FDA clears Endosonics' Oracle-Micro catheter

Intraluminal ultrasounddeveloper Endosonics announced this month that the Food and DrugAdministration has cleared its Oracle-Micro catheter, which combinescoronary balloon angioplasty with ultrasound imaging. Endosonicsclaims that the product is the only device that can perform bothpercutaneous transluminal coronary angioplasty (PTCA) and intravascularultrasound on the same catheter.

In clinical studies the company submitted to the FDA, cardiologistsusing Oracle-Micro had different impressions of treatment successand in some cases changed therapy decisions compared to cardiologistswho used conventional angiographic imaging.

Gaining FDA approval for Oracle-Micro was not a cake walk,however. The agency earlier this year asked Endosonics to revisethe data in the application (SCAN 8/31/94). Endosonics won theagency's go-ahead within weeks of resubmitting the application,the company reported.

Endosonics plans limited shipments of the current version ofOracle-Micro to U.S. customers while it submits a series of PMAsupplements for the latest version of the product.