• Biosense Webster (Diamond Bar, California) reports the launch of the EZ steer NAV bi-directional catheter, now available for use with the Carto XP system, a navigational system that provides real-time feedback in guiding the catheter to the target. The defining feature of this new bi-directional navigational catheter is it's the micro-tensioning system. With the micro-tensioning system physicians can, through a series of very small, continuous micro-movements, progressively dial in the precise force desired for deflection of the catheter. Because the micro-tensioning system can hold the deflection in place, there is no need for repeated locking and unlocking of the curve position. Biosense Webster makes diagnostic, therapeutic and mapping tools.

• Boston Scientific (Natick, Massachusetts) reported on data reflecting clinical event notification statistics from the first 10,000 patients monitored on the Latitude patient management system — a wireless remote monitoring of implantable cardiac devices. Remote monitoring between regularly scheduled follow-ups allows clinicians to observe changes sooner in their device patients and gives them the ability to intervene earlier where appropriate. The study showed that the Latitude patient management system detected 597 patients with sustained atrial arrhythmias for more than 24 hours and 968 patients who received shock therapy for spontaneous ventricular arrhythmias. Boston Scientific makes devices whose products are used in a broad range of interventional medical specialties.

• EDAP TMS (Lyon, France) reported the continuation of its U.S. Phase II/III clinical trial with treatment of an additional two patients. The study is currently enrolling men over age 50 diagnosed with clinical stage T1a, b or c or T2a localized prostate cancer. high intensity focused ultrasound (HIFU) is a noninvasive therapy using highly focused ultrasound energy to ablate the prostate tissue. EDAP TMS S.A. makes Ablatherm, used for treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option.

• Generic Medical Devices (GMD;Gig Harbor, Washington) reported that the FDA has cleared the GMD universal surgical mesh for market. The surgical mesh is a Class II, non-active implantable device intended to support tissue growth in open or laparoscopic procedures, which are common for hernia repair. Clearance of the GMD Universal Surgical Mesh is based on the device being substantially equivalent – having the same or equivalent materials, design specifications, technological characteristics, operation, intended use and performance — to pre-amendment devices and a product currently on the market. GMD makes surgical products marketed at generic prices.

• Ventracor (San Francisco) reported the presentation of summary clinical data of the first 100 patients implanted with the VentrAssist third-generation left ventricular assist device (LVAD), an implantable blood pump designed for long term use in patients with advanced heart failure. The data was presented at a plenary session of the 2007 annual meeting of the International Society of Heart and Lung Transplantation (ISHLT). Ventracor makes an implantable blood pump, the VentrAssist left ventricular assist device, as therapy to improve the lives of heart failure patients and their families.

• VNUS Medical Technologies (San Jose, California) reported the launch of the VNUS ClosureFAST catheter, for the treatment of the underlying cause of varicose veins. ClosureFAST is an endovenous radiofrequency ablation catheter that is designed to heat, shrink and close diseased saphenous veins (large leg veins) in three to five minutes of RF treatment — as fast as laser ablation devices — with minimal pain and bruising. The entire ClosureFAST procedure, from insertion of the catheter to removal, can now be completed in approximately 16 minutes — less than half the time required for previous RF-based procedures. VNUS Medical Technologies makes products for the minimally invasive treatment of venous reflux disease.