Datascope Corp announced the worldwide launch of the CS100 automatic intra-aortic balloon pump, recently cleared for marketing in the U.S. by receipt of FDA 510(k) approval and in Europe by receipt of the CE mark.

The CS100 balloon pump is the first fully automatic pump produced by Datascope, the most advanced pump of its kind, and sets a higher standard of care for patients who require IAB support. Operation of the new pump is extraordinarily simple. Its one-button startup provides faster initiation of therapy, which is particularly valuable in cardiac emergencies.

Importantly, because the CS100 is fully automated, it frees up healthcare staff from unnecessary pump management, allowing them more time for patient care. Also, using a new, proprietary software program, called IntelliSync, the CS100 gives patients more consistent therapy with greater continuity.

The CS100 is the second major product launch in the past 18 months for Datascope's Cardiac Assist Division. In 2002, the division launched the Fidelity 8 Fr. balloon catheter, featuring a unique co-lumen design that provides higher fidelity blood pressure waveforms, and faster inflation/deflation times. The Fidelity 8 Fr. is a premium priced catheter that currently generates more than 60% of the company's balloon catheter sales.

Balloon pump therapy, or counterpulsation, is widely used to provide temporary assistance to the heart in a variety of critical care settings, including cardiogenic shock, high-risk coronary angioplasty/stenting procedures, and coronary bypass surgery. Counterpulsation refers to inflation and deflation of an intra-aortic balloon synchronized with the heartbeat in a manner that provides a two-fold assist to the beating heart: increasing its oxygen supply while decreasing its oxygen demand, an intervention that often restores the supply and demand balance necessary for the patient's recovery.

With its introduction, the CS100 becomes the premier balloon pump offered by Datascope. The company believes that reliable automatic balloon pump technology, as embodied in the CS100, is the wave of the future. Accordingly, the company expects the simplicity of using the automatic CS100 to be favorably received in the market, especially so in the growing community hospital segment. Over time, the CS100 is expected to account for an increasing percentage of Datascope's balloon pump sales. In the fiscal year ended June 30, 2003, sales of the Cardiac Assist Division which manufactures and markets Datascope balloon pumps were $118.4 million, 36% of total corporate sales.