FDA News

FDA approves less-invasive LVAD for advanced HF

Medtronic announced that a left ventricular assist device for the treatment of patients with advanced HF has received approval from the FDA.

The approval of the LVAD (HeartWare HVAD, Medtronic) was based on data from the LATERAL trial, according to a press release from the company.

As Cardiology Today previously reported, patients with end-stage HF who have had a ventricular assist device implanted by a thoracotomy procedure had similar survival and adverse event profiles compared with historical data of patients who had the device implanted by a standard sternotomy approach.

“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,” Edwin McGee Jr., MD, professor and director of the heart transplant and ventricular assist device program at Loyola University Medical Center in Maywood, Illinois, said in the press release. “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.”

This is the only LVAD approved in the United States that can be implanted via thoracotomy, according to the press release.

“The thoracotomy approach showed significant improvements in patients’ quality of life and functional capacity, supported by strong safety and effectiveness data from the study,” David Steinhaus, MD, a vice president and general manager at Medtronic, said in the press release. “Further, the added flexibility for implant approach offers a unique advantage of the HVAD system.”

Disclosures: The LATERAL trial was sponsored by Medtronic, formerly HeartWare Inc. Steinhaus is an employee of Medtronic. McGee reports he is a surgical proctor for Medtronic.

Medtronic announced that a left ventricular assist device for the treatment of patients with advanced HF has received approval from the FDA.

The approval of the LVAD (HeartWare HVAD, Medtronic) was based on data from the LATERAL trial, according to a press release from the company.

As Cardiology Today previously reported, patients with end-stage HF who have had a ventricular assist device implanted by a thoracotomy procedure had similar survival and adverse event profiles compared with historical data of patients who had the device implanted by a standard sternotomy approach.

“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,” Edwin McGee Jr., MD, professor and director of the heart transplant and ventricular assist device program at Loyola University Medical Center in Maywood, Illinois, said in the press release. “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.”

This is the only LVAD approved in the United States that can be implanted via thoracotomy, according to the press release.

“The thoracotomy approach showed significant improvements in patients’ quality of life and functional capacity, supported by strong safety and effectiveness data from the study,” David Steinhaus, MD, a vice president and general manager at Medtronic, said in the press release. “Further, the added flexibility for implant approach offers a unique advantage of the HVAD system.”

Disclosures: The LATERAL trial was sponsored by Medtronic, formerly HeartWare Inc. Steinhaus is an employee of Medtronic. McGee reports he is a surgical proctor for Medtronic.