August 1, 2002

Terumo releases BABY-RX oxygenator designed for neonates and infants to facilitate open heart surgery

Terumo Corporation (Head Office: Shibuya-ku, Tokyo; President: Takashi Wachi) has released the CAPIOX RX05 BABY-RX for professional use at medical institutions.

This oxygenator having the smallest priming volume in the world ^(*1), is designed exclusively for neonates & infants requiring open heart surgery. Compared to oxygenators for adults ^(*2), this product has much less priming volume to suit the needs of the small patient.

The company aims to sell 1,000 units in Japan during the first fiscal year.

*1 Per manufacturer's specifications, May 2002.
*2 Oxygenator for adult: CAPIOX RX25 has priming volume of 250mL.

"Oxygenators" are used during cardiac surgery as a substitute for the lungs, adding oxygen to circulating blood, while removing carbon dioxide. As far as open-heart surgery for pediatrics are concerned, approximately 7000 operations are performed in Japan each year.

Such small patients are suffering from congenital heart diseases such as VSD: Ventricular septal Defect - (a hole between the left ventrical and right ventrical of the heart), complication of the valve, or other diseases.

Product features of BABY-RX

1. Low Priming Volume
   The priming volume of the oxygenator is 43mL, the lowest priming volume in the industry ^(*3). For the small patients, it is crucial for only the minimal blood amount to traveling outside the small bodies.
   With a small priming volume, the need for blood transfusions and infusion therapy during surgery can be minimized.
   

   *3 Per manufacture's specifications, May 2002.

2. Superior Gas Exchange performance
   BABY-RX is capable of adding oxygen and removing carbon dioxide at a blood flow rate as high as 1.5L/min, almost doubling the performance of oxygenators available in the market ^(*4) for neonates and infants.
   

   *4 oxygenators for neonates/infants available in the market has max flow of 0.8L/min.

3. Terumo's biocompatible Xcoating
   The BABY-RX is treated with X-coating, Terumo's biocompatible , hydrophilic polymer surface coating that reduces platlet adhesion and protein denaturation.
   This is the first biocompatible coated oxygenator for neonate and infant in Japan.

Terumo oxygenators

Oxygenators function by passing oxygen through straw-like fibers (hollow fibers), where blood gases are exchanged via tiny pores in the fiber walls. Terumo was the first company in the world to market hollow-fiber oxygenators in 1982. Terumo currently holds a share of more than 28% (No. 1)^*5 of the Japanese market for oxygenators with its present lineup of CAPIOX SX and CAPIOX RX.

In July 1999, Terumo acquired the Cardiovascular Division of the U.S. company 3M, establishing the capability to offer a complete line of extracorporeal circulation products required for open-heart surgery. BABY-RX will also be released in Asia and Europe very soon. FDA 510K has been submitted, and waiting for approval to release in United States as well.

BABY-RX complements Terumo's oxygenator lineup, and is strategically a very important product for the company with its aim of further expanding its share in the global extracorporeal circulation system market.

*5 Projected by Terumo for FY2001.

Reference: Insurance Reimbursement Prices (in Japan)
CAPIOX RX05 (with reservoir): 229,000 yen
CAPIOX RX05: 216,000 yen

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