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

Milpitas, Calif. September 5, 2001-A new anticoagulation blood monitoring system that could help the 2.5 million U.S. patients on the blood-thinning medication warfarin better keep their blood coagulation time in a safe or "therapeutic" range has been cleared by the U.S. Food & Drug Administration. LifeScan, Inc., a Johnson & Johnson company, announced the product clearance today for it's new Harmony™ INR Monitoring System, which uses a simple test procedure to provide clinically accurate measurements of the rate at which a warfarin patient's blood coagulates. This coagulation rate is known as a patient's prothrombin time (PT) and is numerically reported by the Harmony™ System as an International Normalized Ratio (INR), a standardized and accepted method for reporting PT results. The patented Harmony System is designed to be used by patients for self-testing their PT at home or by healthcare professionals to test patients in their medical offices.

The new system is expected to be available for purchase next year to healthcare professionals and by prescription to patients that have completed a training program on the use of the device.

It's important for a patient's PT/INR to stay in the recommended therapeutic range, as established by the American College of Chest Physicians. This means, in essence, that the patient's blood is clotting at a rate that is neither too slow nor too fast. If a patient's PT/INR strays outside of this range-even for a short period-it can lead to serious, acute health consequences, including internal bleeding (i.e., hemorrhage and/or hemorrhagic stroke) or clotting (i.e., thromboembolism and/or stroke).

"This new monitoring system will help a lot of warfarin patients in their efforts to keep their prothrombin time within a safe and healthy range," said Alan Jacobson, M.D., a cardiologist with the Veterans Administration Medical Center in Loma Linda, Calif., and a clinical investigator for the multi-site trial that tested the LifeScan system. "The LifeScan INR monitoring system also helps simplify self-testing by eliminating the need for separate quality control tests. These controls have been integrated into the test strip, making training on the use of the device easier for the patients and providing an added level of confidence in the device's reporting of test results."

Using the new system from LifeScan is similar in concept and testing technique to the use of blood glucose monitors, which are used by millions of people with diabetes to self-test blood glucose levels. The Harmony INR Monitoring System consists of a handheld electronic monitor and disposable, single-use test strips that have automatic, built-in-also referred to as "on-board"-quality controls (QC). In addition to making PT testing simpler and more convenient by eliminating separate QC tests, the automatic, on-board QCs also help monitor the proper functioning of each PT test. In fact, if the QCs don't pass during a given PT/INR test, the Harmony System will not display an INR result, thereby preventing a patient from receiving a result that may be in question.

PT Self-Testing for Patients on Warfarin; Testing with the Harmony System
The ability to self-test at home should enable many warfarin patients to increase the frequency of their PT/INR testing to as often as once a week. Some clinical studies have suggested that testing at least once a week can benefit patients by helping them-under the direction of their physician-appropriately adjust their warfarin dosages, and as a result, increase the amount of time that they stay in therapeutic range.

Traditionally, most warfarin patients have not self-tested their PT/INR but, instead, have visited their physician's office or a medical laboratory to have a PT test administered. With that result in hand, the physician can then make decisions regarding the patient's warfarin dose so that the patient's blood will clot within a targeted range of time. However, the duration of action of a single dose of warfarin is only 2 to 5 days, while a patient's PT-when tested in the laboratory or medical office-is typically monitored only once every four to six weeks. Such infrequent testing may delay warfarin dosage adjustments and allow the patient's INR to unnecessarily stray outside of their target therapeutic range, which can lead to the serious, acute complications of internal bleeding or clotting.

Therefore, because self-testing should better enable appropriate adjustments in warfarin dosages, the Harmony INR Monitoring System is expected to be viewed as welcome news by many healthcare professionals and patients, as it is estimated that only a small fraction of the 2.5 million warfarin patients in the U.S. are currently involved in any kind of self-testing program.

To perform a test with the Harmony INR Monitoring System, a user inserts a single test strip into the monitor and then applies a 20-microliter blood sample-obtained from the fingertip-onto the test strip. In less than 2 minutes, the monitor measures the PT time, calculates the result and displays it in INR units.

Marketing Alliance with St. Jude Medical
LifeScan and St. Jude Medical, Inc. (NYSE:STJ) have entered into an exclusive U.S. marketing agreement to promote the Harmony INR Monitoring System to healthcare professionals caring for patients with mechanical heart valves, all of whom require warfarin therapy. St. Jude Medical, based in St. Paul, MN, is the world's leading manufacturer of mechanical heart valves. (A separate press release on the LifeScan/St. Jude Medical co-marketing agreement is available from Business Wire.)

Founded in 1981, LifeScan is a leading maker of blood glucose monitoring systems for people with diabetes. Every day, more than 3 million people rely on the company's OneTouch® Blood Glucose Monitoring Systems for simple testing and accurate results. Now, LifeScan is also turning its expertise in patient self-testing to the development of monitoring systems for patients on warfarin therapy. For more information on the company's current blood glucose monitoring products, visit www.LifeScan.com.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts and assumptions that are subject to the risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Risks and uncertainties include general industry and market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign healthcare reform; trends toward managed care and healthcare cost containment, and governmental laws and regulations affecting domestic and foreign operations. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Cautionary Statement filed as an Exhibit to Johnson & Johnson's report on Form 10K for the fiscal year ended 31 December 2000. Copies of the Form 10K from Johnson & Johnson are available on request. The company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.)

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