• Angiotech Pharmaceuticals (Vancouver) said that the FDA has given it clearance to begin marketing the Hemo-Stream chronic dialysis catheter. The catheter, developed by Rex Medical (Conshohocken, Pennsylvania), is a chronic hemodialysis catheter specifically designed for over-the-wire delivery. Dialysis catheters, such as Hemo-Stream, are used for short-term vascular access to provide hemodialysis patients with the dialysis they require. Rex Medical makes minimally invasive medical devices targeted towards the cardiovascular, venous access, endosurgery and oncology markets. Angiotech Pharmaceuticals is a specialty pharmaceutical and medical device company.

• Edwards Lifesciences (Irvine, California) reported the introduction of its Edwards PediaSat Oximetry Catheter, a real-time, continuous ScvO2 monitoring device designed specifically for children. This central venous catheter uses fiber optics to monitor and identify potentially life-threatening changes in oxygen-saturation of venous blood in critically ill children. Until now, clinicians have had to rely on manual, intermittent blood sampling to monitor a child’s oxygenation status in a critical care setting. Intermittent blood sampling incurs the risks of multiple blood draws, infection and increased potential for transfusions, the company said.

• FlowMedica (Fremont, California) said that it has met its objective of enrolling 500 patients in the Be-RITE registry. This is the first targeted renal therapy registry data set that contains a significant number of patients with renal insufficiency who are at high risk for contrast induced nephropathy (CIN), the company said. The Be-RITE registry is an observational, retrospective registry that is designed to capture “real world” usage patterns, device performance characteristics, clinical outcomes and adverse events data associated with either the Benephit CV or Benephit PV infusion system. The Benephit systems have not yet received clearance to treat or prevent CIN or any other condition. FlowMedica specializes in targeted renal therapy.

• I-Flow (Lake Forest, California) said that results of its ON-Q prospective human study in colorectal surgery will be presented Sept. 18th at the Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC) in Chicago. The study was designed to explore the potential of ON-Q to reduce surgical site infections and to therefore expand ON-Q’s clinical benefits beyond pain relief into the area of surgical site care. ON-Q is now labeled to reduce pain better than narcotics and to significantly reduce narcotics intake after surgery. It consists of a small balloon pump that holds a local anesthetic and delivers it automatically through a specially designed catheter to provide even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities.

• Inion (Helsinki, Finland) said the FDA has granted it clearance to market a biodegradable screw in the U.S. for use in surgery on several parts of the body in addition to the knee, for which it was originally designed. Inion said the FDA’s decision means its Inion Hexalon screw can now also be marketed for use in surgery on the shoulder, elbow, ankle, foot, hand and wrist. The screw fixes soft tissue to bone, is colored to make surgery easier and degrades completely over two years. It was originally developed to help in repairing cruciate ligament damage.

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