FDA approves new Lumen catheter size
The U.S. Food and Drug Administration (FDA) issued a final clearance for the medical device company Lumen Biomedical to market two additional sizes of its Xtract Aspiration Catheter in the United States.
Lumen said its Xtract Aspiration Catheter is designed to remove fresh, soft emboli or thrombi from the arterial system.
As a result of the recent clearance, the Xtract Catheter is now available in two larger sizes (5 and 5.8 French), making it the largest catheter of this type now on the market, according to the Plymouth, Mass.-based company.
In June 2006, the FDA granted clearance to the smaller catheter size (4.2F).
Lumen said its Xtract Aspiration Catheter is designed to remove fresh, soft emboli or thrombi from the arterial system.
As a result of the recent clearance, the Xtract Catheter is now available in two larger sizes (5 and 5.8 French), making it the largest catheter of this type now on the market, according to the Plymouth, Mass.-based company.
In June 2006, the FDA granted clearance to the smaller catheter size (4.2F).