RECALL: Medtronic Infusion Sets
From Medtronic
Explanation of the Issue
Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue.
Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk.
To see if your infusion sets are part of the recall please go to this page supplied by Medtronic
https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice7-letter
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Further Press release
Medtronic deal with Aetna ties insulin pump payment to patient results
This does not feel right...
My opinion.... Medtronic has way too much power in the insulin pump space. You may also want to check out Mike Hoskin's thoughts on the subject over at Diabetes Mine.
By Bill Berkrot Reuters
Medtronic Plc said on Monday it signed an agreement with health insurer Aetna Inc under which payment for its insulin pump systems will be tied to how well diabetes patients fare after switching from multiple daily insulin injections.
The deal is the latest example of the move toward contracts for prescription drugs and medical devices that attempt to bring down soaring healthcare costs by tying reimbursements to whether the products achieve their intended results.
The deal with Aetna will measure health outcomes for patients who transition to one of three Medtronic pumps that self-adjust to keep blood sugar levels in proper range based on patients' individual needs for insulin.
"This agreement reinforces our shift towards value-based healthcare," Hooman Hakami, president of the Medtronic diabetes group, said in a statement. "We know technology alone isn't enough and ultimately improved outcomes are what matter."
Patients with type 1 diabetes and those with type 2 who have progressed to the need for insulin typically check blood sugar levels several times a day and inject insulin as needed. The pumps eliminate that chore.
Medtronic declined to discuss financial details of the Aetna agreement, but said such deals tie revenue to achievement of clinical improvement targets, as well as shared savings for delivering on or exceeding clinical outcomes and cost targets.
Suzanne Winter, vice president of the Medtronic diabetes group in the Americas, said the Aetna agreement will initially focus on whether patients on its pumps achieve their A1c targets, a commonly used measure of blood sugar levels. The American Diabetes Association recommends A1c levels below 7.
In the future it may look at other measures, such as hypoglycemia episodes, time in proper glycemic range, and patient satisfaction, Winter said.
Medtronic already has an agreement with UnitedHealth Group Inc that is moving toward including patient outcomes and other metrics, such as total cost of care, and the company is discussing similar deals with other insurers, Winter said.
Pharmaceutical companies are also beginning to embrace reimbursement options that take patient outcomes into consideration.
U.S. biotech Amgen Inc, in an effort to improve patient access to its expensive new cholesterol drug Repatha, has offered contract options that include refunding the cost of the drug if patients suffer a heart attack or stroke while on the medicine intended to prevent them.
(Reporting by Bill Berkrot; Editing by David Gregorio)
Diabetes Tech News: Medtronic Launches First-Of-Its-Kind mySentry™ Remote Glucose Monitor
Medtronic announces mySentry and I rejoice. Their new innovation does sound familiar...
mySentry Allows Caregivers to See Real-Time Insulin Pump Information and Glucose Trends from Another Room
MINNEAPOLIS – January 4, 2012 – Today, Medtronic, Inc. (NYSE:MDT) announced U.S. Food and Drug Administration (FDA) approval and U.S. market launch of the first-of-its-kind mySentry™ Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm® REAL-Time Revel™ System. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that will provide people with diabetes and their caregivers convenient options to access their diabetes management information.
Perhaps more then any other chronic dieses, management of day-to-day diabetes lends itself to cutting edge technology. While I'm always grateful for the advancements that have already been made, I'd like to see more and see it faster.
Even if you don't use a Medtronic device (Arden uses a DexCom CGM) this news is fantastic. Wireless technology like this is sorely needed and Medtronic's announcement will serve us all well, spurning other manufacturers to move forward as quickly as possible so not to be left behind. It is also a signal to other companies that the FDA is allowing clearance for technology such as this. That knowledge will make it easier for smaller companies to get into the game. Many device manufacturers are smaller and less profitable then you may imagine and they can't afford to get trapped into a protracted submission process with the government.
I love the FDA saying yes, I love Medtronic trying and I look forward to finding out what is next - please just don't price us all out of when your products come to market.
Medtronic's complete press release is at this link.
ps. It's time to let Insulet give us their smaller pods FDA - I mean really... which ever device lobbyist has you holding this up (my supposition)... they've gotten their monies worth, time to think about the people again.