Pulmonary Embolism Clinical Trial
Official title:
Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)
The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.
Despite advances in prophylaxis, diagnostic modalities, and therapeutic options, pulmonary
embolism remains a commonly under diagnosed and lethal entity. In the United States
approximately 150,000 patients per year are diagnosed with acute pulmonary embolisms. Many
additional deaths occur each year in the United States as a result of undiagnosed massive
pulmonary embolisms. Taking these patients into account, it is thought that up to 600,000
patients develop a pulmonary embolism annually in this country. In patients with acute
pulmonary embolism, the most common cause of early death is right ventricular failure.
In addition to anticoagulation therapy, several reperfusion therapies are being used to
reverse right ventricular failure: systemic thrombolysis, surgical embolectomy, and catheter
based therapy. Given the drawbacks of systemic thrombolytic therapy or surgical embolectomy,
percutaneous catheter treatment is a reasonable alternative for patients with
contraindications to systemic thrombolytic therapy or surgery. Current international
consensus guidelines support the use of catheter interventions for selected pulmonary
embolism patients at increased risk of adverse clinical outcomes.
The AngioJet Ultra PE Thrombectomy catheter introduces a pressurized high velocity saline
stream through a catheter tip so that the clot within a blood vessel is trapped, broken into
small pieces and aspirated from the body.
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