Reported at TCT 2012: InspireMD MGuard Stent Meets Primary Endpoint of MASTER Trial, Significantly Improving Prospects of Heart Attack Survival
MIAMI, October 24, 2012 /PRNewswire/ –
InspireMD, Inc. (OTC: NSPR) (“InspireMD” or the “Company”), announced its proprietary
MGuard(TM) Embolic Protection Stent (EPS) was shown to be significantly superior when
compared to standard bare metal and drug eluting stents in achieving complete ST
resolution and restoring normal blood flow in a major study of 432 randomized patients
undergoing emergency coronary intervention for potentially fatal heart attacks.
The data was reported at the Late Breaking Trials Session at the 24th Annual
Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting in Miami, FL today by
Gregg W. Stone M.D., the study’s chairman and the Director of the Cardiovascular Research
and Education Center for Interventional Vascular Therapy at New York-Presbyterian
Hospital/Columbia University Medical Center.
The findings show the novel MGuard EPS provides a significant acute advantage and, as
a result, may hold the potential to lower the incidence of adverse sequela and prolong
survival of heart attack victims.
The study met its primary endpoint (proportion of patients with ST segment resolution
ofgreater than or equal to 70%, measured at 60 to 90 minutes post procedure), showing the
MGuard EPS was significantly superior to the control arm of bare metal and drug eluting
stents in the treatment of heart attack patients.
— Significantly more patients treated with the MGuard EPS achieved complete ST
resolution (a measure of blood flow restoration to the heart muscle) compared to control
arm (57.8% vs. 44.7%, P=0.008), a relative improvement of 29 percent.
— When compared to control, the MGuard EPS showed a significant improvement in
coronary artery blood flow, including: (1) superior rates of restoring normal blood flow
(TIMI-3 flow) (91.7% vs. 82.9%, P=0.006, a relative improvement of 10.6%); and (2)
significantly less incomplete blood flow (TIMI-0/1 flow) post PCI (1.8% vs. 5.6%, P=0.01,
a relative improvement of 67.9%).
— The trial showed a trend toward lower mortality (0% vs. 1.9%, P=0.06) at 30 days
and smaller infarct size as measured by post procedure cardiac MRI (17.1gr vs. 22.3gr,
p=0.27) in the MGuard EPS arm versus control.
— There was no difference between the groups in the secondary endpoint of
myocardial blush grade (MBG), which is an angiographic measure of blood flow to the
cardiac muscle (MBG2/3 83.9% vs. 84.7%, P=0.81).
“I was impressed with the performance of the MGuard Embolic Protection Stent in the
MASTER trial,” said Dr. Stone. “Compared to standard stents, the MGuard is the first stent
in a randomized trial shown to restore complete ST-segment resolution in a higher
proportion of patients, a key predictor of myocardial salvage and long-term survival in
STEMI (ST segment elevation myocardial infarction) patients.”
The MGuard EPS is integrated with a precisely engineered micro net mesh that prevents
the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage
from breaking off.
Results Published In Journal of American Cardiology
The MASTER (MGuard for Acute ST Elevation Reperfusion) trial randomized 432 patients
to MGuard EPS (217) and to either bare metal or drug eluting stents (216). Fifty centers
in nine countries participated in the trial. Patients are being followed for one year.
Details of the MASTER trial were published online today in the Journal of American
College of Cardiology (JACC).
The authors concluded that “among patients with acute STEMI undergoing emergent PCI
enrolled in the present multicenter, randomized, controlled trial, the MGuard EPS micro
net covered stent compared to standard metallic stents resulted in superior rates of
epicardial coronary flow and complete STR, with trends present toward reduced
microvascular obstruction, infarct size and mortality.”
About Stenting And MGuard EPS
Stenting is a routine procedure for heart attack patients. It opens up the clogged
artery that caused the attack.
Standard stents weren’t engineered for heart attack patients. They were designed for
treating stable angina patients whose occlusion is different from that of an occlusion in
a heart attack patient.
In acute heart attack patients the plaque or thrombus is unstable and often breaks up
as the stent is implanted causing downstream blockages (some of which can be fatal) in a
significant portion of heart attack patients.
