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Map of Contents United States International


Pivotal Study - Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients

The pivotal study presents data from a single arm study in which 163 patients underwent Pulmonary Embolism prophylaxis via the Angel Catheter. 151 of the patients were critically ill, with 129 suffering a head or spine trauma. All of the devices were inserted and retrieved without complication. No patients suffered a clinical or fatal PE through the duration of the study. Click the link to be directed to the Journal of Vascular and Interventional Radiology for the full article.

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Pilot Study Evaluating the Safety of a Combined Central Venous Catheter and Inferior Vena Cava Filter in Critically Ill Patients at High Risk of Pulmonary Embolism

The objectives of this pilot trial were to assess the safety of a new device for pulmonary embolism (PE) prophylaxis. The device, the Angel Catheter, was placed in eight patients who were in the intensive care unit and were at high risk of PE. The device was inserted at the bedside without fluoroscopic guidance via a femoral venous approach. All eight devices were inserted and subsequently retrieved without complications (follow-up, 33–36 d). One filter trapped a large clot.

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Systematic Review of the Use of Retrievable Inferior Vena Cava Filters

Purpose: To review the available literature on retrievable inferior vena cava (IVC) filters to examine the effectiveness and risks of these devices.

Materials and Methods: Investigators searched MEDLINE for clinical trials evaluating retrievable filters and reviewed the complications reported to the Manufacturer and User Facility Device Experience (MAUDE) database of the U.S. Food and Drug Administration (FDA).

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A new device for the prevention of pulmonary embolism in critically ill patients: Results of the European Angel Catheter Registry

This study presents data from a European Registry of 60 critically ill patients in whom the IVC filter-catheter was used to prevent PE. The patients were all at high risk of PE development or recurrence and had contraindications to anticoagulation. The primary end points of this study were to evaluate the safety (in particular, the presence of infectious or thrombotic events) and effectiveness (the numbers of PEs and averted PEs) of the IVC filter-catheter.

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Pulmonary embolism – the future; Optimising the prevention of PE in the critically ill patient

Educational supplement for the UK’s Journal of the Intensive Care Society, sponsored by Bio2 Medical. Details the current clinical impact of Pulmonary Embolism (PE), current standards of care, and description of a new device for the prevention of PE including case studies.

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Angel® Catheter use for pulmonary embolism prophylaxis in a polytrauma patient

Objective: To describe the successful, clinical use of the Angel® Catheter, a device used for the prevention of pulmonary embolism (PE) and central venous access in a critically ill, multi-trauma patient.

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