FDA Approves Vascular Closure Device

The FDA has approved St. Jude Medical's 6F Angio-Seal device used to seal arterial punctures created during cardiology procedures. The CE Mark approval for the 6F Angio-Seal device was received in February 1999.

St. Jude Medical (St. Paul, MN) completed the acquisition of the Angio-Seal business from Tyco International in March 1999. The 8F Angio-Seal, developed by Kensey Nash Corp. and available in the U.S. since 1996, is a leading product in the estimated $165 million global vascular closure device market.

The 6F Angio-Seal device will address the largest segment of the vascular closure device market for punctures created during catheterization procedures. Approximately 70% of the seven million cardiac catheterization procedures performed worldwide each year are accomplished using a 6F or smaller puncture in the femoral artery. The 6F Angio-Seal product incorporates several product features to improve ease of use and clinical outcomes.

Michael J. Coyle, president of St. Jude Medical's Daig Division, said, "The approval of the 6F device is one of the final milestones for totally integrating Angio-Seal manufacturing into St. Jude Medical. In early December, we received approval from the FDA to manufacture the 8 French device in our Minnetonka facility. With the approval of the 6F, we can now manufacture all U.S. devices in this facility, facilitating the release of product enhancements at even a faster rate."

"During the past year, we launched two product enhancements to the 8 French Angio-Seal device with the ADV and ADV 2. We recently began clinical evaluation of the Angio-Seal STS. The STS design eliminates the need for the post placement spring and permits the entire closure procedure to be completed in the lab. In addition, we will soon initiate clinical evaluation of a new delivery system for both the 6F and 8F devices," Coyle continued.

Edited by Ursula Jones