Straub Medical has announced that the first patient has been enrolled in the P-MAX study at the Karolinen-Hospital Arnsberg, Germany.
The post-market clinical follow-up study to assess the safety and effectiveness of the AspirexS venous catheter in the treatment of deep vein thrombosis will enrol over 80 patients by the time of completion. Michael Lichtenberg, the investigator who enrolled the first patient, reported that the 37-year-old woman presented with acute deep vein thrombosis and was successfully treated with AspirexS on 29 June and was discharged the following morning.
The AspirexS endovascular system is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial by – passes) outside the cardiopulmonary, coronary and cerebral circulations.
Capturex, a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolising procedures on the patient. Both AspirexS and CaptureX are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed in a real-world setting.