Hello questionz02-ga,
The Medtronic Minimed Paradigm 512 wireless insulin pump system was
approved by the FDA earlier this year and the company announced the
product’s availability in a press release dated July 7, 2003. This
press release is widely available from many diabetes related Web
sites. There is not much available in the way of user or physician
reviews although I have located some materials that will answer your
request for 3rd party comments. My research showed that this new pump
started shipping on July 21 but I wasn’t able to find any sales
figures yet. Medtronic’s financial reports and industry analysts cite
expected sales figures in light of the current population of about
200,000 pump users. The FDA workshop report on Innovative Systems for
Delivery of Drugs and Biologics might be of special interest to you
with it’s discussion of the four major partnerships in the continuous
blood glucose monitoring field.
I’ll be happy to clarify any part of this answer before you rate my
research. I trust that the information I’ve located will meet your
needs.
Good luck with your explorations.
czh
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REVIEWS OF MEDTRONIC MINIMED INSULIN PUMP SYSTEM
================================================
http://www.diabetesmall.net/diabetes_technology/insulinpumps_minimed.php
Medtronic MiniMed's Paradigm 512 Insulin Pump replaces the original
Paradigm model which has had problems losing basal rates when the
battery is removed or when static electricity strikes. Wiring and
soldering are said to be improved with an unstated modification to
protect memory when the battery is removed. The battery can be removed
for 30 to 40 minutes before the pump's time is lost, and basal rates
are said to be protected for a month without a battery. Despite the
design flaws not seen with other pumps, Medtronic will charge current
Paradigm users $450 to upgrade. …
Safety issues exist that users and clinicians should be aware of. The
Paradigm can deliver good control, but the wearer must keep a few
issues below in mind to avoid major problems.
***** See list of problems and necessary user actions.
http://www.bgmeters.com/
Introduction to BG Meters.COM
At bgmeters.com, I review blood glucose meters and other new
diagnostic tools designed for use by diabetics in the home.
I'm a type I diabetic with a strong history of type I diabetes in my
family. I am a 43 year old father of three, and an electrical
engineer.
I test between 4 and 6 times daily. I became a Minimed 508 insulin
pump user about 2 years ago, and have since upgraded to the Paradigm
pump.
The site is not sponsored by any meter manufacturer. My motivation
for running this site and writing independent reviews- I want meter
manufacturers to continue development of high quality, low cost
products for diabetics.
***** This review takes the news release from Medtronic and comments
on the new pump from a user’s perspective.
http://www.islet.org/forum/messages/27468.htm
New Insulin Pump/Blood Glucose Monitor by Medtronic
Posted by Tristan Jones on July 07, 2003 at 19:19:44:
Does anyone have any information on this pump?
***** This is a discussion thread that has comments from users of the
forum sponsored by The Islet Foundation.
“For the last thirty years, research at universities and private labs
has moved slowly toward achieving a cure for insulin-dependent
diabetes. The Islet Foundation (TIF) is dedicated to supporting the
"final push" for that research effort, a push that may provide a safe
and viable cure for millions of diabetics.”
http://www.diabetesnet.com/diabetes_technology/data-failure.php
Improving Today's Meters: Why They Fail The Control Test
Don't blame yourself for all those bad readings if your meter
continues to omit data analysis.
Meter company advocates say that health care outcomes is not their
job, and, actually, they are correct. So if health care outcomes means
getting blood sugars under control, whose job is it? It is you and
your physician's job. But your job is made much harder today because
the information given by your meter is presented so ineffectively that
few consumers or health providers use it.
***** See 163 comments posted by various users describing their
experiences with various methods and devices.
==============================
PRODUCT APPROVAL ANNOUNCEMENTS
==============================
http://www.fda.gov/cdrh/pdf3/k030531.pdf
FDA Decision
DEVICE: MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD
PAR
MINIMED, INC. 510(k) NO: K030531(TRADITIONAL)
ATTN: GERDA P RESCH PHONE NO : 818-362-5958
18000 DEVONSHIRE ST. SE DECISION MADE: 17-JUN-03
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00918.html
FDA Clears New Diabetes Device for Marketing
FOR IMMEDIATE RELEASE P03-49
July 7, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
The Food and Drug Administration (FDA) has cleared the first device
for diabetics which integrates a glucose meter and an insulin pump
with a dose calculator into one device. The new device could be the
first step in the development of a fully automated glucose monitoring
and insulin delivery system.
The product, made by Medtronic MiniMed, Inc., and Becton Dickinson,
combines the Medtronic MiniMed Paradigm insulin pump with a Becton
Dickinson glucose monitor and facilitates data interchange between the
two. It has additional circuitry and software modifications that allow
it to transmit glucose values to the insulin pump and to transfer data
between the insulin pump and a personal computer running the
appropriate Medtronic MiniMed communications software.
http://www.cbsnews.com/stories/2003/07/08/tech/main562162.shtml
New Diabetes Device Adds Up
WASHINGTON, July 8, 2003
….. More than 200,000 diabetics have insulin pumps implanted in their
abdomens, a programmable system that can provide more precise, regular
doses, infusing even while the patient is sleeping if necessary. But
patients still have to test their blood sugar and then do some math to
decide how much their pumps should emit and when.
With the new system, patients still will perform the glucose test. The
pager-sized glucose monitor uses wireless technology to beam the
result straight to the implanted insulin pump.
….. Medtronic said the prescription-only device will begin shipping
July 21 and cost $5,995, $500 more than Medtronic's manually
programmed insulin pump.
===============================================
MEDTRONIC FINANCIAL AND COMPETITIVE INFORMATION
===============================================
http://www.biz.uiowa.edu/henry/MDT.pdf
Henry Fund Research, Tippie School of Management, University of Iowa
November 21, 2002
Industry: Medical Devices – Medtronic (MDT)
Investment Recommendation: Hold
***** See page 6 for a discussion of Medtronic’s acquisition of
MiniMed and the increased growth projections based on sales of insulin
pumps.
http://www.edgar-online.com/lycos/quotecom/glimpse/glimpse.pl?sym=MDT
http://biz.yahoo.com/e/l/m/mdt.html
July 14, 2003
MEDTRONIC INC (MDT)
Annual Report (SEC form 10-K)
***** See pages 16 – 19 for a discussion of the acquisition of MiniMed
and the expected growth in the diabetes segment of the business.
http://www.fda.gov/ohrms/dockets/dockets/03n0203/03n-0203-tr00001-01-vol2.pdf
UNITED STATES OF AMERICA -- FOOD AND DRUG ADMINISTRATION
WORKSHOP ON INNOVATIVE SYSTEMS FOR DELIVERY OF DRUGS AND BIOLOGICS:
SCIENTIFIC, CLINICAL, AND REGULATORY CHALLENGES
TUESDAY, JULY 8, 2003
Comments by DAVID C. KLONOFF, M.D., U.C. San Francisco
…. Now, the next option that has become available for patients is
continuous blood glucose monitoring. There are four products that one
can use in the world for continuous blood glucose monitoring or
continuous glucose monitoring. Two of them are available in the
United States and Europe, and the other two are available only in
Europe and are not FDA approved for use in the U.S.
***** See extensive discussion starting on Line 18, Page 85 that
covers emerging developments in continuous blood glucose monitoring
from various medical device manufacturer and drug company
partnerships.
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SEARCH STRATEGY
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Medtronic MiniMed Paradigm 512
continuous glucose monitoring minimed 512 |
