Technology | Ventricular Assist Devices (VAD) | July 17, 2018

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure

HeartWare HVAD system now approved for implant via thoracotomy or median sternotomy

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure

July 17, 2018 — Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The HVAD System is the smallest commercially available LVAD according to Medtronic, and the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest.

LVADs help the heart pump and increase the amount of blood that flows through the body. They are typically implanted via median sternotomy, a surgical procedure in which a vertical incision is made down the middle of the chest, after which the sternum (or breastbone) is divided.

FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for heart transplant, were enrolled at 26 centers in the U.S. and Canada. The primary endpoint of the trial demonstrated 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 percent of patients. Since the success outcome exceeded the pre-specified performance goal of 77.5 percent, the trial achieved its primary endpoint (p=0.0012). The key secondary endpoint revealed a significant reduction in total length of hospital stay, from an average of 26.1 days down to 18 days (p<0.001). Overall survival among patients receiving an HVAD via the thoracotomy procedure was 88.8 percent at one year.

Detailed outcomes of the LATERAL trial and its secondary endpoints were presented at The International Society for Heart and Lung Transplantation (ISHLT) 2018 Scientific Sessions, April 11-14 in Nice, France.

"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," said Edwin McGee, Jr., M.D., professor and director, Heart Transplant & Ventricular Assist Device Program, Loyola University Medical Center, Maywood, Ill., and principal investigator of the LATERAL trial. "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 HVAD System is the only LVAD approved in the U.S. and Europe for implant via a thoracotomy as well as a median sternotomy. It is approved to treat patients with advanced, refractory heart failure as a bridge to cardiac transplantation and as destination therapy in patients for whom subsequent transplantation is not planned.

In addition to this approval, new surgical implant tools tailored to assist physicians with the thoracotomy approach for the HVAD System are now available in the U.S. and in CE Marked countries.

For more information: www.medtronic.com

Related Content

Cardiac Dimensions Randomizes First Patient in CARILLON Trial of Mitral Contour System
News | Heart Failure | September 20, 2018
Cardiac Dimensions announced the company has randomized its first patient in the CARILLON Pivotal Trial.
Antithrombin Drug Ineffective in Heart Failure With Sinus Rhythm and Coronary Disease
News | Heart Failure | September 07, 2018
The antithrombin drug rivaroxaban does not reduce the risk of a composite endpoint of survival, myocardial infarction...
Tafamidis Improves Survival in Rare Heart Condition
News | Heart Failure | September 06, 2018
Tafamidis is the first treatment to improve survival and reduce hospitalizations in a rare heart condition called...
New Target for Treating Heart Failure Identified by Penn Medicine Researchers

Microtubules in heart cells from a healthy patient (left) and from a patient with heart failure. The dense network of detyrosinated microtubules impedes the motion of the failing heart cell during the heart beat. Credit: Ben Prosser lab, Perelman School of Medicine, University of Pennsylvania

News | Heart Failure | June 25, 2018
New research finds changes in cellular struts called microtubules (MT) can affect the stiffness of diseased human heart...
Gencaro Does Not Reduce Atrial Fibrillation Risk in Heart Failure Patients
News | Heart Failure | May 30, 2018
Data from the GENETIC-AF trial was presented in a “Late Breaking Clinical Trials” oral presentation at the European...
Cardiac Contractility Modulation Safe and Effective as Heart Failure Treatment

Image courtesy of Impulse Dynamics

News | Heart Failure | May 18, 2018
In a new study, cardiac contractility modulation (CCM) therapy was confirmed to significantly improve exercise...
V-Wave Closes $70M Financing to Support Pivotal Study of Heart Failure Therapy
News | Heart Failure | May 16, 2018
Israel-based V-Wave Ltd. recently closed a $70 million Series C financing for its proprietary, minimally invasive...
News | Heart Failure | May 14, 2018
Ancora Heart Inc. announced the expansion of the company’s U.S. feasibility study to evaluate the investigational...
Protein Clumping May Contribute to Heart Failure Development

A PET scan detects clumping proteins in rat hearts (top). The enlarged heart (right) is one with heart failure. Other PET scans showing blood flow in the rat hearts (bottom) show that the protein clumps aren't due to circulation problems. Image courtesy of Circulation Research, May 11, 2018.

News | Heart Failure | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
Overlay Init