FDA Grants Abiomed Conditional Approval for Impella 2.5 Study
August 30, 2007 - Abiomed Inc. announced it has received conditional approval from the FDA to begin its pivotal clinical trial in the United States for the Impella 2.5 Circulatory Support System, after the company submitted clinical results of the safety pilot clinical trial. The approval is conditional upon the Company’s submission of additional information to the FDA over the next 45 days.
The study will determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP) during high-risk angioplasty procedures. The study inclusion criteria have been extended to include patients with triple vessel disease with low ejection fraction. The study is approved under category B2 status and the trial sites are eligible for full reimbursement from the Centers for Medicare and Medicaid Services (CMS).
The Impella 2.5 is a left percutaneous device inserted while in the cath-lab, which provides patients with up to 2.5 liters of blood flow per minute. According to the manufacturer, it is the world’s smallest VAD and has been used to treat conditions such as acute myocardial infarction (heart attack), cardiogenic shock and low output syndrome under CE Mark approval in Europe. Due to a rise in conditions such as triple vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three vessels of the heart, the Impella 2.5 provides a new treatment option that aims to improve patient outcomes.
For more information: www.abiomed.com
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