Medtronic has secured approval from the US Food and Drug Administration (FDA) for its less-invasive heart pump implant procedure with HVAD system.
Image: Medtronic operational headquarters. Photo: courtesy of Medtronic.
The HVAD is a left ventricular assist device (LVAD) for the treatment of patients with advanced heart failure.
Thoracotomy is a small lateral and surgical incision between the patient’s ribs on the left side of the chest.
The approval for HVAD implantation via thoracotomy was based on data from the Lateral clinical study, which recruited 144 patients with end-stage heart failure at 26 centers in the US and Canada.
According to the company, the primary endpoint of the trial showed non-inferiority of the HVAD implanted in patients via thoracotomy, where survival at six months free from disabling stroke or device explant or exchange due to malfunction was achieved in 88.1% of patients.
Lateral trial principal investigator Dr Edwin McGee 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.”
The HVAD system is claimed to be the only LVAD approved in the US and Europe for implant via a thoracotomy and median sternotomy.
The system also secured approval for the treatment of patients with advanced and refractory heart failure as a bridge to cardiac transplantation. It can also be used as a destination therapy in patients for whom subsequent transplantation is not planned.
In the US and CE marked countries, Medtronic also provides new surgical implant tools designed to help physicians in the thoracotomy approach with the HVAD system.
Medtronic cardiac and vascular group’s heart failure business general manager and vice president Dr David Steinhaus said: “The thoracotomy approach showed significant improvements in patients’ quality of life and functional capacity, supported by strong safety and effectiveness data from the study.
“Further, the added flexibility for implant approach offers a unique advantage of the HVAD System.”
For heart failure treatment, Medtronic provides CRT devices such as MR-conditional CRT-Ds and CRT-P, mechanical circulatory support therapy for advanced heart failure patients and heart failure diagnostics.