InspireMD’s solution is the MGuard EPS, a metal stent that’s secured inside a
proprietary knitted net made of micro polymer fibers, each thinner than a human hair.
The Micronet(TM) is designed to hold plaque or thrombus in place against the blocked
artery’s wall, preventing debris from entering the blood stream.
While offering superior performance relative to standard stents in STEMI patients, the
MGuard EPS requires no change in current physician practice – an important factor in
promoting acceptance and general use in time-critical emergency settings.
MGuard(TM) EPS is CE Mark approved.
Dr. Stone’s presentation, titled “A Prospective, Randomized Trial of PET Micronet
Mesh-Covered Stent vs. Standard Stents in Patients with ST-Segment Elevation Myocardial
Infarction, took place this morning in Miami, FL in the main arena of the TCT.
TCT (Transcatheter Cardiovascular Therapeutics) is the annual scientific symposium of
the Cardiovascular Research Foundation. TCT gathers leading medical researchers and
clinicians from around the world to present and discuss the latest developments in the
The Cardiovascular Research Foundation (CRF) is an independent, academically focused
nonprofit organization dedicated to improving the survival and quality of life for people
with cardiovascular disease through research and education. Since its inception in 1991,
CRF has played a major role in realizing dramatic improvements in the lives of countless
numbers of patients by establishing the safe use of new technologies, drugs and therapies
in interventional cardiovascular medicine. For more information about CRF, visit
About InspireMD, Inc.
InspireMD is a medical device company focusing on the development and
commercialization of its proprietary stent system technology, MGuard(TM). InspireMD
intends to pursue applications of this technology in coronary, carotid and peripheral
artery procedures. InspireMD’s common stock is quoted on the OTC under the ticker symbol
About MGuard(TM) Embolic Protection Coronary Stent
MGuard(TM) EPS combines a coronary stent merged with an embolic protection
specifically designed for acute MI patients. The embolic protection is comprised of an
ultra-thin polymer micron net that is integrated with the stent. The MGuard EPS is
designed to provide outstanding and lifelong embolic protection, without affecting
deliverability. MGuard EPS is CE Mark approved. MGuard(TM) is not approved for sales in
the U.S. by the U.S. Food and Drug Administration at this time.
This press release contains “forward-looking statements.” Such statements may be
preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar
words. Forward-looking statements are not guarantees of future performance, are based on
certain assumptions and are subject to various known and unknown risks and uncertainties,
many of which are beyond the Company’s control, and cannot be predicted or quantified and
consequently, actual results may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include, without limitation,
risks and uncertainties associated with (i) market acceptance of our existing and new
products, (ii) negative clinical trial results or lengthy product delays in key markets,
(iii) an inability to secure regulatory approvals for the sale of our products, (iv)
intense competition in the medical device industry from much larger, multi-national
companies, (v) product liability claims, (vi) our limited manufacturing capabilities and
reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement
by governmental and other third party payers for our products, (viii) our efforts to
successfully obtain and maintain intellectual property protection covering our products,
which may not be successful, (ix) legislative or regulatory reform of the healthcare
system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers
for certain product components, (xi) the fact that we will need to raise additional
capital to meet our business requirements in the future and that such capital raising may
be costly, dilutive or difficult to obtain and (xii) the fact that we conduct business in
multiple foreign jurisdictions, exposing us to foreign currency exchange rate
fluctuations, logistical and communications challenges, burdens and costs of compliance
with foreign laws and political and economic instability in each jurisdiction. More
detailed information about the Company and the risk factors that may affect the
realization of forward-looking statements is set forth in the Company’s filings with the
Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K,
its Transition Report on From 10-K/T and its Quarterly Reports on Form 10-Q. Investors and
security holders are urged to read these documents free of charge on the SEC’s web site at
[http://us.lrd.yahoo.com/SIG=117ej2487/EXP=1327079007/**http%3A/www.sec.gov ]. The Company
assumes no obligation to publicly update or revise its forward-looking statements as a
result of new information, future events or otherwise.
For additional information: InspireMD Desk at: Redington, Inc. +1-212-926-1733 +1-203-222-7399 email@example.com
SOURCE InspireMD, Inc.