Excelsior Medical receives Canadian marketing license for new, pre-filled catheter lock syringe

Feb 10 2010

Excelsior Medical Corporation, one of the leading manufacturers of pre-filled catheter flush syringes, today announced that it has received a Medical Device License from Health Canada for its new, pre-filled catheter lock syringe to be sold in the Canadian marketplace.

“This new Excelsior Medical product has been in development for over three years, and included detailed studies on patency and catheter compatibility. We’ve also redesigned the syringe and plunger to maintain stability of the solution and a 2 year expiration date.”

The syringe contains the first commercially available heparin replacement solution – a combination of 4% Sodium Citrate and 30% Ethanol in water for injection. The solution has similar anticoagulant properties to heparin so it helps maintain catheter patency without the possible negative side affects.

The new Excelsior Medical solution has a major advantage over heparin, because it eliminates many of the potentially dangerous complications associated with heparin. Heparin in low concentrations has been the traditional locking solution for central venous catheters. But heparin use entails risks such as the potential for bleeding disorders, hemorrhaging due to an overdose, heparin induced thrombocytopenia, and the chances of being mixed with incompatible medications.

“There has long been a need for an affordable replacement for heparin locking solution that is broadly available commercially,” said Bill Rice, Excelsior’s President and CEO. “This new Excelsior Medical product has been in development for over three years, and included detailed studies on patency and catheter compatibility. We’ve also redesigned the syringe and plunger to maintain stability of the solution and a 2 year expiration date.”

Until now, there have been no commercial products containing the 4% Sodium Citrate/30% Ethanol solution. Hospitals have had to request that small batches of the solution be prepared by their pharmacy by using a very labor intensive process.

Health Canada is the department of the Canadian federal government responsible for public health, including the regulation of drugs and other health products. The license it issued to Excelsior permits the product to be sold in the Canadian marketplace. The product is not approved for sale in the United States.