Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its CardioInsight Noninvasive 3D mapping system, which was designed to map irregular heart rhythms in the upper and lower chambers of the heart and provide electroanatomic 3D maps of the heart.
The CardioInsight system is the 1st commercially available, noninvasive cardiac electrical mapping system in the world, according to Medtronic, and avoids the invasive steps of a traditional procedure to determine the origin of a patient’s irregular heart rhythm.
Medtronic’s 3D cardiac mapping system employs a 252-electrode sensor vest, which is worn by the patient. The technology captures electrocardiogram signals from the chest and combines them with data from a CT scan of the heart.
The vest allows for simultaneous panoramic mapping of both atria or both ventricles, which cannot be done using conventional invasive techniques. Capturing a single heartbeat is enough to create a 3D map, according to Medtronic.
“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,” Dr. Vivek Reddy, director of cardiac arrhythmia services at the Mount Sinai Hospital, said in prepared remarks. “This system shifts mapping away from the EP lab, potentially saving time and enhancing the patient experience.”
Medtronic, which acquired CardioInsight in 2015, plans to strategically roll out its cardiac mapping system in the places where it is cleared.
“The CardioInsight system further expands the portfolio of solutions available for common and complex arrhythmias,” Medtronic’s AF Solutions business VP & general manager Colleen Fowler added. “This technology – which has been in development for decades – is now poised to drive greater physician insights and new advancements in the study and treatment of infrequent, unstable cardiac rhythms in a noninvasive, patient-friendly manner.”
Yesterday, Bloomberg reported that Medtronic is working with advisors for a possible sale of its medical supplies business.
The process is reportedly still in an early stage, but the company has been on the hunt for prospective buyers for the division, which could be worth $5 billion.