• Cordis (Miami Lakes, Florida), a Johnson & Johnson company, reported that it has filed a premarket approval submission (PMA) with the FDA for an in-stent restenosis indication for the Cypher Sirolimus-eluting Coronary Stent. The foundation for the PMA was data from the SISR Trial (A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents), which showed that patients who received the Cypher stent had a significantly lower incidence of target vessel failure defined as cardiac death, heart attack, or the need to re-open the artery, compared with patients who received brachytherapy.

• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance of the EnSite System Version 6 software, which provides improved clinical capabilities for cardiac mapping and navigation during electrophysiology (EP) procedures. Version 6 is designed to provide highly detailed, 3-D cardiac models at the time of an EP procedure. Physicians create the 3-D model in small sections that join together automatically. The models are then used by physicians to collect information about the heart's electrical activity and assist them in diagnosing and treating many arrhythmias. The software also includes an easier-to-use interface and other improvements. The company also has introduced new EnSite System software modules, including an advanced electrogram analysis tool that will support emerging approaches in the diagnosis and treatment of atrial fibrillation. St. Jude Medical said it is the first company to offer remote technical support on a cardiac mapping system through its EnSite connect remote support service.