Medtronic gets OK to sell stent in Europe
July 31, 2005

Medtronic will immediately roll out in Europe, the Middle East and Asia its Endeavor
drug-eluting stent, a tiny, wire mesh tube coated with medicine to keep arteries open
during angioplasty procedures.

Medtronic Inc. said it received approval from European health regulators to sell the
stent. The medicine which is licensed from Abbott Laboratories Inc. to keeps the
treated coronary arteries from reclogging.

Drug-coated stents may help diabetes, research finds                                          
March 2005
Boston Scientific Corp.'s Taxus stent, a tiny mesh tube keeping heart artery open,
have been shown benefitsl to some patients suffered from diabetes. This helps them
to avoid a more drastic alternative-heart bypass surgery. Currently, Johnson &
Johnson's Cypher drug-eluting stents are shown no major significant statistical
difference between the two in effectiveness. The trial showed that both stents were
equally easy to deliver into the body and there was no major difference in restenosis.
However, J&J said in its press release that stent thrombosis, or blood clotting, was
78% lower with the Cypher stent than with the Taxus .

Kastrati et al reviewed six studies on stent treatment. They found less artery-opening
surgery need later with sirolimus-coated stents than with paclitaxel-coated stents.
However, they also observed that similar rates of death, heart attack and clotting at
the stent with both drugs. 4
4. Kastrati, A. The Journal of the American Medical Association Aug 17 2005 294
Stent is a tiny wire mesh structure to keep arteries open. During operation,
surgeon insert this scaffolding to prop open arteries that have been
narrowed or even clogged with fatty plaque. The first stents were made of
bare metal, but they could be squeezed shut easily. Nowaday, stents are
coated with drugs. Drug-coated stents release drug or medication slowly into
blood vessels to keep them from squeezing shut after surgery to remove
blockages. In most cases, they are effective even tiny vessels with very big
blockages and the effect last for years.

One of those drugs used in stents is sirolimus. Its function is to soothes
inflammation. The approved sirolimus for use in drug-coated stent (Johnson
and Johnson, Cypher Sirolimus-eluting Coronary Stent) in 2003. This is the
first U.S. approved combination drug device intended to help reduce
restenosis (reblockage) of a treated coronary artery. Sirolimus soothes
inflammation. Restenosis could be considered as one of the greatest
challenges in long-term patient treatment in interventional cardiology at that
time. The treating process is controlled by a polymer coating that gradually
release the drug sirolimus into the vessel lining to prevent scar tissue
growth. Scar tissue growth is a frequent reaction that leads to reblockage of
the artery.

Another drug-coated stent uses paclitaxel (TAXUS Express Paclitaxel Eluting
Coronary Stent System, Boston Scientific). Paclitaxel is an anti-cancer drug.
In this system, it selectively inhibits smooth muscle cell proliferation to
faciliate the natural healing process. Same as Cypher, the TAXUS Express
Paclitaxel-Eluting Coronary Stent System has the power to reduce
restenosis, treat a variety of lesions and achieve safe, predictable, outcomes
for patients. TAXUS Express Stent has demonstrated consistent and low
rates of revascularization and restenosis reduction. [1,2] TAXUS Express
Stent has a low rate of sub-acute thrombosis and stent thrombosis through
12 months. [1] Major adverse cardiac event rate is 8.5% at 9 months and
10.6% at 12 months [1].

Research has shown advantages of the drug-coated stents. Drug-coated
stents work much better than bare-metal stents in preventing major heart
diseases. [3]

1. TAXUS IV Clinical Trial Data. Sep 2003
2. TAXUS I, II & IV Clinical Trials
3. Kastrati, A. The Journal of the American Medical Association Aug 17 2005
294 819-925.