Expanding its portfolio of medical
technology for the interventional treatment of cardiovascular disease,
Medtronic MDT announced today that the Export Advance
aspiration catheter recently received the CE (Conformité
Européenne) mark and will soon be launched in Europe and other
international markets.
The new thrombus removal system from the market leader in the product
category offers superior deliverability en route to the aspiration site.
The Export Advance aspiration catheter is not approved for use in the
United States. The latest addition to the Export family of aspiration
catheters will be on exhibit during EuroPCR (May 21-24 in Paris) at the
Medtronic booth.
"When thrombus completely or partially blocks an artery, aspiration is
an important first step of the treatment process that can improve
clinical outcomes," said Dr. Sanjit Jolly, an associate professor of
cardiology at Canada's McMaster University in Hamilton, Ontario, and an
interventional cardiologist at Hamilton Health Sciences.
"Removing thrombus with highly effective aspiration catheters, such as
those in the Export family, is especially critical when faced with a
patient having a heart attack in order to access the lesion quickly and
restore blood flow as soon as possible."
Dr. Jolly serves as a principal investigator of the TOTAL study (a
randomized trial of routine aspiration ThrOmbecTomy with PCI versus PCI
ALone in patients with STEMI undergoing primary PCI), which has an
enrollment target of 6,000 patients across approximately 70 sites
worldwide. Export aspiration catheters are the only devices being used
in the TOTAL study.
A new feature of the Export Advance aspiration catheter is a pre-loaded
stylet, a core wire that runs through the middle of the shaft to provide
more support during delivery. This feature increases the deliverability
and kink resistance of the device when traversing the anatomy to reach
the aspiration site. The Export Advance aspiration catheter is also
constructed with full-wall variable braiding technology that provides
variable levels of stiffness along the length of the device to enhance
flexibility and pushability for optimal catheter performance.
"With more than 10 years of market leadership in this product category,
Medtronic has continued to lead the way in innovation, setting a new
standard of performance with the Export Advance aspiration catheter,"
said Jason Weidman, vice president and general manager of Medtronic's
coronary business. "In addition to superior deliverability, our
next-generation device offers high-performing aspiration power that
physicians have come to expect from Export aspiration catheters, which
to date have been used to treat more than one million patients
worldwide."
Use of aspiration has dramatically increased worldwide since 2008 when
The New England Journal of Medicine published results of a randomized
clinical trial called TAPAS
("Thrombus Aspiration during Percutaneous coronary intervention in Acute
myocardial infarction Study"). Conducted at University Medical Center
Groningen in the Netherlands and involving nearly 1,100 subjects, TAPAS
showed that patients treated with the Export family of aspiration
catheters prior to coronary stenting demonstrated a statistically
significant reduction in cardiac death at one year compared to those who
did not receive aspiration.([1])
TASTE (Thrombus Aspiration in Myocardial Infarction) is a more recent
study of aspiration. Involving approximately 25 sites in Scandanavia
(Denmark, Iceland and Sweden), it randomized more than 7,200 heart
attack patients to receive conventional percutaneous coronary
intervention (PCI) with or without manual aspiration thrombectomy and
has a primary endpoint of time to all-cause mortality at 30 days. Export
aspiration catheters were among the devices used in the TASTE trial,
which Medtronic supported with an unrestricted research grant. Results
from this study will likely be presented later this year.
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.
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