St. Jude Medical (St. Paul, Minnesota) reported FDA clearance and the U.S. launch of its EnSite Velocity Cardiac Mapping System. The company says this new system has been designed to help doctors more efficiently diagnose and guide therapy to treat abnormal heart rhythms.

According to St. Jude, advancements in the design of the EnSite Velocity System increase procedural efficiency and speed, making it easier to use from set-up and operation, to clinical application. With new hardware and software, the system offers simple set-up and connections, an intuitive software interface and includes two key new capabilities: the OneMap tool and RealReview function, St. Jude said. The OneMap tool is designed to enable physicians to create a detailed cardiac model and electrical map together using multiple catheters and electrodes, allowing physicians to collect and display more relevant patient information in a shorter amount of time. The RealReview function provides real-time, side-by-side views of the live procedure and previously recorded portions of the procedure. This feature gives doctors a quick and easy comparison of events and results at different times throughout the procedure, without losing the ability to visualize and navigate catheters in real-time, the company noted. The EnSite Velocity System is an open platform, which means that it is compatible with essentially all diagnostic and ablation catheters, recording systems and energy sources used for ablation procedures.

Sara Spafford, a St. Jude spokeswoman, told Medical Device Daily that the EnSite Velocity System provides 3-D mapping and modeling of both the anatomy and the electrical system of the heart, which she says is important in treating atrial fibrillation and is one of the things that make the system unique. She called it a "one-step multipoint mapping tool."

Spafford also said that the EnSite Velocity System is the only open platform mapping system on the market. "Physicians can use the EnSite Velocity System with any number of catheter ablation systems, they don't have to use a St. Jude catheter system. It enables that physician choice," she said.

"We have been using the EnSite System for nearly ten years because of its ability to display and map electrical signals from multiple catheters and electrodes, and its convenience of being an open platform," said Walid Saliba, MD, of the Cleveland Clinic Foundation. "The next-generation EnSite Velocity System also allows us to treat patients with any arrhythmia and navigate the heart with potential reduction in procedural time."

St. Jude reported European CE-mark approval and the first use of the EnSite Velocity System in May (Medical Device Daily, May 14, 2009). The company also featured the system in May at the Heart Rhythm Society (Washington) scientific sessions in Boston.

The new EnSite Velocity System maintains the strengths and clinical utility that have made the EnSite System, which the company touts as "the leading cardiac mapping system," while incorporating significant improvements into the design. The EnSite Velocity System also continues EnSite's longstanding ability to reduce fluoroscopy exposure and is the only mapping system capable of supporting both contact and non-contact mapping, giving the EnSite Velocity System unmatched versatility in its ability to map any arrhythmia.

"This system has exceptionally detailed chamber models and clear electroanatomical maps," said Javier Sanchez, MD, of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center (Austin, Texas). "Compared to other systems, I found the user interface to be very intuitive, quick and easy to learn."

The EnSite Velocity System is used in minimally invasive electrophysiology procedures. Catheters with electrodes are inserted into a cardiac chamber; these electrodes are then located or visualized by the system, which records electrical information from the heart and displays it in a three-dimensional anatomical model. These highly detailed anatomical models, or maps, enable physicians to diagnose and guide therapy for abnormal heart rhythms.

Also important about the EnSite Velocity System, Spafford said, is that it has been demonstrated to help reduce fluoroscopy use during the procedure. "The less radiation that physicians and their patients are exposed to the better," she said.

"St. Jude Medical has been dedicated to finding a cure for AF for more than 15 years," said Jane Song, president of the St. Jude Medical Atrial Fibrillation Division. "As the next generation in cardiac navigation and visualization technology, the EnSite Velocity System is another demonstration of our company's commitment to continuous innovation in meeting the needs of electrophysiologists."

Amanda Pedersen, 229-471-4212;

amanda.pedersen@ahcmedia.com