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For Immediate Release

Makrolon® Polycarbonate from Bayer MaterialScience LLC Helps Orqis Medical Redefine Heart Failure Therapy

February 12, 2007

PITTSBURGH, February 12, 2007 — For patients suffering from congestive heart failure, Orqis Medical Corporation's Cancion® System offers an investigational method to supplement the heart in its job of pumping blood to the body. Makrolon® 2558 polycarbonate resin from Bayer MaterialScience LLC (BMS) is used for molding multiple components of the Cancion System, which serves to minimize damage to fragile blood cells and reduce clotting as the device augments blood flow through the patient's descending aorta.

The Cancion System, currently being evaluated in the pivotal MOMENTUM clinical trial, provides continuous aortic flow augmentation using an innovative new centrifugal pump and proprietary catheters to create a supplemental circuit that takes pressure off the heart. The company calls this a "rest to recovery" treatment for acutely decompensated congestive heart failure patients who do not respond adequately to standard medical therapy. By alleviating the heart from some of its work, Orqis hopes to show that the heart can grow stronger, allowing patients to feel better, leave the hospital and remain out of the hospital.

When the Cancion System is used, catheters are inserted into the patient's femoral arteries, drawing blood out through the left artery and into the pump, which propels it back into the body via a longer catheter. The longer catheter enters the right artery and extends up through the descending artery where it terminates with a U-turn near the aorta, discharging blood back into the normal flow.

Makrolon polycarbonate was selected by Lake Forest, Calif.-based Orqis Medical for the critical catheter connectors because of its biocompatibility, robustness and clarity. These same attributes led Levitronix® LLC of Waltham, Mass., to choose Makrolon polycarbonate for its CentriMag® Blood Pump, a key component of the Orqis system.

Makrolon 2558 polycarbonate is an easy-flow polycarbonate resin with outstanding impact strength and ductility, excellent electrical properties and dimensional stability. Certain color formations have met the requirements of the FDA-modified ISO 10993, Part 1 "Biological Evaluation of Medical Devices" tests. Biocompatibility and durability of Makrolon polycarbonate are critical to the applications.

"Most catheters are intended for short-duration, single-use injections," said Robert Pecor, senior R&D engineer for Orqis, explaining why Makrolon polycarbonate was selected for the connectors. "Unlike the Cancion System, very few are designed for long-term use with blood continuously flowing through them."

"We have to be very careful to minimize the potential for thrombosis, or damage to the blood cells," Pecor said. With that in mind, the Makrolon polycarbonate connectors were designed to create smooth joints between the urethane catheters and PVC tubing used in the system.

Pecor credits Bayer's engineering support with helping to refine the injection molding process, assuring proper flow and establishing better processing parameters for the connectors, which are molded by Advanced Technology of Corona, Calif. "We're very pleased with the material. It's clear and robust, and we get a consistently high quality product that works exactly as intended," said Pecor.

At the heart of the system is the CentriMag centrifugal pump, which uses magnetic levitation to create the fluid dynamics necessary for circulatory support applications. The pump is assembled from four Makrolon polycarbonate parts and a magnet. The magnet is encased in two white polycarbonate components, creating the pump's impeller. The impeller floats inside a clear polycarbonate housing, made of two parts bonded together to form a chamber with a top inlet orifice and a side discharge outlet.

This pump is placed inside a unique motor receptacle with no moving parts. The motor uses electromagnetic forces to levitate and rotate the impeller within the pump chamber.

The CentriMag blood pump is capable of generating blood flow rates as high as 9.9 liters per minute with a lower limit of flow of 400 milliliters per minute required by neonatal cases. Use of magnetic levitation eliminates shafts, seals, bearings and heat-generating friction, thus minimizing the risk of hemolysis and thrombus deposition. The efficient design of the pump accommodates low flow rates required by the Cancion System without blood stasis occurring.

"It's gentle on blood," summed Kurt Dasse, Ph. D, chief executive officer of Levitronix.

The CentriMag pumps are injection molded and robotically assembled in a clean-room environment, and the chambers are bonded with a UV-curable adhesive. "We picked this material because it is known for being biocompatible. We put it through many batteries of tests to demonstrate that it didn't cause thrombosis and could be used for the intended duration," said Dasse. The Makrolon polycarbonate is "fantastic" because of its clarity and biocompatibility, according to Dasse, who added that Bayer's technical support group was very instrumental in helping Levitronix bring the pump to fruition.

"It speaks to Makrolon's strengths for medical uses that it was chosen separately by two discerning customers for use in this pioneering therapeutic tool," said explained Kevin Dunay, BMS LLC NAFTA Market Segment Leader for Medical. "The Cancion System becomes another in a steady progression of life-saving devices in which Makrolon polycarbonate has played a positive role."

For more information on the Cancion System from Orqis Medical Corporation, call 1-949-707-5890 or visit www.orqis.com.

For more information on the Levitronix CentriMag Blood Pump from Levitronix LLC, call 1-781-622-1224 or visit www.levitronix.com.

For more information injection molding from Advanced Technology, call 1-951-279-4810, ext. 204, or visit www.10dayparts.com.

For more information about Bayer MaterialScience's Makrolon polycarbonate resin, call 1-800-662-2927 or visit www.bayermaterialscienceNAFTA.com.

Bayer MaterialScience LLC is one of the leading producers of polymers and high-performance plastics in North America and is part of the global Bayer MaterialScience business with nearly 19,000 employees at 40 sites around the world and 2005 sales of 10.7 billion euros. Our innovative developments in coating, adhesive and sealant raw materials, polycarbonates, polyurethanes and thermoplastic urethane elastomers enhance the design and functionality of products in a wide variety of markets, including the automotive, construction, electrical and electronics, household and medical industries, and the sports and leisure fields. Our inorganic basic chemicals unit produces chlorine and related essential products for the chemicals industry. Let us give life to your vision. Bayer MaterialScience — Where VisionWorks.

Bayer Corporation, headquartered in Pittsburgh, is a subsidiary of Bayer AG, an international health care, nutrition and innovative materials group based in Leverkusen, Germany. In North America, Bayer had 2005 net sales of 7.3 billion euros and employed 16,200 at year end. Bayer's three operating companies — Bayer HealthCare LLC, Bayer CropScience LP and Bayer MaterialScience LLC — improve people's lives through a broad range of essential products that help diagnose, prevent and treat diseases, protect crops and advance automobile safety and durability.

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Media Contact(s)
Name:	Scott Hunsberger
Phone:	412-777-5200
Company:	Bayer MaterialScience
Email:	scott.hunsberger@bayerbms.com

The Orqis Cancion System uses Makrolon 2558 polycarbonate resin in key components. The Orqis system, now in clinical trial, is being investigated as a therapy for patients suffering from congestive heart failure.