Medtronic receives FDA approval for less invasive heart failure device

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Medtronic has received FDA approval for a device designed for a less invasive approach for patients with advanced heart failure.

The company’s HVAD System is a left ventricular assist device (LVAD) which helps the heart pump and increase the amount of blood that flows through the body. The system is the smallest commercially available LVAD and the only such device approved in the US for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest.

LVADs are typically used during a surgical procedure in which a vertical incision is made down the middle of the chest, after which the sternum is divided.

The device was approved based on data from the Lateral prospective clinical trial, which included 144 patients with end-stage heart failure. The trial demonstrated that 88% of patients with the HVAD implant survived for one-year. The trial also revealed a significant reduction in hospital stay for those with the implant, down from 26 days to 18 days.

Edwin McGee, principal investigator of the Lateral Trial, said: “We have demonstrated that a thoracotomy is a safe and effective implant technique for the HVAD System, which gives physicians added flexibility in treating a broad range of patients. Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant. It also has been shown to result in shorter hospital stays.”

"The thoracotomy approach showed significant improvements in patients' quality of life and functional capacity, supported by strong safety and effectiveness data from the study," said David Steinhaus, vice president and general manager of the Heart Failure business, which is part of the Cardiac and Vascular Group at Medtronic. "Further, the added flexibility for implant approach offers a unique advantage of the HVAD System."

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