FDA News

Noninvasive 3D mapping system for arrhythmia location cleared by FDA

Medtronic announced that the FDA has granted 510(k) clearance to its noninvasive 3D mapping system for procedures for patients with arrhythmia disorders.

Cardiac mapping has typically been managed by inserting a catheter into the heart using an artery or vein, but the system (CardioInsight) is the world’s first commercially available noninvasive 3D mapping system, Medtronic stated in a press release.

“By offering this noninvasive approach, we are effectively streamlining the clinical procedure planning process for clinicians and making it easy for patients to receive precise mapping results from their providers right at their bedside,” Vivek A. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital and Mount Sinai Health System, said in the release. “This system shifts mapping away from the [electrophysiology] lab, potentially saving time and enhancing the patient experience.”

Vivek Y. Reddy, MD
Vivek A. Reddy

According to the release, using a 252-electrode sensor vest worn by the patient, the system pairs body surface electrical data with heart-torso anatomy and creates 3D electroanatomic maps of the heart to collect ECG signals from the chest. These signals are then combined with data from a CT scan of the heart.

By contouring to the patient’s body, the system allows for continuous and simultaneous panoramic mapping of both atria or both ventricles, which cannot be accomplished by current invasive methods, according to the release.

Additionally, the system can enable rapid mapping of heart rhythms from a single heartbeat, Medtronic stated.

Disclosure: Reddy reports receiving research grant support from and consulting for Medtronic.

Medtronic announced that the FDA has granted 510(k) clearance to its noninvasive 3D mapping system for procedures for patients with arrhythmia disorders.

Cardiac mapping has typically been managed by inserting a catheter into the heart using an artery or vein, but the system (CardioInsight) is the world’s first commercially available noninvasive 3D mapping system, Medtronic stated in a press release.

“By offering this noninvasive approach, we are effectively streamlining the clinical procedure planning process for clinicians and making it easy for patients to receive precise mapping results from their providers right at their bedside,” Vivek A. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital and Mount Sinai Health System, said in the release. “This system shifts mapping away from the [electrophysiology] lab, potentially saving time and enhancing the patient experience.”

Vivek Y. Reddy, MD
Vivek A. Reddy

According to the release, using a 252-electrode sensor vest worn by the patient, the system pairs body surface electrical data with heart-torso anatomy and creates 3D electroanatomic maps of the heart to collect ECG signals from the chest. These signals are then combined with data from a CT scan of the heart.

By contouring to the patient’s body, the system allows for continuous and simultaneous panoramic mapping of both atria or both ventricles, which cannot be accomplished by current invasive methods, according to the release.

Additionally, the system can enable rapid mapping of heart rhythms from a single heartbeat, Medtronic stated.

Disclosure: Reddy reports receiving research grant support from and consulting for Medtronic.