RE: Radioactive Seeds

[Craig Reed <CReed@novoste.com>]

Emil,

To your question about an informercial: Intravascular Brachytherapy is
not yet approved by the FDA for commericial use in the United States.
Although Novoste Corporation has approval for the therapy OUTSIDE the US
and Investigational Device Exemption(s) to conduct clinical trials
inside  the US, we are awaiting clinical data from our trials in order
to complete the FDA Pre-Market Approval Process.

So, to your point, an info-mercial for the general US public promoting
safety and efficacy of a technology would not be consistent with 21 CFR
812.7.

Craig Reed
Radiation Regulatory Manager
Novoste Corporation
creed@novoste.com

-----Original Message-----
From: Kerembaev@cs.com [mailto:Kerembaev@cs.com]
Sent: Saturday, February 05, 2000 10:25 PM
To: Multiple recipients of list
Subject: Re: Radioactive Seeds


Radsafers,

Why do not put it among with other medical applications in a TV
infomercial 
to help the cause?
I have seen the TV infomercial about "a product calls plastic", which
saves 
lives (Chemical Industry???).
Well, some of us do remember Union Carbide's Bhopal 1985-?.(5,000
instant 
deaths)

Emil.
kerembaev@cs.com


In a message dated 2/5/00 12:19:11 Pacific Standard Time,
NFRGTBLIS@aol.com 
writes:

>>>

Melissa J. Engelhard
nfrgtblis@aol.com

Radioactive Seeds May Keep Arteries Open  
February 1, 2000 

NEW YORK (Reuters Health) â?" Temporarily placing tiny radioactive
pellets in 
a 
heart artery that has just been unclogged during an angioplasty
procedure can 
safely prevent reblockage of the vessel over the next 3 years, the
results of 
a new study show.

During angioplasty, a balloon-tipped catheter is threaded into a blocked

artery and inflated, flattening fatty plaques against the artery wall
and 
allowing blood to flow more freely through the vessel. Since the artery
often 
becomes clogged again, surgeons sometimes implant a metal coil called a
stent 
to keep the artery open. But reblockage may still occur when scar tissue

builds up on the stent.

A technique that involves temporarily threading a ribbon containing 
radioactive pellets into an artery has been successful in keeping
arteries 
open in the months after angioplasty, but the long-term effectiveness
and 
safety of the procedure has been unknown.

In the current study, a team of researchers led by Dr. Paul S.
Teirstein, of 
the Scripps Clinic in La Jolla, California, followed 55 people who had a

heart artery reclog after angioplasty. Some of the participants already
had 
stents, while some received the stents during the study. Twenty-six
people 
were picked at random to undergo the radiation treatment.

Three years later, the radiation group fared significantly better than
the 
group that did not receive the experimental treatment, Teirstein's team 
reports in the February 1st issue of Circulation: Journal of the
American 
Heart Association. Arteries had reclogged in only about 15% of patients
who 
underwent radiation, compared with about 48% of those who had not. Also,
the 
combined rate of heart attacks, deaths and reblockages was around 23% in

those who underwent radiation, compared with about 55% of those who did
not.

The researchers did not detect any harmful side effects caused by the 
radiation.

In an editorial that accompanies the study, Drs. David O. Williams and
Barry 
L. Sharaf, of Brown University School of Medicine in Providence, Rhode 
Island, point out that several questions remain about using radiation to
keep 
arteries from becoming blocked again.

For example, Williams and Sharaf note that it is important to determine
if 
the effect of radiation varies depending on whether or not a person has 
already received a stent. In addition, they suggest that longer
follow-up is 
needed since it may take 5 to 15 years to detect some effects of
radiation.

SOURCE: Circulation: Journal of the American Heart Association 
2000;101:350-351, 360-365.


Copyright 2000 Reuters Limited. All rights reserved. Republication or 
redistribution of Reuters content, including by framing or similar
means, is 
expressly prohibited without the prior written consent of Reuters.
Reuters 
shall not be liable for any errors or delays in the content, or for any 
actions taken in reliance thereon. 
 
 >>>


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