New Needleless Connector Visibly Reduces Blood Backflow during Luer Connection and Disconnection to Help Maintain Catheter Patency and Reduce Occlusions

Waukegan, IL – January 15, 2003 -- A new Needleless Connector being introduced on January 31, 2003 by IntraVascular Incorporated™ located in Waukegan, Illinois, visibly reduces blood backflow during luer connection and disconnection according to an independent study. This new device, named the FloStar™, is being introduced just in time to present healthcare facilities the opportunity to further reduce needlestick occurrences and blood contamination. This is a key point in healthcare facility operations in light of the updated reporting guidance document – Medical Device Reporting (MDR) regulation 21 CFR Part 803 - issued by the FDA in November, 2002 for user facilities, manufacturers, and importers of needlestick devices1.

The FloStar™'s needle-free connection accepts luer slips or luer locks, is Latex and DEHP free, and has a high pressure back-check valve that eliminates the fear of contaminating the care giver. With its patented valve system, the FloStar helps to reduce occlusions caused by retrograde blood flow and to maintain catheter patency. It also has a highly effective decontamination zone, with its raised profile luer access. Compared to the positive and negative pressure valves on the market today, the FloStar is setting a new standard in needleless vascular access and protection.

The FloStar product was acquired by IntraVascular Incorporated in 2002 from an international health care company. According to Steven Aperavich, President of IntraVascular Incorporated, the FloStar has been a long time in coming to market. "IntraVascular has been able to move beyond positive pressure needleless connectors with the FloStar by reducing reflux", says Mr. Aperavich. "While positive pressure connectors may stop backflow during luer disconnection, they do cause backflow during luer connection, which essentially trades one problem for another. The FloStar visibly reduces the reflux for both connection and disconnection with its patented dual valve system."

IntraVascular Incorporated™ is currently developing a complementary line of infusion therapy products with the FloStar™ technology. These developments will continue to set a new standard in the needleless vascular access market. Meanwhile, the FloStar is the one choice for healthcare facilities that are focused on reducing their needlestick occurrences and blood exposures while benefiting their patients by reducing catheter occlusions.

IntraVascular Incorporated is a privately held corporation of David H. Sanders who has been a very successful entrepreneur in the health care field for the last three decades. Among his successes are BCI International® and Surgitek®. He is also currently the Chairman and owner of Medikmark Incorporated, which markets sterile procedural kits and trays for hospitals, nursing homes, and home healthcare providers.

1 Copies of this information can be obtained from the FDA's website at www.fda.gov/cdrh/osb/guidance/250.html.

Source: IntraVascular Incorporated