Medtronic First to Receive European Approval for Less-Invasive HVAD® Implant Procedure
November 29 2016 - 9:00AM
New Implant Option
Gives Physicians Surgical Alternative for Patients with Advanced
Heart Failure
DUBLIN - Nov. 29, 2016 -
Medtronic plc (NYSE: MDT) today announced that its HVAD® System
left ventricular assist device (LVAD) received CE (Conformité
Européenne) Mark for a less-invasive implant procedure in patients
with advanced heart failure. The HVAD System is the only
centrifugal LVAD approved in the European Union for implantation
via this new thoracotomy procedure.
Compared to the standard LVAD surgical implant
technique, the new approach uses a smaller incision1,2, potentially
lessens surgical bleeding1,3 and related
blood transfusions1, potentially
reduces the development of right heart failure1,4 and may
result in shorter hospital stays5. The
thoracotomy implantation technique may allow the area around the
heart to remain largely intact, potentially preserving the sternum
for future procedures or a heart transplant.1
"The HVAD System's small size makes it well-suited
for routine thoracotomy implantation," said Jan Schmitto, M.D.,
Ph.D., director of the Mechanical Circulatory Support Program and
cardiothoracic surgeon at Hannover Medical School, Hannover,
Germany, which helped pioneer the new procedure. "This
less-invasive implant procedure potentially enables faster patient
recovery compared to the traditional approach, which may help
improve patient outcomes."
The HVAD System features the HVAD® Pump, which is
smaller than other commercially available devices, and which more
easily enables implantation through a small, lateral thoracotomy
incision between a patient's ribs on the left side of the
chest.
"The HVAD System is the only full-support,
centrifugal LVAD approved in Europe for thoracotomy implantation,
providing clinicians with greater freedom to choose the best
surgical technique for each patient," said David Steinhaus, M.D.,
vice president and general manager of the Heart Failure business,
and medical director of the Cardiac Rhythm and Heart Failure
division at Medtronic. "CE Mark for the thoracotomy procedure is a
testament to the HVAD System's flexibility and versatility, and may
enable more patients to receive the life-sustaining benefit of the
device for the treatment of advanced heart failure."
A study of the thoracotomy HVAD procedure is
underway in Canada and the U.S., where the implant procedure
currently is not approved. The LATERAL(TM) Study is the largest
prospective clinical trial of a full-support ventricular assist
device (VAD) to evaluate this implant technique. The study includes
patients with end-stage heart failure who have not responded to
standard medical management and who are eligible for heart
transplantation.
The HVAD System features the world's smallest,
full-support centrifugal circulatory assist device, the HVAD Pump,
which is designed to be implanted next to the heart in the
pericardial space. The HVAD System received CE Mark in the European
Union in 2009, and was approved by the U.S. Food and Drug
Administration in 2012 as a bridge to cardiac transplantation for
patients who are at risk of death from refractory end-stage left
ventricular heart failure. Today, more than 11,000 patients with
advanced heart failure have received the HVAD System.
The Medtronic heart failure portfolio includes
leading cardiac resynchronization therapies, including the first
MR-conditional CRT-defibrillators in the U.S., mechanical
circulatory support therapy and impactful heart failure diagnostics
and expert analysis through Medtronic Care Management Services.
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 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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-
1 Schmitto,
J. Implantation of a centrifugal pump as a left ventricular assist
device through a novel, minimized approach: Upper hemisternotomy
combined with anterolateral thoracotomy. J Thorac
Cardiovasc Surg 2012;143:511-513
2 Deuse,
T. and Reichenspurner, H. Do Not Touch the Sternum-Thoracotomy
Incisions for HVAD Implantation. ASAIO Journal
2014;60:234-236
3 Popov,
AR. HeartWare left ventricular assist device implantation through
bilateral anterior thoracotomy. Ann Thorac
Surg 2012;93:674-6
4 Meyer,
AL.Minimal-invasive LVAD implantation, is it safe or even better?
J Heart Lung Transplant 2013;32
5 Rojas,
S. Chronic ventricular assist device support: surgical innovation.
Curr Opin Cardiol 2016;31:308-213
Contacts:
Hailee Tellier
Public Relations
+1-508-361-6722
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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