Atrium Medical Announces 1-year results of the INFUSE-AMI Trial
HUDSON, N.H., May 3, 2013
HUDSON, N.H., May 3, 2013 /PRNewswire/ -- Atrium Medical Corporation, a
business unit of MAQUET Cardiovascular, today announced the 1-year results of
the INFUSE-AMI (Abciximab and Aspiration Thrombectomy in Patients With Large
Anterior Myocardial Infarction) trial. Dr. Gregg Stone, the principle
investigator, presented the exciting findings at the 62^nd Annual American
College of Cardiology Conference in San Francisco, CA.
INFUSE-AMI's primary endpoint was reduction in infarct size (also known as the
size of the heart muscle impacted by a heart attack) measured by the highly
sensitive cMRI, at 30-days in patients who were treated with intra-lesional
ClearWay™ RX /abciximab* versus those that did not receive intra-lesional
ClearWay RX/ abciximab.
At 30-days, the primary endpoint was achieved, and patients who were treated
with intra-lesional ClearWay RX/abciximab experienced a statistically
significant relative reduction in infarct size of 16%. Additionally, patients
in the ClearWay RX /abciximab arm showed a favorable trend in new onset of
severe heart failure in comparison to those patients that did not receive this
Clinical findings between 30-days and 1-year for patients who received
intra-lesional ClearWay RX/abciximab were strongly associated with better
outcomes, including significantly lower mortality rates and reduced major
adverse cardiac and cerebral events compared to patients who did not receive
Researchers also observed all mortality occurred in patients with an infarct
size greater than 17.1%** (the median infarct size in the INFUSE-AMI trial was
17.2%). The median infarct size for patients treated with ClearWay
RX/abciximab was 15.1%, whereas the median infarct size for patients who
received an alternative treatmentwas 17.9%. The INFUSE-AMI data shows a
relationship between infarct size and mortality. These clinical findings
correlate with other published studies and could explain some of the improved
results in those patients receiving intra-lesional abciximab via the ClearWay
RX drug delivery balloon.
Dr. Michael Gibson, Co-PI for the INFUSE-AMI trial, stated that "ClearWay
offers the interventionalists a reproducible, on the table treatment option
for the preservation of heart muscle, resulting in reduced clinical events,
and was associated with a mortality reduction in this mechanistic study."
About the ATRIUM MAQUET ClearWay™ RX Drug Delivery Balloon Catheter
The ClearWay RX local drug delivery balloon catheter is a thin, microporous
PTFE balloon mounted on a .014" rapid exchange catheter, FDA 510(k) & CE
cleared for the delivery of therapeutic and diagnostic agents in the coronary
and peripheral vasculature. The ClearWay RX balloon atraumatically occludes
blood flow during the local infusion, thus maximizing the therapeutic agent's
concentration and residence time enhancing the desired therapeutic effect.
ClearWay RX is available in 1.0 to 4.0 mm balloon diameters and in balloon
lengths ranging from 10 to 50 mm. As of October 1, 2012 the ClearWay RX drug
delivery balloon was added to the ACC guidelines as an approved device meeting
the criteria for "door to balloon" time (SEQ7050-51).
About Atrium Medical Corporation
Atrium Medical Corporation's vast expertise in medical device technologies for
the treatment of coronary and vascular disease, chest trauma, hernia and soft
tissue injury has brought a number of breakthrough advances in several
diversified healthcare markets including interventional cardiology and
radiology, chest trauma care and thoracic drainage, vascular surgery, and
general surgery. Maintaining a commitment to the latest ISO13485 Quality
Standards, state-of-the-art manufacturing and automation, cell biology and
biomaterial discovery programs, Atrium continues to excel in those healthcare
segments that require more advanced surgical intervention for improvements in
patient outcomes. Atrium is a business unit of MAQUET Cardiovascular, a member
of the GETINGE GROUP of companies. For more information please visit
MAQUET, a trusted partner for hospitals and physicians for over 175 years, is
the global leader in providing medical systems that meet the needs of the most
medically challenging patients, while exceeding the expectations of the
hospital teams that care for them. MAQUET designs, develops and distributes
innovative therapy solutions and infrastructure capabilities for high-acuity
areas within the hospital including the operating room (OR), hybrid OR/cath
lab and intensive care unit (ICU) as well as intra and inter hospital patient
Headquartered in Rastatt, Germany, MAQUET is the largest subsidiary of the
publicly listed Getinge Group AB of Sweden. MAQUET generated about 1.5 billion
Euros in 2012, representing more than half of the Getinge Group's annual
revenue of 2.7 billion Euros. MAQUET has 6,300 employees in 45 international
sales and service organizations, as well as a network of more than 300 sales
representatives. For more information please visit www.maquet.com.
MAQUET – The Gold Standard
*Abciximab, which is manufactured by Centocor Ortho Biotech and distributed by
Eli Lilly under the trade name ReoPro^®, is a platelet aggregation inhibitor
mainly used during and after coronary artery procedures such as angioplasty to
prevent platelets from sticking together and causing thrombus formation within
the coronary arteries. Abciximab is not indicated for intracoronary delivery.
**87% of patients received a cMRI.
SOURCE Atrium Medical Corporation
Contact: Kelly MacMillan, Director of Marketing Communications, Atrium Medical
Corporation, Phone: 603-880-1433 x5209, Fax: 603-880-4545, Email:
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