Bio2 touts pivotal data on Angel catheter-filter combo

This study of a combined IVC filter/central venous catheter was the culmination of a panel of dedicated investigators with careful guidance by the FDA,” primary investigator Dr. Victor Tapson said in prepared remarks. “The efficacy and safety of the device, simple bedside placement, and the need to remove it before discharge make it very appealing. Nearly the entire cohort had crucial, yet short-term filter needs so that discharge without a filter was preferred.” The device is the 1st to be cleared by the FDA for PE prophylaxis in critically ill patients contraindicated to anticoagulation. “The publication of the results of the Angel Catheter pivotal study represents an opportunity to create awareness and further the goal of making this unique, lifesaving product available to the American public,” CEO Christopher Banas added. “Working collaboratively with the FDA as an initial participant in the FDA’s new Early Feasibility Study Program enabled Bio2 Medical to develop a clinical protocol which contributed to the pivotal study being completed 9 months ahead of schedule due to its fast enrollment.  Congratulations to the primary investigators, whose support was a major factor in the study’s success.” The post Bio2 touts pivotal data on Angel catheter-filter combo appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Catheters Clinical Trials Vascular BiO2 Medical Source Type: news