mg single-rod implant (Implanon). The contraceptive implant
is made of a soft medical polymer about the size of a matchstick,
and is implanted under the skin of the upper arm by a health care
provider during an in-office procedure. The implant releases a
steady dose of the progestin etonogestrel and is effective for
up to 3 years. Organon is sponsoring clinical training programs,
scheduled to begin later this year, to instruct health care providers
in proper insertion and removal of the device. The implant will
only be available to those trained through the Organon-sponsored
training programs.
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Streamlining
Risk Management
E & C Medical Intelligence, Inc, announced an agreement with Lancaster
General Hospital, Pa, to implement its proprietary risk reduction and clinical
quality improvement system for obstetrics and gynecology (Intelligent Patient
Record for Obstetrics [Iprob]). The device, a real-time risk management tool,
shows statistical reductions in risk and prevention of clinical errors in
the OB/GYN setting. The system analyzes current patient data in real-time
against an extensive clinical database of 6,500 best practice protocols and
13,000 clinical data fields, facilitating a higher level of care, minimizing
clinical error, and providing systematic documentation.
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Once-a-Day Antiretroviral
The FDA approved Bristol-Myers
Squibb Company's new oral combination efavirenz 600 mg/emtricitabine
200 mg/tenofovir disoproxil fumarate 300 mg (Atripla) for the treatment
of human immunodeficiency virus (HIV). The drug is the first ever once-a-day
single-tablet regimen to treat HIV in adults that can be used alone
or in
combination with other antiretrovirals.
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Ovarian Cancer
Adjuvant Therapy
The FDA granted expanded approval to Eli Lilly and Company's gemcitabine
(Gemzar) for use in combination with carboplatin, in women with advanced
ovarian cancer that has relapsed at least 6 months after initial therapy.
Already
approved for metastatic pancreatic and breast cancers, and non–small-cell
lung cancer, the gemcitabine adjuvant therapy showed a median progression-free
survival increase of 48% compared to patients receiving carboplatin
alone in phase 3 study results.
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Protecting Precious Heads
A new device is available from Biotech Research to help prevent plagiocephaly
and brachycephaly in infants. The cushioned head support (Baby Halo), made
from a proprietary FDA-approved mater-ial, gently supports an infant’s
head to prevent flattening, which affects up to one in 10 infants in the
United States. Originally designed for premature infants and used recently
in hospitals, the device has been redesigned to fit full-term infants. Biotech
Research plans to conduct a hospital campaign to make the device widely
available, as well as make the device available for in-home use.
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