March 22, 2017
AUSTIN, TEXAS—On March 1, 2017, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center was the first in Texas and among the first facilities in the U.S. to use the FlexAbility™ Ablation Catheter, Sensor Enabled™, designed to improve versatility and precision during cardiac ablation procedures to treat atrial flutter, a type of irregular heartbeat. The FlexAbility Ablation Catheter, Sensor Enabled helps collect both electrical current resistance (impedance) and magnetic data to facilitate detailed, accurate mapping, as well as assist in the treatment of sites that trigger or sustain abnormal heart rhythms.
“This new catheter allows us to improve safety—and achieve greater accuracy—when treating complex cases,” Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI, said. “This results in optimal outcomes for our patients.”
When used with the EnSite Precision™ cardiac mapping system—a next-generation platform designed to provide automation, flexibility and accuracy for diagnostic mapping used in ablation procedures to treat patients with abnormal heart rhythms, or arrhythmias—Sensor Enabled catheters allow physicians to create highly detailed 3-D cardiac models with the heart’s electrical activity overlaid on it. These models help the physicians identify the type of arrhythmia and the areas they should treat with the ablation catheter.
The catheter is also compatible with MediGuide™ Technology, which allows the physician to reduce the duration of live X-ray during a procedure.
When physicians use catheter ablation to treat cardiac arrhythmias, several long, flexible tubes with wires, called catheters, are inserted into the heart. Diagnostic catheters record and “map” electrical information from the heart, and the EnSite Precision cardiac mapping system provides highly detailed anatomical models and maps to enable diagnosis of a wide range of arrhythmias, guide therapy and expand procedural options. Ablation catheters then deliver radiofrequency energy, and the heat from the catheter creates a lesion or scar on the tissue where the abnormal heartbeats originate. As a result, this tissue is no longer capable of conducting or sustaining the arrhythmia.
The FlexAbility Ablation Catheter, Sensor Enabled is based on the original FlexAbility ablation catheter platform, which featured the first irrigated flexible tip providing directed flow and tip temperature monitoring aimed at reducing procedural risk. The new enhanced FlexAbility Ablation Catheter, Sensor Enabled adds the ability to collect magnetic data, providing procedural versatility and precision when integrated with certain mapping and navigation systems.
The most common arrhythmia is Atrial Fibrillation, or A Fib, which affects more than 3 million Americans—and millions more worldwide. A Fib is a very fast, irregular heartbeat that occurs when the upper chambers of the heart beat so fast that they only can quiver. Left untreated, A Fib can cause a stroke.
The FlexAbility Ablation Catheter, Sensor Enabled was approved by the U.S. Food and Drug Administration in February 2017.