St Jude Medical gains EU approval for cardiac mapping system
28 May 2009
St. Jude Medical, Inc. (NYSE:STJ) has gained European CE Mark
approval and first use of its EnSite Velocity cardiac mapping system.
This new system has been designed to help physicians more efficiently
diagnose and deliver therapy to treat abnormal heart rhythms.
Advancements in the EnSite Velocity System’s design are focused on
increasing procedural efficiency, from set-up and operation, to clinical
application and use.
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.
The OneMap tool enables physicians to simultaneously create a
detailed cardiac model and electrical map 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, giving
physicians 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 EnSite Velocity System allows me to efficiently collect
anatomical and mapping data with whichever catheter I believe is most
appropriate for the procedure. The system’s versatility and catheter
choice is important, providing me with enhanced control during the
procedure,” said Tony Chow MD, of The Heart Hospital in London.
The new EnSite Velocity System incorporates significant improvements
into the design. The EnSite Velocity System continues its longstanding
ability to visualize multiple catheters and electrodes 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.
Additionally, 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
“The EnSite Velocity System functions as though it were designed with
the entire lab in mind; the simple setup and intuitive operation are
incredibly helpful in supporting efficient procedural workflow,” said
Christopher Piorkowski MD, of Herzzentrum Leipzig in Leipzig, Germany.
“Because my practice has a fast-growing population of patients to serve,
such efficiency gains benefit not only my patients but also other
members of my team.”
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 deliver therapy for abnormal heart rhythms. Like
previous models of the EnSite System, the EnSite Velocity System allows
catheter navigation to occur without fluoroscopy, thus reducing
potential for risks associated with excessive exposure to X-rays.
“The EnSite Velocity Cardiac Mapping System delivers the outstanding
performance of the EnSite System, but with a new level of procedural
efficiency,” said Jane J. 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 designed to
integrate seamlessly with existing lab technology, while having built-in
flexibility to allow for integration with future technologies.”
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