Creative physicians continue to search for new ways to treat vascular disease or disease that can be accessed via the vascular system using infusion catheters. The number of potential procedures and therefore the market for infusion catheters is large.

Market estimates vary but generally suggest that varicose vein disease affects between 75 and 150 million people in North America and Western Europe, making the market for varicose vein disease one of the largest markets for any chronic condition in the developed world.

While the number of people suffering from varicose vein disease is high, only about 1-2% of sufferers actually obtain treatment of any kind. This omission is in large part due to the unsatisfactory characteristics and trauma of existing treatments, including surgery and laser and radiofrequency ablation.




Peripheral Vascular Disease (PVD) affects 5% of all people over 50 years of age. PVD represents a nearly $2 billion market.

Another example is venous thromboembolism, the third most common cardiovascular disease after coronary artery disease and stroke, which has an annual incidence of about 1 per 1000 in the US and is associated with significant morbidity and mortality. Deep vein thrombosis (DVT) is a life-threatening event since a clot can detach, travel to the lung, and occlude a major vessel.

Venous thromboembolism has an annual incidence of 1 per 1000 in the United States. Deep vein thrombosis (DVT) is responsible for up to 600,000 hospitalizations annually with as many as 20,000 patients having had a prior DVT. The majority of patients diagnosed with DVT are treated with medication therapy alone. While this therapy reduces the risk of fatal Pulmonary Embolism and further blood clot from forming, the underlying blood clot may remain and result in permanent vein damage and the development of Post Thrombotic Syndrome.

It has been estimated that venous thrombosis is responsible for between 300,000-600,000 hospitalizations and up to 100,000 deaths annually and the clinical consequences of venous thrombosis such as chronic venous insufficiency with skin ulceration affects up to 500,000 individuals per year. Estimates suggest that 1 out of every 1,000 Americans develops DVT each year; 600,000 new cases are diagnosed each year. One in every 100 people who develops DVT dies.

Catheter-directed treatment of DVT to remove the blockage is a growing treatment option for the disease.

As a third example, an estimated 290,000 people in the U.S. require dialysis access and the number is increasing at a rate of 6% annually. For over 100,000 of patients, dialysis access is obtained through implanted synthetic grafts, which typically require declotting more than once per year, an estimated $37 million annual market in the United States.

There are 472,000 patients receiving treatment for kidney failure in the United States (December 31, 2004); 38.6% of prevalent dialysis patients had an AV fistula; 38.2% AV grafts. A significant number of these patients required a procedure to remove a thrombus from a blocked dialysis access site.

As a fourth example, infusion catheters are used for targeted renal therapy — direct delivery of therapeutic agents to the kidneys via the renal arteries — for patients at high risk of developing acute kidney failure due to their inability to process the contrast agents used during coronary interventional or diagnostic procedures, a condition known as radiocontrast nephropathy (RCN). Infusion catheters are used to dissolve/remove a thrombus from a blocked dialysis access site and for delivering therapeutic agents through the vessel wall into the perivascular space and adventitia.