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
62nd 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
treatment.
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 ClearWay
RX/abciximab.
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
treatment was 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
www.atriummed.com.
About MAQUET
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 transport.
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
www.maquet.com
www.getingegroup.com
*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
