Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
12 July 2018 - 1:03AM
HeartWare(TM)
HVAD(TM) System Only LVAD Approved for Implant via Thoracotomy or
Median Sternotomy
DUBLIN - July 11, 2018 -
Medtronic plc (NYSE: MDT) has received United States Food and Drug
Administration (FDA) approval for a less-invasive implant approach
of its HVAD(TM) System, a left ventricular assist device (LVAD) for
patients with advanced heart failure. The HVAD System is the
smallest commercially available LVAD, 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.
"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.
"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, M.D., 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."
The Medtronic portfolio of therapies, diagnostic
tools and services for patients suffering from heart failure
includes CRT devices, including MR-conditional CRT-Ds and CRT-Ps;
mechanical circulatory support therapy for advanced heart failure
patients; heart failure diagnostics; and meaningful expert analysis
through Medtronic Care Management Services.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services of
the highest quality that deliver clinical and economic value to
healthcare consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 86,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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