AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology designed to reduce the accumulation of catheter-related thrombus on, and in, the catheter. These are the first vascular access products from AngioDynamics to offer BioFlo technology in the U.S. market and an initial launch is expected in the Company’s second quarter of fiscal year 2013. These products are currently CE marked for Europe and are approved in Canada and other international markets.

体外血换模型试验结果表明,与基于血小板计数的常用PICCs相比,Bioflo PICC在其表面上具有87%的血栓积聚。In addition, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.* Available with PASV Valve Technology, it is the first catheter that combines all of these properties with AngioDynamics’ patented valve designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.

“Bioflo Technology提供了一个真正颠覆性技术的血管动力学,我们认为将推动对血管接入产品的需求增加,”血管动力学总裁Joseph Devivo说。“占3.75亿美元美国PICC市场的15%,血管动力学持有强劲的第二个职位,Bioflo技术被定位,以帮助我们成长。Bioflo Technology表示希望减少导管相关血栓的积累而不掺入肝素,抗生素,抗微生物或任何与涂覆或浸渍技术相关的任何其他瞬态材料。“

PICC允许静脉内接入延长的化疗,抗生素递送和其他血管内疗法。Bioflo PICC是唯一用Endexo技术制造的PICC,永久和非洗脱的整体聚合物。Endexo被混合到导管轴的聚合物中,从而产生提供长期耐久性的材料。在整个导管轴材料中存在,并且不是浅表或瞬态的涂层或浸渍材料。Bioflo PICC不含有抗生素或抗微生物,可能与细菌抗性有关的药剂。

“我们预计在未来30天内将在美国帕斯沃Piccs推出Bioflo Technology,”全球血管通路特许经营权副总裁Chuck Greiner说。“鉴于我们在加拿大第一次市场发布期间看到的早期成功,我们很高兴能够复制美国市场的快速采用。此外,我们计划通过寻求一系列生物活端口和生物活性透析导管的FDA清关进一步发展我们的投资组合。“

*体外预临床和体内评估不一定​​预测相对于血栓形成的临床表现。

来源:AngioDynamics