LOMBARD SUSPENDS STENT PROCEDURES

Lombard Medical Technologies announced Monday that it is temporarily suspending European clinical procedures involving its Generation II Aorfix endovascular stent graft following the discovery of a problem with the placement of the graft in a small number of patients.

According to the company, investigations found the problem related to a minor change in the manufacturing procedure of the delivery device for the stent graft.

The placement problem has no implication on the effectiveness or durability of the implants, the company said, adding that data indicate that the implant continues to perform well and that the deployment issue has not affected any patients.

Comprehensive testing of a corrective procedure will be completed over the next few weeks, the company said.

The company is recovering field stocks of the affected product from distributors. Clinical procedures involving the Generation I Aorfix device and the Aorfix Aorto-uni-iliac device are not affected, and trials in the United States of the Generation I device will also continue.