Boston Scientific Relaunches Coronary Stent

The FDA has approved Boston Scientific's NIR with SOX over-the-wire coronary stent system. The device had been voluntarily recalled by the company in October 1998—about six weeks after its launch—due to reports of balloon leakage in some units (see original story).

According to the company, the new process and design changes have been rigorously tested and validated.

The stent was developed and is manufactured by Medinol Ltd. of Tel Aviv, Israel. Boston Scientific (Natick, MA) has an exclusive worldwide marketing and distribution license for the product.

Edited by Ursula Jones