Medtronic Supply Woes Buoy Insulin Device Makers
Medtronic supply woes buoy insulin device makers Share prices for makers of insulin management devices got a bump today after Medtronic (NYSE: MDT ) reported today that supply problems pushed sales down -1% for its diabetes division. The Fridley, Minn.-based company, which released its fiscal 2018 first-quarter results this morning, posted diabetes revenues of $449 million for the three months ended July 28. The decline was driven by strong demand for Medtronics CGM-enabled insulin pumps, especially the MiniMed 670G hybrid closed-loop device . The additional demand has resulted in fulfillment prioritization to the existing installed based, including MiniMed 670G priority access program customers, affecting sales of sensor-augmented pumps to new customers in the near-term. In addition, strong customer enrollment in its priority access program is also temporarily affecting revenue growth, Medtronic said . The strength of our diversification and solid underlying performance of our businesses, combined with the stable growth of our end markets, enabled us to manage the impact of a global IT system disruption and temporary diabetes sensor supply constraint, added chairman & CEO Omar Ishrak. While these temporary issues had affected first-quarter revenue growth, we continued to drive operating margin expansion. That news, and lower-than-expected sales for the entire company, pushed MDT shares down -2.2% to $81.71 apiece today, but buoyed shares of rival diabetes management companies including Dexcom (NSDQ: DXCM ), Tandem Diabetes Care (NSDQ: TNDM ) and Insulet (NSDQ: PODD ). DXCM shares were up 4.1% to $76.03 each, TNDMs stock rose 8.3% to $70.1 per share and PODD hit $57.44 for a 3.0% gain in late-morning activity. Continue reading >>
Fda Approves Hybrid Closed Loop System For People With Type 1 Diabetes
FDA Approves Hybrid Closed Loop System for People with Type 1 Diabetes The U.S. Food and Drug Administration (FDA) has approved Medtronics MiniMed 670G system, the first Hybrid Closed Loopinsulin deliverysystem in the world, according to a release from the company. This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease, says Derek Rapp, president and CEO of JDRF. We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA, and we are proud of the role JDRF played in achieving this exciting breakthrough. Medtronic and JDRF are committed to ensuring appropriate patient access to this therapy. The FDA approval of the worlds first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes, says Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic. We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy. The system is approved for the treatment of people with type 1 diabetes 14years of age and older with ongoing studies to expand the indication to additional patient populations. More details can be found at . Continue reading >>
Medtronic Begins To Roll Out State-of-the-art Insulin Pump
Two Minnesota teens with type 1 diabetes are some of the first patients in the nation to start using Medtronic's new insulin pump, a first-of-its-kind machine that can predict when a person will have a diabetic emergency and automatically adjust insulin levels to prevent it. Allison Scholl, 16, of Edina, and Eleanor Hedlund, 17, of Minneapolis, recently received their new Medtronic MiniMed 670G insulin pumps after using a similar but less-advanced Medtronic pump known as the 630G. Their new 670G units were officially activated on Wednesday in a manual mode, but both teens said they were eager to switch the devices into "auto mode" next week. "I'm a pretty avid endurance athlete. And it's obviously pretty hard to try and control blood sugar when you are constantly working out or being active," Hedlund said Wednesday after receiving training on how to use the device at Park Nicollet's International Diabetes Center in St. Louis Park. "I'm hoping that it will make me able to train more, or not have to drop out of practice. ... Hard workouts are hard to do when your blood sugar is out of whack." Scholl, meanwhile, was a longtime user of a different company's insulin pump. She said she switched brands last fall after Medtronic announced a "Priority Access" program that allowed people who purchase a 630G system to be "first in line" when the newer 670G is available commercially, which happened this week. Medtronic is hoping other type 1 diabetics will follow Scholl's lead and get in line for the 670G. Company CEO Omar Ishrak said in an earnings call with investors in February that Medtronic diabetes-device sales may slow during the quarter ending in April, as patients postponed purchases in anticipation of the 670G. But Ishrak also reiterated that Medtronic's diabetes business Continue reading >>
An Update On Medtronic’s Minimed 670g System
