EndoCross Reports Early Success with First-in-Human Study of Its ENABLER-C Catheter System
EndoCross, Ltd., which has developed a simple and cost-effective method for crossing the most challenging lesions in the percutaneous treatment of blocked coronary arteries, announced today 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 ENABLER 3C clinical study is taking place at the Institut Cardiovasculaire Paris-Sud under principal investigator Dr. 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. It is important to note that the same technology is already CE-marked and has been used successfully in 22 medical centers around the world for the treatment of CTO in the lower limbs.
“The ENABLER technology is designed to assist in the controlled advancement of guidewires through the most challenging arterial lesions. Our CTO 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 Mr. 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.” “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,” added Maurice Buchbinder, M.D., Chief Medical Officer for EndoCross. Dr. Buchbinder has pioneered numerous medical devices used worldwide for the treatment of cardiovascular disease. He is considered a thought leader in the field of interventional medicine worldwide.
“Compared to failed CTO PCI, successful CTO PCI has been associated with improvement in angina, left ventricular function, and increased survival,” said Mr. Eshel. Despite these benefits, CTO PCI is performed infrequently, most likely due to historically low success rates, technical complexity, and the potential for major procedural complications (1). “The use of the ENABLER-C Catheter System may overcome these drawbacks and foster improved patient outcomes,” he added.
(SUMMARY: Chronic total occlusion (CTO) of the coronary arteries is commonly referred to as the ‘last frontier’ of percutaneous cardiologic intervention (PCI). Over 30% of PCI procedures aimed at the recanalization of CTO fail (1), with the major cause being the inability of the guidewire to cross the target lesion (2). The ENABLER-C Catheter system is designed to offer a new solution for the treatment of these challenging lesions.) About Coronary Arterial Disease (CAD) Coronary arterial disease (CAD) is defined as an obstruction of blood flow into the coronary arteries that supply oxygen and nutrients to the myocardium (the muscle of the heart). CAD is a major cause of death and disability in developed countries and is responsible for about one-third of all deaths in individuals over age 35 (3,4). Treatment of CAD can involve the use of medication and risk reduction by change of life-style, percutaneous coronary interventions (PCI) and coronary arterial bypass graft surgery (CABG).
1 Patel VG, Brayton KM, Tamayo A, et al. Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv. 2013 Feb;6(2):128-36. doi: 10.1016/j.jcin.2012.10.011. Epub 2013 Jan 23
2 Yoshihiro Morino, Takeshi Kimura, Yasuhiko Hayashi, et al, In-Hospital Outcomes of Contemporary Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion, Insights From the J-CTO Registry (Multicenter CTO Registry in Japan), JACC Cardiovasc Interv. 2010 Feb;3(2):143-51
3 Rosamond W, Flegal K, Furie K, et al; Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2008;117(4):e25
4 Lloyd-Jones D, Adams RJ, Brown TM, et al; Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation 2010;121(7):948