LifeScan has decided to concentrate on the care of diabetes patients and discontinue its involvement in the field of home INR monitoring. Effective immediately, the HARMONY® INR Meter is no longer available. Patients who currently use the HARMONY System for home INR monitoring will need to switch to a different device in order to continue their home testing regimen.
LifeScan is committed to helping patients make the transition to a new system as convenient as possible. We have partnered with our distributor, Quality Assured Services (QAS), to manage this transition with you. Please read the following information carefully to learn how to receive a replacement monitoring system at no charge.

1. QAS will call both patients and their physicians to discuss the options for a replacement INR monitoring system.

2. Once you and your doctor have selected a replacement system, your doctor will provide QAS with a new prescription. This is important because home INR monitoring systems are available only by prescription.

3. When QAS receives your new prescription, they will deliver your new meter and testing supplies and provide product training with the same level of customer care and service you've come to expect.

4. While you wait for your replacement system, please continue your INR testing as prescribed by your doctor using your current HARMONY Meter and Test Strips. Although the product is being discontinued, there is nothing wrong with the quality of the system or the accuracy of the test results. You should continue to use the system with confidence until you are ready to begin testing with your new meter.

We regret any inconvenience or confusion this issue may cause. If you have any questions please contact your distributor or LifeScan at the following numbers:

QAS-Quality Assured Services
800 915-4515

LifeScan, Inc.
877 520-8608

CHICAGO, March 30 -- LifeScan, Inc., a Johnson & Johnson company, introduced the HARMONY™ INR Monitoring System for weekly home INR testing (International Normalized Ratio, the standard measurement of blood clotting time), here at the 52nd Annual Scientific Session of the American College of Cardiology. The system is designed for the 2.7 million Americans who take the oral anticoagulation medication, warfarin, to prevent life-threatening blood clots and strokes. Studies indicate that blood clots and strokes can be reduced by carefully maintaining the patient's clotting time (reported as INR) within defined boundaries, also referred to as warfarin's therapeutic range. The HARMONY System provides clinical accuracy in a fast, simple, home INR test. Weekly monitoring, with adjustments in medication as necessary, can help increase a patient's time in the therapeutic range and thereby reduce the risk of complications compared to laboratory testing every 4 to 6 weeks.

Warfarin has been used for more than 50 years to help prevent the formation of dangerous blood clots typically associated with a variety of thromboembolic disorders, such as deep vein thrombosis, atrial fibrillation (irregular heartbeat), or in patients with mechanical heart valves or who have experienced a previous stroke. While anticoagulation therapy is highly effective in reducing the risk of stroke resulting from blood clots, this medication must be carefully regulated. Too much warfarin in the body leads to an increased risk of serious bleeding episodes, while too little reduces the drug's effectiveness in reducing clot formation and stroke. Fluctuations can also be caused by factors such as concomitant medications and variations in the patient's diet.

Doctors' concerns that improper warfarin dosing or fluctuations in a patient's INR could lead to a hemorrhage have caused oral anticoagulation therapy to be underutilized in many patients.

"There are a variety of thromboembolic diseases in which oral anticoagulation therapy is extremely beneficial, but many doctors are either reluctant to prescribe warfarin or they keep the dose too low to significantly protect the patient from a stroke," states Alan Jacobson, M.D., F.A.C.C., a cardiologist and director of Anticoagulation Services at the Jerry L. Pettis Veterans Administration Hospital in Loma Linda, California. "With the addition of weekly at-home monitoring, both the effectiveness and safety of anticoagulation therapy can be significantly improved. As a result, doctors will be able to prescribe this medication with far less anxiety."

Most patients on warfarin visit their doctors or a laboratory, on average, every 4 to 6 weeks to have their INR measured and their medication dosages adjusted accordingly. However, the INR can change significantly within a few days due to changes in medication, dietary fluctuations and lifestyle variables. During the interval between tests, if the patient's INR were to drift out of the therapeutic range, it could potentially be undetected, for days or even weeks, thus increasing the risk of a stroke or hemorrhage.
Weekly INR monitoring can help increase the patient's time in the therapeutic range and reduce the risk of complications.* Recently, the Centers for Medicare and Medicaid Services concluded that in order to be in therapeutic range at least 90 percent of the time, a patient most likely needs to be tested weekly.

With the introduction of the HARMONY System, patients or their caregivers can conduct these important INR tests on a weekly basis at home. To perform a test, the patient applies a drop of blood from a fingerstick to a disposable test strip that is read by the portable, HARMONY Monitor. Accurate results are displayed in just 90 seconds. The patient then calls the doctor's office to report the test results as directed. If the INR is out of range, the healthcare professional can make appropriate adjustments to the warfarin dosage.

The HARMONY System is available by prescription only. Medicare provides coverage for weekly home INR monitoring for patients with mechanical heart valves, and a number of private insurers also provide coverage.

LifeScan, a member of the Johnson & Johnson family of companies, is a leading maker of blood glucose monitoring products for people with diabetes. Applying its home diagnostic technology and expertise to the anticoagulation market, the HARMONY System is the company's first product designed to help patients on anticoagulation medication to take an active role in managing their therapy. For more information on LifeScan products and services call LifeScan Customer Services at 877-520-8608.

* Oral anticoagulation therapy and monitoring, regardless of the type, or interval, does not entirely eliminate the risk of stroke or a bleeding episode.

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