Endocross announced, on 1 October, that it has already enrolled one-third of the patients planned for the first-in-human study of its Enabler-C Catheter System for crossing coronary chronic total occlusions (ENABLER 3C study). The study is taking place at the Institut Cardiovasculaire Paris-Sud under principal investigator Yves Louvard.
The ENABLER 3C study is investigating the safety and performance of the Enabler-C Catheter System in facilitating guidewire advancement through chronic total occlusions in the coronary arteries. Early results are demonstrating significant crossing capability with no adverse effects. The technology is CE-marked and has been used successfully in 22 medical centres around the world for the treatment of chronic total occlusions in the lower limbs, according to Endocross.
“The Enabler technology is designed to assist in the controlled advancement of guidewires through the most challenging arterial lesions. Our chronic total occlusion crossing system is unique in its ability to track the vessel without the need for direct physician navigation of the wire,” said Yaron Eshel, chief operating officer of EndoCross.
“The Enabler is currently the only crossing device that spontaneously adjusts the wire position, thus helping to maintain luminal positioning. 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,” added Eshel. “The Enabler’s progress through the vessel does not require additional imaging or capital equipment. In addition, the system is familiar to the physician as it is based on traditional balloon catheter technologies.”
“Compared to failed chronic total occlusions PCI, successful chronic total occlusions PCI has been associated with improvement in angina, left ventricular function, and increased survival,” said Eshel.
Despite these benefits, chronic total PCI is performed infrequently, most likely due to historically low success rates, technical complexity, and the potential for major procedural complications it states in a company press release.
“The use of the Enabler-C Catheter System may overcome these drawbacks and foster improved patient outcomes,” Eshel adds.