CE mark approval for Enabler-C coronary catheter system

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EndoCross has received CE mark approval for the Enabler-C coronary catheter system. The Enabler-C features a unique controlled guidewire advancement technology currently available in the CE marked Enabler-P peripheral catheter systems. The CE mark of the Enabler-C coronary catheter system follows the successful first-in-man study of the Enabler-C that took place at the Institut Cardiovasculaire Paris-Sud.

“EndoCross has developed a unique chronic occlusion crossing device that can facilitate penetration and crossing of complex occlusions with standard off-the-shelf wires. The device allows for effective and controlled luminal crossing,” says Maurice Buchbinder, chief medical officer of EndoCross.

 


The Enabler technology makes use of a propriety balloon design that allows for continuous and controlled luminal guidewire advancement through coronary chronic total occlusions (CTOs). “The addition of the coronary catheter system, together with our existing peripheral femoropopliteal and below-the-knee solutions, provides physicians with the tools they need to make the crossing of chronic total occlusions a more straight forward, consistent, and successful procedure,” says Yaron Eshel, chief operating officer of EndoCross.

 


According to a 2010 study completed by the European Society of Cardiology and published in the European Heart Journal, coronary artery disease remains as the leading cause of death in both the European Union and globally. Coronary artery disease is a major cause of morbidity and loss of quality of life.

Significant improvements in acute and long-term results drive an ongoing interest in the percutaneous coronary intervention (PCI) treatment of chronic total occlusions. However, due to the complexity of existing solutions and a persistent degree of outcome uncertainty, many patients with chronic total occlusions are currently referred for more costly coronary artery bypass graft surgery rather than treated by percutaneous coronary interventions. Eshel concludes, “The Enabler-C catheter system uses familiar balloon catheter and guidewire technologies and does not require expensive or complex capital equipment. Therefore, the system may provide the simplicity and consistency needed to increase the overall rate of PCI treatment of chronic total occlusions, resulting in improved patient treatment and lower overall cost.”

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