FDA Approves Medtronic plc (NYSE:MDT) Claria MRI Quad CRT-D SureScan

The US Food and Drug Administration (FDA) has recently granted Medtronic plc (NYSE:MDT) the approval for the Claria Magnetic Resonance Imaging (MRI) Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan for patients with heart failure conditions.

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Claria MRI Quad CRT-D SureScan Approval

The device boasts EffectivCRT, an algorithm that automatically adjusts pacing rates to provide personalized therapy. It has been approved for scanning in 1.50 and 3 Tesla (T) MRI devices.

The Claria MRI Quad CRT-D SureScan is the first approved device capable of automatically adjusting pacing to provide improved treatment for patients. Most heart failure patients receiving CRT have atrial fibrillation (AF), which can negatively affect patients’ response to the treatment. With EffectivCRT, the pacing is automatically adjusted in accordance to AF without affecting patients’ normal heart rate.

“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,” reiterated Suneet Mittal, M.D., Arrhythmia Institute of the Valley Health System Director of Electrophysiology Laboratory.

Other interesting features of the device include the AdaptivCRT, an algorithm minimizing a patient’s risk of a 30-day heart failure readmission and AF risk; VectorExpress 2.0, an automated test reducing lead programming to two minutes; Attain Perfoma MRI SureScan Quadripolar Leads, which reduces phrenic nerve stimulation occurrence; SureScan MR-conditional labeling, which facilitates full-body scans without restrictions.

43rd Annual Symposium of Vascular and Endovascular Issues (VEITHsymposium) Presentation

On Tuesday, Medtronic is to begin delivering presentations of clinical trials involving endovascular treatments among core and complex aortic patients at the 43rd VEITHsymposium, the largest vascular surgical medicine educational symposium in the world.

The company will present new and/or updated data from the ENGAGE Global Registry, ANCHOR Registry, PROTAGORAS clinical trial, and on the Valiant Captivia system. Presentations involving the Valiant Mona LSA, Valiant EVO thoracic stent graft system, Valiant TAAA stent graft system, and Valiant ascending stent graft system are also included.

Medtronic has lost 4.05% on Monday, closing at $78.75.

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