Medtronic announced FDA approval this morning for its stand-alone glucose sensor. As a reminder, the 522/722 pump has been shipping since April, and the sensor/transmitter that is part of that system has been shipping since June 19. Items of note:
1. This product has predictive alarms and rate of change alarms - this is a more advanced suite of data than the sensor that is part of the 522/722 and as such a positive for Medtronic.
2. Calibration is every 12 hours and sensors are "typically" used for three days. In terms of outcomes, the release says that CGM technology identifies four-times more glucose excursions requiring therapy adjustment than just fingerstick monitoring alone. REAL-Time alarms help reduce the duration of hypoglycemic (low blood sugar) episodes by 48 percent. (This hasn't been published that we're aware of but we believe it's data from last year's EASD)
3. It will be launched by the end of the year, so it will be some time before it is available so won't immediately compete with Dex Com.
4. There is no pricing information as of yet for this product.
5. Other features that are attractive to users are that it is waterproof, it has expanded trend graphs - 3, 6, 12, and 24, hours (Dex Com has 1, 3, and 9) showing the effect of diet, exercise, medication, and lifestyle on glucose values.
6. Feedback has been very good on the Medtronic CareLink software as you know and we would expect that to be a big part of marketing for this product.
7. It sounds like it would be some time (12 - 18 months) before these extra data features would be incorporated into the 522/722.
8. Although this won't be launched til year-end as noted, it will be shown at AADE, so we will look forward to checking it out in LA in a few weeks (Aug 9 - 12).
9. Medtronic has more experience than any other company in this area. The press release below says Medtronic has shipped nearly 500,000 sensors to date (this would include CGMS we assume)
10. This is a modest positive to Medtronic although we assume it's primary focus continues to be its pump business. It won't compete immediately wiht Dex Com but the approval is a reminder that other competition is coming for Dex Com's STS (and for Abbott's Navigator,not yet approved).
Press release below.
Source: Medtronic, Inc.
Medtronic Receives FDA Approval for Guardian(R) REAL-Time Continuous Glucose Monitoring System
Monday July 17, 7:00 am ET
System Provides Patients Superior Protection than Fingersticks Alone
MINNEAPOLIS--(BUSINESS WIRE)--July 17, 2006--Medtronic, Inc. (NYSE:MDT - News) today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardian® REAL-Time System, a doctor-prescribed continuous glucose monitoring (CGM) system for improved diabetes management. Especially well suited for diabetes patients who frequently monitor their glucose levels, the Guardian REAL-Time System is intended to help protect patients by alerting users to high and low glucose levels. The REAL-Time information and retrospective glucose trend data provided by the Guardian REAL-Time System are designed to help patients more tightly control glucose levels. Improved glucose control has been shown to significantly reduce the likelihood of certain long-term complications, including blindness, kidney failure, amputation, impotence, and heart disease. The system will be available nationwide by the end of this year.
Source: Medtronic, Inc.
The FDA-approved Medtronic Guardian(R) REAL-Time Continuous Glucose Monitoring System alerts diabetes patients to high and low glucose levels, allowing them to better manage their diabetes. (Photo: Medtronic). View Multimedia Gallery
"The Guardian REAL-Time System is the culmination of more than seven years of research into continuous glucose monitoring technology," said Robert Guezuraga, president of the Diabetes business at Medtronic. "With more than 2,400 patient years of glucose monitoring, and more than 470,000 glucose sensors shipped, Medtronic is leading the way with the newest generation in continuous glucose monitoring technology."
Unique features only available with the Guardian REAL-Time System include predictive and rate-of-change alarms and expanded trend graphs. In addition to high and low glucose alerts, these new predictive alarms are designed to warn patients of significant glucose changes well before they become dangerous. Comprehensive trend graphs show the effect of diet, exercise, medication, and lifestyle on glucose values in three, six, 12, and 24 hour increments. All glucose data can be downloaded using the Medtronic CareLink® Therapy Management Software.
The Guardian REAL-Time System glucose sensor is a tiny electrode inserted under the skin that measures glucose levels in the interstitial fluid found between the body's cells. The sensor is connected to a transmitter that sends glucose readings every five minutes to a monitor, which displays up to 288 readings a day - nearly 100 times more information than conventional monitoring.(a) This additional information provides better protection against frequent glycemic highs and lows, and empowers patients to be more proactive about their diabetes management. CGM technology identifies four-times more glucose excursions requiring therapy adjustment than just fingerstick monitoring alone. REAL-Time alarms help reduce the duration of hypoglycemic (low blood sugar) episodes by 48 percent.
The Guardian REAL-Time System is indicated for continuous or periodic monitoring of glucose levels of adults (ages 18 and older) with diabetes mellitus for the purposes of improving diabetes management. The glucose sensor is typically discarded and replaced after three days of use. All therapy adjustments should be based on measurements obtained using a blood glucose meter (fingerstick measurement). The device requires one calibration point every 12 hours.
Current standards for assessing glucose control include A1C tests and fingerstick measurements, yet both have limitations. An A1C test, which measures glucose control during a three-month period, is important for long-term management, but it is only an average and and does not reveal day-to-day glucose fluctuations that can harm the body. In turn, fingerstick measurements only reveal a glucose value at a single moment in time. As a result, patients are unable to detect approximately 60 percent of hypoglycemic events, and have difficulty assessing glucose fluctuations while they sleep.
Medtronic Diabetes currently markets the CGMS® System Gold and the recently FDA approved MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System – the world's first insulin pump with REAL-Time continuous glucose monitoring. The MiniMed Paradigm REAL-Time System has all of the benefits of CGM plus the added value of precise insulin delivery through the use of insulin pump therapy. Medtronic Diabetes continues to lead the industry in developing new medical device technologies to improve overall diabetes management.
According to the American Diabetes Association, almost 21 million Americans (seven percent of the population) have the disease. Diabetes affects children and adults, costing the United States more than $132 billion in direct and indirect costs.
* Based on three fingersticks a day
About Medtronic’s Diabetes Business
The Diabetes business at Medtronic (www.minimed.com) is the world leader in diabetes management. The company’s products include insulin pump therapy, continuous glucose monitoring systems, related disposable products and diabetes management software.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology, alleviating pain, restoring health and extending life for millions of people around the world.