February 9, 2010 Contact: Liz Dowling, (800) 386-0157 Dowling & Dennis Public Relations E-mail: [email protected] Excelsior Medical's New Catheter Lock Solution Approved by Health Canada Replacement for Central Catheter Locking
Clearance of a New Solution as Heparin
February 9, 2010
Contact: Liz Dowling, (800) 386-0157
Dowling & Dennis Public Relations
E-mail: [email protected]
Excelsior Medical's New Catheter Lock Solution Approved by Health Canada
Replacement for Central Catheter Locking
NEPTUNE, N.J. - 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.
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.
About Excelsior Medical Corporation
Excelsior Medical Corporation is one of the leading manufacturers of pre-filled catheter flush syringes. Formed in 1989, Excelsior manufactures, markets and sells pre-filled saline flush syringes, pre-filled heparin flush and lock syringes, and syringe pump systems to customers throughout the world. Excelsior, which also makes the new SwabCap for disinfection and protection of IV access ports, is a privately held company with a primary focus on innovative catheter maintenance products that may reduce infection, medication errors and health care costs.
For more information, call toll-free 800-487-4276 or access www.excelsiormedical.com.
The lock solution should not be used:
Â§ In patients with known allergy or documented hypersensitivity to alcohol, ethanol, sodium citrate, or who have liver disease or history of alcohol abuse;
Â§ For systemic anticoagulant therapy;
Â§ For locking peripheral catheters;
Â§ As a primary treatment for infected catheters.
The lock solution is not intended for:
Â§ Subcutaneous or intramuscular use;
Â§ Use in patients less than 20 kg body weight;
Â§ Use in pregnant women or nursing mothers.
- End -