Israel-based medical devices developer EndoCross has revealed that its Enabler-C catheter system has demonstrated ‘significant capability’ for crossing coronary chronic total occlusions (CTO) with zero adverse effects in the first-in-human study.
The company has already enrolled one third of patients planned for the study.
The Enabler 3C clinical study is being conducted under principal investigator Dr Yves Louvard. It is designed to evaluate the safety and performance of the Enabler-C catheter system in facilitating guidewire advancement through CTO in the coronary arteries.
According to the company, early results show significant crossing capability with no adverse effects.
Using traditional balloon technologies, EndoCross has developed a unique balloon designed to provide guidewire support, centralisation, and controlled advancement.
The Enabler crossing catheter system is simple to set-up and use and requires no capital equipment to operate.
Enabler technology is designed to assist in the controlled advancement of guidewires through the most challenging arterial lesions.
EndoCross COO Yaron Eshel said the company’s CTO crossing system is unique in its ability to track the vessel without the need for direct physician navigation of the wire.
"The Enabler is currently the only crossing device that spontaneously adjusts the wire position, thus helping to maintain luminal positioning," Eshel said.
"While other companies have focused on providing additional energy to the tip of the wire, the Enabler uses cyclical and controlled incremental advancements to guide the wire through the totally occluded vessels."
The same technology, which already obtained CE-mark, is being used successfully in 22 medical centres around the world for the treatment of CTO in the lower limbs.
The Enabler-C Catheter system is expected to overcome the drawbacks of the current treatment of arterial lesions and deliver better patient outcomes.
EndoCross chief medical officer Dr Maurice Buchbinder said: "The device allows for effective and controlled luminal crossing".
The Enabler-C is currently under investigation at the Institut Cardiovasculaire Paris Sud, Massy, France.
According to GlobalData estimates, the cardiac catheters market in the US was valued at $387m in 2012 and is expected to grow at a CAGR of 3% to reach $476m by 2019.