TEL AVIV, Israel
November 5, 2012
InspireMD, Inc. ("InspireMD" or the "Company") (OTC: NSPR) announced today that the randomized 432-patient MASTER trial of its embolic protective MGuard stent will be published in the
November 6, 2012
print edition of the peer-reviewed
Journal of American College of Cardiology
Vol. 60, No. 19.
The online version of the paper, authored by
Gregg W. Stone
, MD and others, appeared a week ago Wednesday (
, coinciding with Dr. Stone's presentation of the findings at the Late Breaking Clinical Trials session of the 24
Annual Transcathater Cardiovascular Therapeutics (TCT) scientific meeting in
The findings showed the novel MGuard EPS provided a statistically and clinically 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.
MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the Food and Drug Administration (FDA) at this time. The Company plans to initiate a FDA approval study in 1Q 2013.
The study met its primary endpoint (proportion of patients with ST segment resolution of ≥ 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 the control arm (57.8% vs. 44.7%, P=0.008), a relative improvement of 29 percent.
-- The MGuard EPS showed a significant improvement in coronary artery blood flow compared with the control, 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%).