SALT LAKE CITY–(BUSINESS WIRE)–XableCath, a commercial-stage medical device company, announced today that it has demonstrated initial safety and efficacy of its unique catheters for use with chronic venous occlusions, commonly characterized by recalcitrant lesions that have historically proven difficult to cross with standard catheter technologies. XableCath catheters are FDA-cleared for use in the peripheral vasculature and may be used in both peripheral arteries and veins.
The unique design of both the blunt- and abrasion-tip XableCath catheters — with their excellent columnar support and pushability — crossed tough venous lesions quickly and with relative ease, even in cases where other products could not. Failure rates in crossing venous occlusions have historically been high due to inadequacies in currently available technologies. Also, crossing devices used in arterial lesions have not been validated in the venous system for lesions that are pathologically different: dense fibrous collagen versus atherosclerotic, often calcified, plaque. Safe and effective crossing is necessary to facilitate angioplasty or stenting that can relieve the venous hypertension and improve the functional status of the limb.
More prevalent than peripheral artery disease, chronic venous insufficiency (CVI) afflicts more than 30 million patients in the United States alone. Left untreated, patients with CVI suffer from debilitating eczema, lipodermatosclerosis, pain and venous ulcers. While endovascular treatments exist in the form of drug-coated balloons and stents, interventionalists are often unable to administer these treatments due to a lack of reliable options to cross occlusions. With several new products available and many more in clinical trials for use in the venous vasculature system, interventionalists are shifting their practice to the treatment of CVI, resulting in a burgeoning need for a safe and effective crossing solution.
“The clinical results of our first small series of venous use cases are outstanding, and we are delighted with the early results showing the unique ability of our catheters to successfully and safely cross venous occlusions,” said Lisa Dunlea, XableCath’s President and CEO. “This is a great market opportunity for XableCath, because few solutions exist for safe and effective crossing of challenging venous lesions. Physicians have long voiced their demand for such a product, and we look forward to continuing to address their needs, helping to improve patient care and empowering interventionalists to tackle more difficult cases.”
Patricia Thorpe, MD, an interventional radiology specialist at St. Luke’s Medical Center in Phoenix, AZ was the first in the world to use the XableCath blunt-tip catheter in a venous case, which was also the first use of XableCath technology in the venous system. “The XableCath blunt-tip catheter provided excellent support for crossing chronic femoral iliac and caval thrombus as the catheter resists buckling and allows a twisting technique to advance over an .018″ or .035″ wire,” said Dr. Thorpe. “An advantage is that the lumen is designed to use with either size wire. This eliminates need to exchange catheters.”
Ramsey A. Al-Hakim, MD, Assistant Professor & Director of Inpatient Services at Oregon Health & Science University, was the first in the world to use the XableCath abrasion-tip catheter in a venous case. “When my conventional crossing catheters failed, I was able to successfully cross an iliac chronic total occlusion using the abrasion tip catheter and complete the iliocaval reconstruction to help my patient with a non-healing venous ulcer,” said Dr. Al-Hakim.
As a next step, XableCath plans to complete a venous registry study in the United States.
XableCath was founded in 2014 to commercialize catheters for the treatment of vascular disease. XableCath technology is revolutionary and allows effective treatment, improving the lives of patients and transforming the ease of vascular interventions for physicians. For more information visit www.xablecath.com.
President and CEO