Positive results for the ClearWay RX Infusion Catheter (Atrium) for PCI

Results of the INFUSE-AMI study demonstrated that in patients with large anterior STEMI presenting early after symptom onset and undergoing Percutaneous Coronary Intervention (PCI), intracoronary administration of the platelet inhibitor abciximab delivered directly to the Heart Attack lesion site via Atrium's ClearWay RX Local Therapeutic Infusion Catheter significantly reduced the size of the MI at 30 days (primary endpoint). The trial, conducted at 37 clinical sites in the US and five European countries, enrolled 452 patients who presented within four hours of a STEMI involving the anterior wall of the heart. Study subjects were randomized to one of four study arms, which assessed four different ways to treat the thrombus (blood clot) causing the patient's Heart Attack. The goal was to help identify which treatment strategy could provide better patient outcomes. Results showed that patients randomized to local therapeutic infusion of intracoronary abciximab with ClearWay RX compared to no abciximab had a significant reduction in 30-day infarct size (15.6 percent relative reduction). Patients randomized to local infusion of intracoronary abciximab also demonstrated a significant reduction in absolute infarct mass (22.1 percent relative reduction). Data were presented at the American College of Cardiology's 61st Annual Scientific Session in Chicago and published online in the Journal of the American Medical Association (JAMA).