Studies Presented
at Heart Rhythm 2016 Provide Encouraging Results for ICD Lead
Placement Under Ribs, Outside Heart and Veins
DUBLIN and SAN FRANCISCO - May 6,
2016 - Medtronic plc (NYSE:MDT) today announced the results of
several studies evaluating a novel approach to implantable
cardioverter defibrillator (ICD) therapy at Heart Rhythm 2016, the
Heart Rhythm Society's 37th Annual Scientific Sessions in San
Francisco.
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 at HRS 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.
"While conventional ICDs are highly effective in
providing life-saving therapy for patients at risk of sudden
cardiac death, clinicians also are looking for an extravascular
solution that provides similar benefits as transvenous ICDs,
including pacing to terminate life-threatening heart rhythms," said
Joseph Chan, M.D., Prince of Wales Hospital, Hong Kong, who led one
of the studies presented today at Heart Rhythm. "The feasibility
results presented are encouraging and show that the EV-ICD approach
may be the solution physicians are seeking."
The investigational Medtronic EV-ICD system
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. Like 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.
In an oral abstract session, Dr. Chan presented
the results from a prospective, non-randomized study of 16 patients
scheduled to undergo a midline sternotomy or implant of an ICD, who
were enrolled at five sites in Europe and Hong Kong. Using an
introducer to guide the delivery of the defibrillation lead under
the rib cage, the study determined that defibrillation is possible
in this location with defibrillation results consistent with
conventional ICDs.
In a second oral abstract session, Darius
Sholevar, M.D., presented the results from a prospective,
multicenter trial that assessed the feasibility of cardiac pacing
from a lead placed outside the heart and under the rib cage (also
referred to as extravascular, or substernal space). Substernal
Pacing Acute Clinical Evaluation (SPACE) studied 26 patients from
eight sites in the U.S. and Canada, and preliminary data
demonstrated that pacing is possible from this extravascular space,
with the majority of patients achieving consistent and appropriate
ventricular pacing results.
These clinical data were further supported by
other pre-clinical abstracts presented during Heart Rhythm, which
assessed the feasibility of pacing and defibrillation with leads
outside the heart and under the rib cage.
-
Researchers developed a model to compare the
amount of energy required for effective defibrillation in
conventional ICDs, subcutaneous ICDs, and the investigational
EV-ICD approach. The model showed that lead placement under the rib
cage requires slightly more energy, on average, for defibrillation
compared to conventional ICDs, and about half as much, on average,
as current subcutaneous ICDs. These data were further supported by
a second abstract demonstrating that the EV-ICD approach requires
lower energy (defibrillation thresholds) than subcutaneous devices
and comparable energy to conventional ICDs.
-
A final abstract reinforced that pacing can be
achieved with the lead placed in this extravascular space.
"The EV-ICD may be transformational for ICD
therapy, with advancements for both patients and physicians," said
John Liddicoat, M.D., senior vice president, Medtronic, and
president of the Cardiac Rhythm and Heart Failure division. "These
feasibility study results are promising and have brought us one
step closer to making this approach a reality for patients around
the world 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-
1 Zipes, 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.
2 Volosin 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
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
HUG#2010196
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024