Most Popular Angioplasty Web Site
Stent Center Stent Center
with support from Medtronic Cardiovascular
Medtronic Gains European Approval for New Thrombus Removal System
Share This Story:
Bookmark and Share

related stories on

Drug-Eluting Stent Center

All Medtronic
Press Releases

Medtronic's Export Advance aspiration catheter
Medtronic's Export Advance aspiration catheter
May 23, 2013 -- This week Medtronic, Inc. (NYSE: MDT) announced that the most recent addition to its portfolio of aspiration catheters, the Export Advance, has received the CE Mark and will soon be launched in Europe and other markets.

To date, over one million patients have been treated using Export aspiration catheters. The new Export Advance features a stylet, pre-loaded with a core wire that runs through the middle of the shaft to provide more support during delivery to increase deliverability and kink resistance. The Export Advance also incorporates what the company calls "full-wall variable braiding technology," which provides variable levels of stiffness along the length of the device to enhance flexibility and pushability for optimal catheter performance.

Background of Aspiration for STEMI
For many years primary PCI (angioplasty and stents) has been the gold standard for the treatment of heart attack, specifically ST-segment elevation myocardial infarction (STEMI).

A STEMI occurs when a blood clot, or thrombus, forms in the coronary artery and occludes blood flow, preventing oxygen from reaching the heart muscle. If flow is not restored quickly, the heart muscle can suffer permanent damage.

Thrombus usually forms in an area of the artery that already has some type of physical obstruction but where, for some reason, the plaque has erupted and platelets begin to collect and form a clot. Unlike the harder plaque which can be compressed against the arterial wall by a balloon and stent, the thrombus is "spongy" and is not easily eliminated.

Enter the "vacuum cleaner," or aspiration catheter. As seen in the New England Journal of Medicine video below, an aspiration catheter can be advanced over a guide wire to the infarct location and literally vacuum up the blood clot, eliminating the thrombus. Over the same guide wire, a balloon and stent can then be placed, opening up the artery and restoring full blood flow to the heart.

This educational video from the New England Journal of
Medicine shows how a generic thrombus aspiration is
performed in the setting of Acute Myocardial Infarction

Speed is of the essence when treating a STEMI because every second counts in trying to keep the heart muscle from being damaged.

Interventional procedures have been credited with successfully revolutionizing the treatment of heart attacks. In the pre-angioplasty era myocardial infarctions had a 30% or greater mortality rate. Today less than 5% of heart attacks are fatal.

The technique of thrombus aspiration gained significant credibility after the publication of the TAPAS study in 2008 which showed a mortality benefit for patients when thrombus aspiration was utilized during a primary PCI. That landmark study was done with the Export family of aspiration catheters, manufactured by Medtronic.

The Export Advance is the latest device in that product family. Although now approved for sale in the European market, the Export Advance is not yet approved for use in the United States.

A press release from Medtronic, Inc. with more information about the Export Advance follows:

Medtronic Receives 'CE' Mark for 'Export Advance' Aspiration Catheter
Backed by Robust Clinical Data on Broad Product Family, New Thrombus Removal System Offers Superior Deliverability

May 20, 2013 -- Minneapolis -- Expanding its portfolio of medical technology for the interventional treatment of cardiovascular disease, Medtronic, Inc. (NYSE: MDT) announced today that the Export Advance aspiration catheter recently received the CE (Conformite Europeenne) 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.

Sanjit Jolly, MD
Sanjit Jolly, MD

"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 Scandinavia (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.

About Medtronic
Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology -- alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Reported by Burt Cohen, May 23, 2013