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Nonsurgical Treatment for Benign Breast Tumors wins FDA Approval
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The FDA approved a treatment for benign breast tumors that
uses a needle to freeze and destroy fibroadenomas, Reuters reports.
Endocare's cryoablation technology [in which extremely cold
temperatures guided by ultrasound destroy tissue or tumor cells]
is already on the market as a treatment for prostate cancer,
enlarged prostate, and cardiac arrhythmias. According to Endocare
CEO Paul Mikus, the technology may help as many as 500,000 women
diagnosed annually with benign breast tumors avoid surgery.
He describes Endocare's technique as a "20-minute, office-based
approach." The procedure reduces recovery time and complications,
compared with surgery, and most patients can return to normal
activities the day after treatment, Endocare asserts (Reuters/Washington
Post, 10/17).
"The procedure leaves no apparent scar at three months
of the initial 3mm skin nick that fades," says Karmanos
Cancer Institute radiologist Peter Littrup, M.D. "It is
virtually painless and has palpable improvement of the mass
effect by six months.
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"The 'painless' aspect
led us to do the percutaneous cryosurgery of other sites
including the liver, kidney, lung, and bone with no anesthesia.
This is markedly different than radiofrequency (RF) ablation
which requires full anesthesia but is commonly done around
the country," says Littrup.
"It is also the proof-of-principle step to trying
cryo-immunotherapy (cryotherapy plus immune stimulating
drugs) under a soon to be launched protocol."
The Institute contributed more patients than all other
U.S. centers combined for the clinical research study
that led to the FDA's approval. |
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