FDA approves Abbott's Omnilink Elite Vascular Balloon ... | 合法醫療器材資訊網

2012年8月8日—TheUSFoodandDrugAdministration(FDA)hasapprovedtheOmnilinkEliteVascularBalloon-ExpandableStentSystem(Abbott)forthe ...

The US Food and Drug Administration (FDA) has approved the Omnilink Elite Vascular Balloon-Expandable Stent System (Abbott) for the treatment of iliac arterial disease. The FDA approval is supported by positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro Stent used in the iliac artery) study. The MOBILITY study demonstrated that Omnilink Elite is safe and effective even in difficult-to-treat patients with severely calcified lesions. 

The Omnilink Elite stent is based on the proven, market-leading Multi-Link stent design with a next-generation cobalt chromium alloy. Cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the physician to navigate the stent in complex anato...