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The Problem

Intravenous catheterization is one of the most widespread procedures in health care environments. Close to 90% of all hospitalized patients receive intravenous catheters (IVs). According to Netwellness.com, 25 million Americans have intravenous catheters placed each year.

While intravenous catheterization remains one of the most effective ways of administering fluids and medicines to patients, it has two distinct drawbacks:

• It presents a significant risk of infection -- catheter-related bloodstream infections (CRBSIs).

• It requires a complex, high-cost insertion procedure.

IVs are also increasingly used for a number of home health care procedures.

Current Solutions

Current IV catheters are divided into three main types, based primarily on intended duration of use. The first two types are known as “peripheral IVs” as they are placed in the arm, hand, or leg.

• A standard short cannula may be used for up to three days.

• A midline catheter is used for 15 to 30 days.

• A peripherally inserted central catheter (PICC or PIC line or central line) can remain in the vein for 120 days or longer. This is most often placed in the neck (jugular) or just under the collar bone (subclavian).

The overwhelming majority of patients receiving IV therapy require it for periods of 3 to 14 days; yet, up to now, appropriate catheterization methods have been accompanied by problems.

Because of the complicated (and costly) procedure to insert them, midline and central lines are limited in their use, which leads to overutilization of the short cannula. Hospitals have policies dictating how often peripheral IVs should be replaced (usually every three to four days) in order to prevent complications such as phlebitis, cellulitis, and bacteremia.

With the average hospital stay more than three days, large numbers of multiple cannula insertions are required, each time in a different vein. The results —

• additional burden on medical staff resources,

• increased staff exposure to potential needlestick injury,

• greater patient and staff exposure to infection, and

• increased patient discomfort.

Addressing the market need for a simple, safe and quick midterm IV catheter, Flexicath’s FirmGrip system reduces hospital-borne infections and total procedure costs for the 5-14 day IV therapy market.

The Market

The world intravenous catheter tubing market is valued at 1.2 billion units per year (European Plastic News). Flexicath estimates its total available market is approximately 150-200 million procedures per year for mid-term catheterizations (5-14 days) and 2 million per year for PICC line catheterizations.

The central venous catheter (CVC) market is approximately 3 million procedures annually.

In the United States, where the average cost of an infection ranges from $35,000 to $56,000, the annual total for treating these infections is $2.3 billion.

The market needs

• catheters that are simple to insert to fill the much-needed gap of the 5-14 day IV treatment periods, and

• a solution for reducing hospital-borne infections and CRBSIs.