Abiomed’s Minimally Invasive Cannula Gets FDA Approval
Abiomed, Inc. announced yesterday FDA approval of its Premarket Approval Application (PMA) supplement for its new integrated cannula system. The new cannula has the potential for off-pump use with minimally invasive procedures and is designed to integrate with Abiomed’s AB5000 (pictured) and BVS 5000 circulatory support systems. It is easier to implant and explant and will save patients from requiring a second sternotomy during off-pump explantations. Off-pump “beating heart” techniques provide potential patient benefits of a shorter hospital stay and recovery time, as well as reduce bleeding, potential for infection, and trauma. The new cannula system consists of a 42 French cannula, surgical sewing cuff and an inline connector for precise implantation and reduced blood loss for patients in acute heart failure.
July 12, 2006 Related topics: Product Approval & Certification, Cardiology