Medtronic Receives 'CE' Mark for 'Export Advance' Aspiration Catheter

Mon May 20, 2013 7:00am EDT

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Medtronic, Inc.

Backed by Robust Clinical Data on Broad Product Family,
New Thrombus Removal System Offers Superior Deliverability

MINNEAPOLIS -- May 20, 2013 -- 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 (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.

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.

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[1] Svilaas T., Vlaar P.J., van der Horst I.C., Diercks G. F., de Smet B.J., van den Heuvel A. F., et al.(2008). Thrombus Aspiration during Primary Percurtaneous Coronary Intervention. The New England Journal of Medicine, 358(6), 557-67.

 

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