Medtronic ($MDT) snagged a CE mark for the Export Advance aspiration catheter, planning to launch the clot-removing device in Europe and other international markets.
The catheter is inserted into arteries to clear out clots that interrupt blood flow, restoring oxygen to the heart in patients with cardiovascular disease. The Export Advance comes on the heels of Medtronic's Export AP, and the next-generation model ships with a preloaded stylet that provides more support during delivery and a novel construction that allows for variable levels of stiffness along the length of the device, making it easier to navigate inside the vessel.
"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," coronary General Manager Jason Weidman said in a statement.
The latest Export device is not yet FDA approved, but Medtronic is in the midst of a 6,000-patient study at about 70 sites around the world, testing Export Advance coupled with percutaneous coronary intervention against PCI alone. Sanjit Jolly, a principal investigator in the study, said aspiration treatment is an excellent tool in treating arterial blockage.
"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 said in a statement.
Medtronic plans to tout the device's effectiveness and ease of use at this week's EuroPCR conference in France, where devicemakers from around the globe convene to unveil new data and angle for attention from the continent's interventional cardiovascular specialists.
- read Medtronic's announcement