October 2000

New Terumo TEMPEST(tm) PTCA dilatation catheter

On September 29, Tokyo-based Terumo Corporation released the new TEMPEST(tm) PTCA dilatation catheter in Japan. The TEMPEST is used in PTCA (Percutaneous Transluminal Coronary Angioplasty) procedures for treating ischemic heart diseases such as angina pectoris and myocardial infarction caused by narrowed or occluded coronary arteries.

For the period ending March 2001, Terumo has set a sales objective of 600 million yen for the new TEMPEST PTCA catheter.

The TEMPEST is a modified version of the Terumo GALE(tm) PTCA dilatation catheter, introduced to favorable market reception in December 1998. The internal tubing and the distal tip of the TEMPEST has been changed. The modifications ensure more precise guide wire control and better crossability to stenotic lesions, and offer easy guide wire exchange.

The TEMPEST is an over-the-wire type catheter in which the guide wire passes through from the proximal end to the distal tip. The balloon of the catheter is a semi-compliant type (the balloon moderately inflates in response to pressure), and can be used for a variety of operations.

PTCA is a therapy for ischemic heart diseases that dilates narrowed or occluded coronary arteries with a balloon attached to the distal part of a PTCA dilatation catheter tube (approximately 1mm diameter). Because PTCA is a transvascular therapy, it is far less invasive compared with bypass surgery. Only a few days are required in hospital, significantly reducing the economic burden. This method of treatment is also in accordance with government policy to reduce medical costs. Approximately 120,000 PTCA procedures are currently carried out in Japan each year.

TEMPEST features

1. Superior guide wire maneuverability
   A new material employed in the catheter's inner shaft assures smoother guide wire maneuverability.
2. M-Coat(tm) Hydrophilic coating
   The distal shaft (approx. 18cm) is coated with a hydrophilic polymer, providing superior lubrication when moistened. This ensures exceptional trackability and smoother crossability.
3. Flexible, low-profile tip
   The catheter features a very low entry-profile of 0.018 inch. This low profile, coupled with a flexible long tip, assures better crossability.
4. Double markers
   Double radiopaque markers are employed (except on 1.5mm balloon models) to achieve precise balloon positioning.

Terumo has contributed to the progress of transcatheter intervention through the development of related products such as PTCA dilatation catheters, coronary stents, and IVUS (Intravascular Ultrasound) systems. Terumo is committed to the continued development of high quality medical equipment that contributes to minimization of patient stress and reduction of medical costs.

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