Drug-eluting coronary stents involve the placement of the drug on the stent, with the drug then gradually being absorbed – currently one of the most common, and profitable, applications of a drug/device combination.

Cook (Bloomington, Indiana) has a somewhat different approach in this combination, impregnating the drug within a device – only in this case for preventing the much-feared infection involved with the use of central venous catheters. And the company has combined this with a multi-lumen approach to avoid the multiple ways in which the use of catheters may lead to serious and serious catheter-related bloodstream infections (CRBSI).

The company has just announced roll-out of its new five-lumen, drug-impregnated central venous catheter, the next-generation Spectrum, designed both to improve multiple treatment administration and to provide increased protection against hospital-based CRBSI. The device received FDA 510(k) clearance in February.

This latest version of the Spectrum incorporates five non-communicating vascular access lumens within a single catheter body to reduce the necessity of performing multiple venipunctures or multiple stopcock configurations using single-lumen catheters, Tom Saccone, product manager for critical care for Cook, told Medical Device Daily.

Saccone notes that traditional catheters provide multiple pathways for infection – the main four being migration from the patient's skin; contamination by care providers manipulating the catheter; hematogeous seeking, meaning migration from another infection site in the patient; and infection from a saline drip bag.

All of these possibilities are then multiplied with each puncture for a new catheter for administration of different medications, blood sampling and monitoring or a variety of other treatments and procedures; or with “piggy-backing” of catheters offering the possibility of mixing fluids in communicating channels.

These possibilities are much reduced, Saccone said, with the multi-lumen approach, thus avoiding multiple insertions, piggy-backing or the need for manipulating multiple stop-cocks.

This approach is then further “fail-safed” with Cook's drug-impregnation process. “It's a proprietary process,” he says, “to bond the drugs to the catheter and do it in such a way that it maintains its efficacy over the life of the product, inhibiting bacteria, colony-forming units on these devices.”

Saccone acknowledges the higher price tag of the new Spectrum device but the possibility of greatly reducing CRBSIs.

He points to studies by the Center for Disease Control and Prevention (CDC; Atlanta), putting the cost of treating these infections at $35,000 to $50,000 per patient and the roughly 5 million placements of these catheters annually – and wrose, up to 28,000 deaths annually from catheter-based infections

Saccone notes that in 2002 the CDC established guidelines for prevention of intravascular, catheter-related infections, including attempting to reduce the number of catheters used and the need for anti-infectants with these catheters.

Thus, he says that the development of the advanced Spectrum catheter is “a real big step for us as far as the synergies between CDC and our technology. This is meaningful for us on a financial perspective but also in terms of saving patient lives.”