This morning, the Medtronic Diabetes Group held a conference call for a small group of diabetes writers to give an update on its new MiniMed 670G system, otherwise known as the world’s first hybrid closed loop system. Louis Dias, Chief Patient Officer of Medtronic Diabetes and Mike Hill, Vice President of Marketing for Medtronic’s Intensive Insulin Management Business were both on the call, as was Karrie Hawbaker, Senior Manager of Social Media. First, a recap on what the system is and what it does: The MiniMed 670G system is a combination of an insulin pump and a continuous glucose monitor. What sets it apart from its predecessors—and, for that matter, every other pump on the market—is that it can actually give you insulin. This makes it a major step forward toward the goal of a truly closed loop system. How does the 670G system work? Users must program their insulin-to-carb ratios, calibrate the system twice a day with a blood glucose reading from a finger stick, and give the system a “meal announcement” when they’re about to eat by entering the number of grams of carbohydrate that they intend to consume. The system then uses the grams of carbohydrate users have entered and their insulin-to-carb ratio to estimate an initial bolus to cover the meal. In the hours that follow, the system makes tiny tweaks to basal rates in order to get blood sugar levels as close as possible to 120 mg/dL. This means that you don’t need to enter correction boluses and that there’s no longer such thing as dual wave or square boluses—the pump is taking care of it for you. How’s it different from the most recent MiniMed pump? Medtronic Diabetes’s current top-of-the-line pump is the MiniMed 630G system with Enlite Sensor. The 530G uses something called SmartGuard™ te Continue reading >>
A Closer Look At The Medtronic 670g: Dr. Bruce Buckingham
The diabetes community is eagerly awaiting the spring 2017 release of Medtronic’s Minimed 670G. It’s the world’s first hybrid closed loop system, and at this point it’s the closest thing to an artificial pancreas that the diabetes community has. But what’s it like, really? The best people to ask would be the people who developed it: Dr. Bruce Buckingham and his research team at Stanford, along with people who have actually used it — the testers who have participated in Dr. Buckingham’s studies and medical trials. ABOUT THE 670G A few weeks ago Dr. Buckingham gave the community a closer look at the 670G: its features, capabilities, and areas for improvement. Here’s a rundown: DISCLAIMER: The description of the 670G is accurate at the time of reporting; however, the final, commercially available version may be different from the version described here. Components The system uses Medtronic’s newest sensor, the Guardian (formerly known as Enlite3). This sensor is not backwards compatible with any of Medtronic’s older pumps. The meter can be used as a remote bolusing device. The 670G pump contains the insulin delivery algorithm. It has an insulin reservoir, tubing, and color screen. The pump is waterproof to 12 feet for 1 hour. Operation In manual mode, the pump uses programmed settings just like other pumps There are 3 auto modes: suspend on low (similar to Medtronic’s 530G), suspend on predicted low, and hybrid closed loop. When in hybrid closed loop mode, the system acts as a basal rate modifier, giving insulin (via 5-minute microboluses) if running above target, and suspending insulin if low. The system has a fixed glucose target set at 120 and a correction target fixed at 150. There is also a temp target setting of 150 for driving or exercise, but Continue reading >>
Priority Access Faqs
The Priority Access program was a special pathway offer for new and existing Medtronic customers who purchased the MiniMed 630G system between August 10, 2016, and April 28, 2017. Participants were eligible to purchase the MiniMed 670G system at a special pathway price and were among the first in line to access our latest technology. For eligible participants, the opportunity to upgrade to the MiniMed 670G system through the Priority Access program ended on July 28, 2017. For more information about eligibility for upgrade programs, click here . Im enrolled in Priority Access. What are the requirements for the program? The Priority Access program offered customers who purchased the MiniMed 630G system between August 10, 2016, and April 28, 2017, the opportunity to upgrade to the MiniMed 670G system for as low as $0. The price to upgrade to MiniMed 670G system through Priority Access was $799 Participants receive a $500 credit for the return of the MiniMed 630G pump and transmitter Pump and transmitter must be returned within 180 days of the MiniMed 670G pump shipment date If the MiniMed 630G pump is not returned, customers will be charged $3,700 for the full system Participants have the option to reduce the remaining $299 down to $0 by participating in the System Access program described below The System Access activities and the return of the MiniMed 630G pump and transmitter must be completed within 180 days of the MiniMed 670G pump shipment date Can you tell me more about the System Access activities that I have to complete to take $299 off the cost of the MiniMed 670G system? Because were a regulated industry, there are strict rules about the credits we can offer. Thats why we offer System Access, so you can leverage your experience to provide Medtronic with valuabl Continue reading >>
Medtronic's Priority Access Problems
