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Robbin George
New Catheter Lock Solution

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

 Clearance of a New Solution as Heparin

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





The lock solution should not be used:

§   In patients with known allergy or documented hypersensitivity to alcohol, ethanol, sodium citrate, or who have liver disease or history of alcohol abuse;

§   For systemic anticoagulant therapy;

§   For locking peripheral catheters;

§  As a primary treatment for infected catheters.




The lock solution is not intended for:

§  Subcutaneous or intramuscular use;

§  Use in patients less than 20 kg body weight;

§  Use in pregnant women or nursing mothers.


- End -

Gwen Irwin
New Catheter Lock Solution

What prevents it from being available in the US?  FDA approval for use pending?

We will have to see the impact on the Canadian patients to determine its efficacy, right?

Gwen Irwin

Austin, Texas

The FDA clearance process is

The FDA clearance process is what is keeping the US from having access to this and other alternative locking solutions. These products would come to the US market as a combination product - combining the solution and the syringe, a drug and a device. This requires a combined effort from the Centers for Drug Evaluation and Research and the Centers for Devices and Radiologic Health, 2 of the 6 FDA centers. I have no idea when we will see these alternative lock solutions available in the US. Lynn

Lynn Hadaway, M.Ed., RN, BC, CRNI

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257


Office Phone 770-358-7861

sodium Citrate

Approximately 5-10 years ago there was a link between high doses of sodium citrate and dialysis patient deaths in the United States.  The dosage was way higher than 4%.  Dialysis catheters were being locked at the time with sodium citratre. 

Here are the quesions I have:

  1. If a flush is given 8 to 10 times a day in a patient what is the cummulative effect of the dosage on the patient?
  2. What is the effect of the solution on the plastic of the catheter if it is locked?
  3. Are you supposed to pull this flush out of the catheter before use?  Will staff even do that?

Using this product in the United States would constitute off label use.  I would want to see testing for any flush solution for patient safety. I would err on safety after the issues in the dialysis population.

I am not sure we even need an alternative to heparin unless it reduces catheter infections and even than it will only work on intraluminal catheter infections.  Today we are eliminating heparin with other methods.  The long term systemic effects of a flush solution need to be highly studied as we have seen the black box warning with the industry standard of heparin and HIT risk.

Kathy Kokotis RN BS MBA

Bard Access Systems

Kathy, you and I will have to

Kathy, you and I will have to agree to disagree on your statement about eliminating heparin by other means. I have recently examined all available literature on this issue and the plain fact is that the outcomes are mixed. Some purport better outcomes with saline only however the study design and power is not sufficient to make that generalized statement. There are other studies that strongly support that saline only locking produces greater risk of lumen occlusion and thrombosis. All you have to do is talk with a nurse in a hospital that is using saline only locking for CVC and most will tell you that their use of tPA for lumen clearance has greatly increased, but this is anecdotal information. So I do think we need alternative locking solutions because I firmly think that saline alone is not sufficient. Lynn

Lynn Hadaway, M.Ed., RN, BC, CRNI

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257


Office Phone 770-358-7861

Daphne Broadhurst
We've been using ethanol with

We've been using ethanol with success in some of our HPN clients and citrate 4% for all of our dialysis clients. Can't wait for it to get to market and see the outcomes of a product that combines the two, killing the bugs and keeping the lines patent.

Daphne Broadhurst RN
Desjardins Pharmacy
Ottawa ON

Daphne Broadhurst
Desjardins Pharmacy
Ottawa, Canada

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