European Regulators Approve EndoCross Enabler-C System

EndoCross Ltd. has won European CE Mark approval for its Enabler-C Coronary Catheter System used to cross chronic total occlusions.

The Enabler technology allows standard guidewires to be used to cross lesions by positioning a balloon before the occlusion that holds onto the vessel wall. A guidewire that can move through the balloon is repeatedly pushed forward, each time advancing a bit further. The balloon helps the guidewire stay straight and deliver the necessary pressure to the lesion needed to cross it.

“EndoCross has developed a chronic occlusion crossing device that can facilitate penetration and crossing of complex occlusions with standard off-the-shelf wires. The device allows for controlled luminal crossing.” said Maurice Buchbinder, M.D., chief medical 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 (CAD) is the leading cause of death in both the European Union and globally. CAD is a major cause of morbidity and loss of quality of life. The disease generated 27 percent of total cardiovascular disease costs, a total of $23 billion in one year.

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 BTK solutions, provides physicians with the tools they need to make the crossing of CTOs a more straight forward, consistent, and successful procedure,” said Yaron Eshel, chief operating officer of EndoCross.

Significant improvements in acute and long-term results drive an ongoing interest in the percutaneous coronary intervention (PCI) treatment of CTOs. However, due to the complexity of existing solutions and a persistent degree of outcome uncertainty, many patients with CTOs currently are referred for more costly coronary artery bypass graft surgery rather than treated by PCI.

“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 CTOs, resulting in improved patient treatment and lower overall cost,” Eshel added

Privately held, EndoCross Ltd. is headquartered in Yokneam, Israel, with operations in Amherst, N.H.