April 5, 2004
Coronary Stent System, a therapeutic cardiovascular device
Terumo releases Tsunami, a new type of stent, in Japan
Terumo Corporation (Headquarters: Shibuya-ku, Tokyo; President: Takashi
Wachi) released on April 6 the "Tsunami," a new type of coronary
stent system for use by Japanese medical institutions in the treatment of
cardiac infarction and angina. The stent is available at a suggested retail
price (the insurance redemption price of the designated insurance medical
material) of 318,000 yen per unit. The sales target is about 2.5 billion
yen in FY2004.
If
a coronary artery of the heart becomes narrowed or clogged, PTCA, i.e.,
percutaneous transluminal coronary arterioplasty, is performed to dilate
the blood vessel by means of a balloon fitted to the tip of a thin tube
called a catheter. However, after the treatment with PTCA, the dilated
blood vessel may become narrowed again. This is reported to occur in about
40% of the dilated blood vessels within 6 months of the treatment.
Coronary stent is cylindrical wire netting about 3 mm in diameter, which
is used to retain the lumen of the blood vessel that has been dilated
by a balloon. The stent enables the rate of recurring stenosis to be reduced
down to about 20%. In Japan, more than 100,000 people receive treatment
using the stent every year.
Terumo has been marketing the stent "Tsunami" since 2001 in
Europe and Asia. The company has conducted after-the-sale clinical tests
(under the program name of TESTER) with 100 patients participating in
a program jointly conducted at various medical institutions of several
countries in these regions. As a result, it was reported that the rate
of recurring stenosis was 13.8% within 6 months of the treatment.
Features of Coronary Stent "Tsunami"
Flexibility and strong retention
The stent with a thickness of 80µm is designed in a Duo-Link structure,
in which 6 diamond shapes are connected serially to form a ring, with
two bridges linking between neighboring rings. The stent reduces the stress
on the blood vessel, and is free to fit flexibly in the affected area
of any winding blood vessel. It is expected that the stent will keep the
lumen of the blood vessel dilated with its strong retention force.
Bridges linking diamond-shaped rings (after the stent
has been expanded) |
Easy to pass through bent or crooked blood vessels
The compact stent is fitted to the balloon so that it can be passed through
the lumina of blood vessels and inserted smoothly into the targeted site.
Before the stent is expanded, it is expected that the stent can be smoothly
passed through the narrowed blood vessels.
(Brand name: Tsunami; Medical device authorization No. 21600BZZ00140)
Terumo has been exploiting high ease-of-use of catheters, and has developed
new types, such as Ryujin and Seiryu, the expansion catheters for PTCA,
which have already been released for use in the cardiovascular field.
Furthermore, in the stent field, too, the company has been proceeding
with the development of medical devices that contribute to the health
and welfare of many patients.