October 21, 2013 -- Today Medtronic, Inc. (NYSE: MDT) announced the product launch of its latest thrombus aspiration catheter, the Export Advance, which recently received a 510k clearance from the U.S. Food and Drug Administration. The Export Advance received the CE Mark this past May.
Over one million patients have been treated using Export aspiration catheters. This latest model 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.
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
Enter the "vacuum cleaner," or aspiration catheter. As seen in this New England Journal of Medicine video, 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.
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.
These improved outcomes seen when thrombus aspiration was utilized were recently sustained in a new meta-analysis, appearing the the October 15 issue of the Journal of the American College of Cardiology, titled "Role of Aspiration and Mechanical Thrombectomy in Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty." The authors concluded that, "Thrombectomy during AMI by manual catheter aspiration...is beneficial in reducing MACE, including mortality, at 6 to 12 months compared with conventional PCI alone."
This morning's press release from Medtronic, Inc. follows:
Medtronic Launches New Device To Remove Coronary Thrombus Long-Time Market Leader Introduces U.S. Cardiologists to Greater Power and Superior Deliverability of Next-Generation 'Export Advance' Aspiration Catheter
October 21, 2013 -- Minneapolis -- With more than a decade of market leadership in medical devices designed to remove thrombus from coronary arteries, Medtronic, Inc. (NYSE: MDT) announced today the U.S. launch of the Export Advance aspiration catheter, which offers greater power and superior deliverability.
Recently cleared by the U.S. Food and Drug Administration (FDA), the latest addition to Medtronic's portfolio of thrombectomy devices features 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 new device while traversing the vasculature to reach the aspiration site.
To further optimize performance, the Export Advance aspiration catheter is also constructed with full-wall variable braiding technology, which provides variable degrees of stiffness along the length of the device to enhance flexibility and pushability while navigating the device through the vasculature.
"With the Export Advance aspiration catheter, Medtronic has taken the power and deliverability of manual thrombectomy devices to a new level," said Dr. Hoang Thai, an associate professor of medicine and associate program director of the interventional cardiology fellowship at the University of Arizona.
The Export Advance aspiration catheter received the CE (Conformité Européenne) mark in May and has been introduced in various international markets since then. It is the latest addition to Medtronic's portfolio of thrombectomy devices, which also includes the market-leading Export AP aspiration catheter.
"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."
In collaboration with leading clinicians, researchers and scientists, 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 worldwide.
About Medtronic
Medtronic, Inc. (www.medtronic.com), 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.
