Healthcare Industry News:  Balloon catheter 

Devices INterventional Cardiology Regulatory

 News Release - September 4, 2014

EndoCross Receives CE Mark Approval for the ENABLER-C Coronary Catheter System for the Crossing of Coronary Chronic Total Occlusions

YOKNEAM, Israel--(Healthcare Sales & Marketing Network)--EndoCross, Ltd., 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.” said Dr. Maurice Buchbinder, M.D., 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 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.

According to a 2010 study completed by the European Society of Cardiology and published in the European Heart Journal, Coronary Artery Disease (CAD) remains as 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% of total cardiovascular disease costs, a total of $23 billion in one year.

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 are currently referred for more costly coronary artery bypass graft surgery rather than treated by PCI. Mr. Eshel concluded, “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”.

About EndoCross

Privately held, EndoCross Ltd. is headquartered in Yokneam, Israel with operations in Amherst, New Hampshire, USA. The ENABLER is a combination of a unique Balloon catheter and a novel automated inflation system. The system empowers physicians to quickly and easily advance angioplasty guidewires beyond arterial blockages, thus avoiding long and complex procedures. It is the expectation of EndoCross management that the ENABLER Catheter System be incorporated into the standard treatment options for PCI, such as angioplasty balloons, atherectomy devices and stents.

Caution:

The ENABLER Catheter Systems are currently not available for sale in the United States.

The ENABLER Peripheral and Coronary Systems are CE Marked and available for use in Europe.

www.endocross.com


Source: EndoCross

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