Boston Scientific gets FDA approval for computer-mapping heart catheter
Boston Scientific
The FDA-approved catheters will be used with a mapping system that creates a computer model of the patient's heart.
Marlborough’s Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for two catheters that can be used with the company’s Rhythmia Mapping System to generate a 3d map of a patient’s heart to help diagnose, locate and treat the source of rhythm abnormality.
These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market, the company announced Wednesday. Along with the immediate launch of the catheters, the company is also releasing a software enhancement for the Rhythmia Mapping System that will allow for faster mapping of the heart.
"By combining these new magnetic navigation-enabled catheters with our high-density, high-resolution Rhythmia Mapping System, we can create enhanced maps,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific.
Unlike conventional cardiac mapping systems, the Rhythmia Mapping System rapidly and automatically generates three-dimensional images of any chamber of the heart. Both of the newly approved IntellaNav XP catheters feature magnetic sensors which track the location of the catheter while delivering radiofrequency energy into the heart muscle. This creates heat to destroy a small area of the tissue responsible for the abnormal heart rhythm.
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