Medtronic Announces Results of Early Feasibility Studies Supporting New Approach to ICD Therapy During Cardiostim 2016
June 08 2016 - 8:00AM
Places ICD Leads
Under Rib Cage, Outside Heart and Veins
DUBLIN and NICE, FRANCE - JUNE 8,
2016 - Medtronic plc (NSYE: MDT) today announced results from
several feasibility studies evaluating a new approach to
implantable cardioverter defibrillator (ICD) therapy at CARDIOSTIM
/ EHRA EUROPACE 2016, the World Congress in Electrophysiology and
Cardiac Techniques, in Nice, France.
The Medtronic EV-ICD System, which currently is in
development and not available for use or sale, is a new approach to
ICD therapy with leads placed outside the heart and veins, and
under the rib cage. The studies presented are the first to evaluate
the new concept, and the results demonstrate that "extravascular"
lead placement may provide the same benefits achieved with
conventional ICDs, including pacing the heart in patients at risk
of dangerous heart rhythms.
"Physicians are interested in an ICD with a similar device
footprint and performance profile of conventional ICDs - but
without the need for vascular access - and these study results are
encouraging," said Francis Murgatroyd, M.D., consulting
cardiologist and director of Cardiac Electrophysiology at King's
College Hospital in London. "We look forward to further assessing
the benefits of the EV-ICD approach in order to make this important
advancement a reality for physicians and patients worldwide."
The Medtronic EV-ICD system in development
consists of an implanted device, a newly designed lead, and
procedure tools to guide the efficient delivery of the system. Like
conventional ICDs, the system is designed to deliver life-saving
electrical shocks to protect patients from sudden cardiac death, to
deliver anti-tachycardia pacing (ATP) to pace the heart out of
potentially life-threatening heart rhythms that can lead to sudden
cardiac death, and to provide post-shock pacing. Similar to
transvenous ICD systems, the Medtronic EV-ICD is projected to have
longevity of approximately 10 years and an expected device volume
of approximately 33 cc. In addition to these potential benefits,
the EV-ICD approach is designed to prevent the rare, but
potentially serious, risks that can occur when leads are implanted
inside the vasculature and the heart.
The data presented at CARDIOSTIM 2016 assessed the
feasibility of pacing and defibrillation with leads outside the
heart and under the rib cage:
-
Substernal Pacing Acute Clinical Evaluation
(SPACE) studied 26 patients from eight sites in the U.S. and
Canada, with preliminary data demonstrating that pacing is possible
from a lead placed outside the heart and under the rib cage (also
referred to as extravascular space), with the majority of patients
achieving consistent and appropriate ventricular pacing
results.
-
Results from a prospective, nonrandomized study
of 16 patients scheduled to undergo a midline sternotomy and
implant of an ICD demonstrated that defibrillation is possible with
the lead placed under the rib cage, and energy levels that are
consistent with conventional ICDs.
-
Anatomical analysis of CT scans from 68 patients
with cardiovascular disease found that, despite considerable
variations in patient anatomy, placement of a lead between the rib
cage and heart should be feasible with limited interactions with
the lungs.
-
A final abstract demonstrated that the EV-ICD
approach requires lower energy (defibrillation thresholds) than
subcutaneous devices, and comparable energy to conventional
ICDs.
"Medtronic is continuously working to accelerate
the development of meaningful innovations that improve patient
outcomes," said John Liddicoat, M.D., senior vice president,
Medtronic, and president of the Cardiac Rhythm and Heart Failure
division. "These studies not only demonstrate the feasibility of
this new approach, but also reinforce the broader sentiments from
the physician community that innovation is needed for patients at
risk of sudden cardiac death."
Sudden cardiac arrest is an abrupt loss of heart
function that can result in death if not treated within minutes.
Conventional ICDs involve leads (thin wires) connected to the heart
to deliver shocks or ATP that restore normal heart rhythms. ICDs
are proven to be 98 percent effective in treating dangerous
ventricular arrhythmias that can lead to sudden cardiac
arrest.1,2
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
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 85,000 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-
1Zipes, DP,
Roberts, D. for the Pacemaker-Cardioverter-Defibrillator
investigators. Results of the International Study of the
Implantable Pacemaker Cardioverter-Defibrillator: A Comparison of
Epicardial and Endocardial Lead Systems. Circulation. 1995;92:59-
65.
2Volosin et al.
"Virtual ICD: A Model to Evaluate Shock Reduction Strategies."
Heart Rhythm. Vol. 7, N. 5, May supplement 2010. (PO3-125).
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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