For the last 2 1/2 months I been told the new 670G was being shipped to me that week and as today its no where in site! Dealing with Medtronic's is like dealing with a use car lot to honor a warranty it provided. I have heard every excuse and reason why its not here to me. Then you read a statement by the company that all Priority access customers will have their new pumps by the last week in February to add insult to injury. Sorry, letting off stream about them but, I was wondering anyone else is going thru this problem with them. The local Medtronic's trainer has done everything he could to find out when it will be ship but no luck. My Doctor has offer to call the company to find out what is their problem but I told him to wait until my next appointment if I haven't received it by then. I have been told all Priority Access customers will get their pump before new orders get theirs....which is hard to believe. Let me know if you or someone you know is going through the same problem. D.D. Family Type 2 since 1993, on pump since 3/10 I got my 630 in February, 2017 and started calling for availability on the 670 upgrade the following September. And called semi monthly thereafter. In November, I was told that production problems following the hurricane in Puerto Rico were holding up the upgrade orders. In late November, I was told that all priority upgrade back orders would be shipped by year end. I finally got mine In early February 2018. I wouldn't mine waiting so much if they said the truth about the delays. To me that is not a good way to keep customers. The FDA and Medicare, and other companies are coming out with products that do the same and most likely a little better. The government is moving faster than ever on new drugs and equipment for diabetes than ever. In Continue reading >>
Artificial Pancreas In Limbo For Diabetics Covered By Anthem
Anthem to reconsider decision not to cover artificial pancreas ‘I’m scared and I’m frustrated:’ Anthem customer in limbo Health insurer Anthem Inc. will reconsider its decision not to cover an artificial pancreas for diabetics sold by Medtronic Plc, one of the medical company’s most promising new products. It would be a welcome change for Medtronic, but one that comes too late for many patients who paid thousands of dollars out of pocket months ago to get access to the breakthrough insulin-pump system. “They have my device and are sitting on it,” said Faith Cohen Schoenfeld from Tarzana, California, who’s anxious for her 17-year-old diabetic son to get the system before he departs for college next year. “I’m scared and I’m frustrated.” Anthem patients who enrolled in Medtronic’s priority-access program for its new device were caught in the crossfire after the insurer deemed the system “investigational and not medically necessary,” making it the sole holdout among major U.S. insurance companies. Medtronic, which didn’t anticipate the rejection, won’t ship those patients the product, MiniMed 670G, until they get proof that Anthem will cover the supplies needed to run it. Yana Katzap-Nackman, who has two children with type 1 diabetes, is also left in that limbo. “For me to know that somebody out there is sitting in an office and making decisions that are life-changing, and they decide you don’t get this, you don’t get to feel better, you lose; I think there is something wrong with that,” said Katzap-Nackman, who’s also diabetic. When contacted by Bloomberg News, Anthem defended its May decision, saying its medical policy and technology assessment committee found that there wasn’t enough evidence to justify coverage. Only 300 pa Continue reading >>
Important Update On Minimed 670g Availability And The Priority Access Program
Last fall we announced the FDA approval of the world’s first hybrid closed loop system and it was one of the proudest days of my career. After 35 years of innovation, we’re thrilled to make this revolutionary technology a reality. The MiniMed 670G® system is the most advanced insulin pump and sensor system that is personalized to your life and your diabetes. The response from the diabetes community has been incredibly touching and we thank you for all of your feedback along the way. Over the last few months we’ve been preparing our manufacturing, training and education – key steps to bringing the product to market. We know that anticipation for the new system is incredibly high and have been working as quickly as possible. But we also take our responsibility as an innovation leader seriously and are committed to taking the time needed to ensure that everyone has the best possible experience on this new system. Today we’re here to share an important update on the rollout of the MiniMed 670G system. Priority Access Program Those who purchased the MiniMed 630G system between August 10th of 2016 and April 28 of 2017 may be eligible to participate in the Priority Access program. These people have the opportunity to be among the first in line to upgrade to the MiniMed 670G system. The reason is that we believe those already using our newest pump platform will experience the easiest and quickest transition to the new system. First Step: The Customer Training Phase As we prepare to make the MiniMed 670G system available to everyone, we’ll start out with a small group of Priority Access program participants at a select number of people with diabetes and healthcare provider sites. This Customer Training Phase will allow us to validate the training and onboarding prog Continue reading >>
Medtronic Slows In Q2 But Expects Growth To Pick Back Up
