Medical device industry titan Medtronic (NYSE:MDT) announced today that it won CE Mark approval in the European Union for its latest thrombus removal system, the Export Advance aspiration catheter.
The new device, the latest in the Export family, will hit the shelves "soon" in Europe and other international markets, Medtronic reported.
Medtronic’s Export aspiration catheter line is the "market leader in aspiration with over 1 million patients treated to date," a company spokeswoman told MassDevice.com in an emailed statement.
The new Export Advance features a pre-loaded stylet, a wire that runs through the center of the catheter shaft to support the device and prevent kinking, as well as new braiding technology that allows variable stiffness and flexibility, according to a press release.
Medtronic’s next-generation Export Advance is the subject of the randomized TOTAL clinical trial evaluating the device as an adjunct to percutaneous coronary intervention, compared with PCI alone. That study aims to enroll 6,000 patients from 70 clinical sites worldwide.
"When thrombus completely or partially blocks an artery, aspiration is an important first step of the treatment process that can improve clinical outcomes," principal trial investigator Dr. Sanjit Jolly said in prepared remarks. "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."
