CE mark approval for Metronic’s Export Advance aspiration catheter

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According to Medtronic, the Export Advance aspiration catheter has received the CE mark. The Export Advance aspiration catheter is not approved for use in the USA. The latest addition to the Export family of aspiration catheters are expected to be exhibited at EuroPCR (May 21–24, Paris, France).

“When thrombus completely or partially blocks an artery, aspiration is an important first step of the treatment process that can improve clinical outcomes,” said Sanjit Jolly, an associate professor of cardiology at McMaster University in Hamilton, Canada, 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.”

Jolly is also principal investigator of the TOTAL study (A randomised trial of routine aspiration thrombectomy with PCI versus PCI alone in patients with STEMI undergoing primary PCI), which has an enrolment target of 6,000 patients across approximately 70 sites worldwide.

According to the company, 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 is said to increase 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, according to the company release.

Jason Weidman, vice president and general manager of Medtronic’s coronary business said: “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.”

According to the release, the use of aspiration has dramatically increased worldwide since 2008 when The New England Journal of Medicine published results of a randomised 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.

TASTE (Thrombus aspiration in myocardial infarction) is a more recent study of aspiration. Involving approximately 25 sites in Scandanavia (Denmark, Iceland and Sweden), it has randomised 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. Medtronic, in the press release stated that the results from this study are likely to be presented later this year.

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