Kensey Nash Receives FDA 510(k) Clearance for New Safe-Cross(R) Vessel Wall Detection ...(he CTO Market Chronic Total Occlusion...)

Chronic Total Occlusions are described as the "last frontier" of interventional cardiology and represent a large market opportunity in both coronary and peripheral markets. It is estimated that 30-50% of people diagnosed with coronary artery disease have at least one CTO, yet patients are rarely treated due to challenging nature of the cases and the inability to cross the CTO with conventional guidewire techniques. Often patients are not treated at all, or are referred for coronary bypass surgeries. Successful interventions of coronary CTOs have been associated with increased survival rates, decreased rates of coronary bypass surgery, and enhanced quality of life.

Peripheral Vascular Disease (PVD) is a large and rapidly growing market affecting well over 9 million people in the United States. There are approximately 2.5 million patients in the U.S. diagnosed annually with lower extremity PVD, which includes atherosclerosis of the SFA, popliteal, and distal arteries below the knee. As lower extremity PVD worsens, Critical Limb Ischemia (CLI) can develop, significantly increasing a patient's risk for amputation and limb loss. An estimated 1.5 - 2 million patients suffer from CLI, and each year, of which approximately 330,000 patients with lower limb PVD are referred to surgery, either for an invasive bypass procedure (170,000) or for amputation (160,000). More broadly, clinicians estimate that 50% of all peripheral lesions, or 1.25 million lower extremity PVD patients, have CTOs, and there is a broad consensus among interventionalists that existing tools are inadequate and that better solutions are required.

About Kensey Nash Corporation

Kensey Nash Corporation is a leading medical technology company providing innovative solutions and technologies for a wide range of medical procedures. The Company provides an extensive range of products into multiple medical markets, primarily in the endovascular, sports medicine and spine ma
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