Medtronic plc has won FDA clearance for its Cardioinsight noninvasive 3-D mapping system. The device, which has been approved in Europe for nearly five years, is used to improve the mapping of electrical disorders of the heart. The Dublin-based company first gained access to the device through its $93 million acquisition of Cleveland-based Cardioinsight Inc. (See Medical Device Daily, June 22, 2015.)

The device could become a safer and less costly alternative to traditional cardiac mapping procedures, which are typically accomplished by inserting a catheter into the heart via an artery or vein. The Cardioinsight system eliminates the invasive steps of this clinical procedure by using a 252-electrode sensor vest that is worn by the patient.

The noninvasive technology creates 3-D electroanatomic maps of the heart by collecting electrocardiogram signals from the chest, and combining these signals with data from a computed tomography scan of the heart. Medtronic said the system shifts mapping away from the electrophysiology lab, potentially saving time and enhancing the patient experience.

"Cardioinsight is the first commercially available cardiac mapping system in U.S. that allows for the noninvasive mapping of the electrical activity of the heart, including dynamic beat-to-beat map creation," said Tracy McNulty, a spokesperson for Medtronic told Medical Device Daily. "This technology enables the mapping of infrequent, complex and fibrillatory rhythms."

Medtronic said it will employ a strategic roll-out of the technology in the geographies where it is cleared.

In addition to the U.S., the newest addition of the Cardioinsight system is available in Thailand. Previous iterations of the system have been used in more than 1,600 patient cases, and have been featured in more than 120 peer-reviewed journals and presentations.

The device will be in the Medtronic AF Solutions business's portfolio in the Cardiac Rhythm and Heart Failure division.

Cardioinsight's approval comes on the heels of fairly disappointing 2Q17 earnings for Medtronic. The company reported sales growth of just three percent, with U.S. growth of 1 percent. Medtronic executives said the disappointing results were because of delays in product launches and shipments in the cardiovascular and diabetes segments resulted in slower revenue growth.

"In this particular quarter, there were enough gaps in the stream of product launches that weakness in cardiovascular therapies and diabetes translated into 3 percent top-line growth in constant currency – slightly shy of the mid-single digit rate management aims for," said Debbie Wang, an analyst with Morningstar.

Raj Denhoy, an analyst for Jefferies said the quarter "set back almost a year of progress" for the company and that the recent strong product cycles have waned and the company finds itself in a slower period before new things kick in."

The approval of Cardioinsight could be a fresh offering that could contribute to future sales growth. The product is different from Medtronic's current offerings and joins the firm's recently approved Minimed 670G, a hybrid closed loop insulin delivery system, as a unique device. (See Medical Device Daily, Sept. 29, 2016.)