Medtronic's Export Advance Aspiration Catheter Receives CE Mark Approval for Thrombus Removal

May 20, 2013—Medtronic, Inc. (Minneapolis, MN) announced that the company's Export Advance aspiration catheter, a thrombus removal system, has received CE Mark approval and will soon be launched in Europe and other international markets. The Export Advance device is not approved for use in the United States.

In its press release, Medtronic noted that a new feature of the Export Advance aspiration catheter is a preloaded 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.

“When thrombus completely or partially blocks an artery, aspiration is an important first step of the treatment process that can improve clinical outcomes,” commented Sanjit Jolly, MD. “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, who is an Associate Professor of Cardiology at McMaster University in Hamilton, Ontario, and an interventional cardiologist at Hamilton Health Sciences, serves as a Principal Investigator of the TOTAL study, which is a randomized trial of routine aspiration thrombectomy with percutaneous coronary intervention (PCI) versus PCI alone in patients with ST-segment elevation myocardial infarction (MI) undergoing primary PCI. The TOTAL study has an enrollment target of 6,000 patients at approximately 70 sites worldwide. Medtronic's Export aspiration catheters are the only devices being used in the TOTAL study, which is sponsored by the Population Health Research Institute of Hamilton Health Sciences/McMaster University.

Medtronic noted that use of aspiration has dramatically increased worldwide since 2008, when results of the randomized clinical TAPAS trial of thrombus aspiration during PCI in acute MI were published by Tone Svilaas, MD, et al in The New England Journal of Medicine (2008;358;557–567). The study was conducted at University Medical Center Groningen in The Netherlands and involved approximately 1,100 patients. In TAPAS, patients treated with the Export family of aspiration catheters before coronary stenting demonstrated a statistically significant reduction in cardiac death at 1 year compared to those who did not receive aspiration.

More recently, the TASTE trial of thrombus aspiration in MI randomized more than 7,200 MI patients to receive PCI with or without manual aspiration thrombectomy. The study involved approximately 25 sites in Denmark, Iceland, and Sweden. TASTE 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, advised the company.