Embolic Protection for Coronary Applications

The system has received the CE Mark.

The system is deployed in a proximal segment of the target vessel, upstream of the blockage. This way, there is no need to cross the blockage without first protecting the vessel. The system briefly occludes the target vessel, stagnating blood flow. Embolic debris created during stent deployment becomes suspended in the vessel and is then evacuated by reversing the flow with a syringe. Results of a clinical trial involving 35 patients treated with the system showed a very low major adverse cardiac event (MACE) rate of 5.7% (two of 35 patients). The events were not directly related to the device, however, so the adjusted rate is 0%.

Called Proxis, the system was developed by Velocimed Inc. (Minneapolis, MN, USA). The company states that distal occlusion systems, as opposed to its proximal system, are difficult to use and may not completely protect a patient from embolic events because they must initially cross the blockage without protection.

"I look forward to using the Proxis System because I believe it provides the highest level of embolic protection,” said Prof. Horst Sievert, of the Cardiovascular Center Bethanien in Frankfurt (Germany), the principal investigator of the trial. "The Proxis is able to remove all embolic debris, including small particles, which may be important in reducing MACE events.”




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Velocimed