FDA approves Medtronic ’ s Claria MRI quad CRT-D

Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its Claria MRI quad cardiac resynchronization therapy defibrillator for magnetic resonance imaging scans at both 1.5 and 3 Tesla. “The Claria MRI CRT-D is our latest innovation to help improve patients’ response to CRT, establishing a new level of personalized care,” heart failure GM Dr. David Steinhaus said in prepared remarks. “And it further expands our industry-leading MR-conditional portfolio of devices, which are helping to improve the lives of more patients throughout the world.” “Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven’t been able to determine if that stimulation actually improves the heart’s pumping ability,” added Dr. Suneet Mittal of Ridgewood, N.J.’s Valley Health System. “With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT.” Fridley, Minn.-based Medtronic said it’s also seeking a PMA for multiple-point pacing, saying it plans to offer the feature once approved for the Claria device and its Amplia MRI line of CRT-Ds. The post FDA approves Medtronic’s Claria MRI quad CRT-D appeared first ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news