Arbios Systems (Waltham, Massachusetts) reported preliminary results following the enrollment of patients in the feasibility clinical trial of its SEPET liver assist device. The study has enrolled patients suffering hepatic encephalopathy ranging from Grade 2 (characterized by pronounced lethargy and loss of muscle motor control) to Grade 3 (inability to remain awake) to Grade 4 (coma). The SEPET is a sterile, disposable cartridge containing microporous hollow fibers with permeability characteristics. When a patient's blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (i.e., hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration). Arbios Systems is developing proprietary medical devices and cell-based therapies to enhance the survival of millions of patients each year who experience, or are at risk for, life-threatening episodes of liver failure. Arbios makes cell-based therapies for patients who experience life-threatening episodes of liver failure.

Draeger Medical (Telford, Pennsylvania) said it received 510(k) clearance for its Infinity TeleSmart system featuring a compact device capable of monitoring ECG and SpO. It provides a full-size patient monitor, packaged in a compact patient-worn telemetry device for adult and pediatric patients. Based on 802.11b WiFi technology, it provides continuous standalone monitoring — even if the patient moves out of the hospital's wireless network coverage area.

FoxHollow Technologies (Redwood City, California) reported launch of the SilverHawk SXL, part of its product line which includes 10 different sizes of minimally invasive catheters designed to remove atherosclerotic tissue that blocks leg arteries in patients suffering from peripheral artery disease. The SilverHawk has a lengthened nosecone that features 150 micron laser-drilled vent holes in the tip of the catheter. The tiny vent holes help to release fluid during tissue collection. When combined with the longer nosecone, this new technology may allow for increased tissue collection capacity. FoxHollow makes endovascular therapeutic devices for the treatment of peripheral artery disease.

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