Medtronic slows in Q2 but expects growth to pick back up Growth in Medtronic's diabetes unit dipped due to limits on the supply of CGM sensors, but the company plans to expand its sensor manufacturing by Q4. Medtronics sales took a 4% hit in the second quarter, which the company attributes to the impact of Hurricane Maria on its operations in Puerto Rico, as well as the divestiture of a trio of businesses to Cardinal Health. Excluding the approximate $55 million to $65 million impact of Hurricane Maria to the company's revenue, which was split across the company's Minimally Invasive Therapies Group and Restorative Therapies Group, second-quarter revenue growth would have been 4% on a comparable, constant currency basis, the company said in a statement. The full-year guidance for both the Minimally Invasive and Restorative Therapies groups have been adjusted due to the hurricane, but the formers growth will ramp up in the second half, with many product launches on the horizon in fiscal 2018, said CEO Omar Ishrak on the second-quarter earnings call. Like this story? Subscribe to FierceBiotech! Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go. Continue reading >>
Finding Freedom With The Medtronic 670g
I didnt know what to expect when I got word that I was eligible for Medtronics trial priority access program for theirclosed-loop insulin system, the MiniMed 670G. I was nervous, and I was excited. But after having T1D for 33 years (I was diagnosed at age 3), I have in the last few weeks found new levels of freedom. The science behind Medtronics artificial pancreas is remarkable, but, like any new best friend, it takes time to build trust and confidence. During the past few weeks, I have faced many emotional highs and lows. The highs and lows of my blood sugars, however, are starting to stabilize. At first, I was very uncertain. I believed that I was more in tune with my body than most people. I believed the equations I had used to survive for the past 33 years were irreplaceable. But now Ive reached a place where I can honestly say (and its strange to think this) that the scientific algorithm used by myartificial pancreas may have me beat. Here are my reflections after my first month with an artificial pancreas. I hope you can learn from my journey. Being on a new medication or new medical device requires evaluating and changing what you have always done. I realized during my first few weeks with the 670g that I had some bad habits that had always worked but no longer would. For instance, before I wasnt completely accurate with my carb counting, relying on the correction factor throughout the day. I was also padding with larger basal rates so I didnt have to bolus that much. I now need to un-learn these habits for the 670Gs algorithm to work best. I want everything to be fixed now. Thats partly what the 670G advertising made me believe would happen. I have come to realize that patience is key. After un-learning my bad habits, I had to have the patience to let the syst Continue reading >>
Diabetes Double Play: Medtronic Launches Minimed 670g, Dexcom Wins Fda Nod For Android G5 App
UPDATE: Updated to include comments from Ascensia Medtronic (NYSE:MDT) and Dexcom (NSDQ:DXCM) today announced respective wins for their diabetes care tech, with Medtronic launching its hybrid closed loop MiniMed 670G in the US and Dexcom winning an FDA nod for a Google (NSDQ:GOOG) Android G5 Mobile application. Fridley, Minn.-based Medtronic’s MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering or withholding insulin. The newly launched system includes a body-attached sensor to track glucose levels under the skin, a worn insulin pump and an infusion patch connected to the pump with a catheter to deliver insulin. The device is designed to automatically adjust insulin levels, but requires manual entry of carbohydrates consumed and approval for bolus correction recommendations. “The response from the diabetes community has been tremendously positive and we are proud to be leading this remarkable period in diabetes history in partnership with the clinical and advocacy communities. We’ve essentially designed a smarter insulin pump that alleviates some of the burden associated with diabetes management, which can be unrelenting and exhausting. We are very excited to see that real-world insights from our Customer Training Phase reinforce the positive outcomes demonstrated through our pivotal trial of the system,” intensive insulin management division prez Alejandro Galindo said in a prepared statement. The hybrid closed loop system features Medtronic’s SmartGuard algorithm, which the company says is the 1st step on its phased approach towards developing a fully automated, closed loop system. The MiniMed 670G also includes the company’s Guardia Continue reading >>
Cgm Sensor Delays Plaguing Medtronic | Diabetesmine
We're sorry, an error occurred. We are unable to collect your feedback at this time. However, your feedback is important to us. Please try again later. Not surprisingly, there's been a lot of hype about Medtronic's new 670G "hybrid closed loop" semi-automated insulin delivery system since it was approved by the FDA just over a year ago. After all, it's the first of its kind -- so far the only "pre-Artificial Pancreas" technology connecting an insulin pump and continuous glucose monitor with smart algorithms that's gotten the green light from regulators, much quicker than anyone expected in fact. Truly, there's a lot to be exited about. Yet despite all the good vibes (and mostly good press), Medtronic has faced a number of speed bumps over the past year -- from the company's slower-than-announced rollout that left many would-be customers frustrated, its inability to keep up with the high demand for CGM sensors and other supplies, to Anthem's initial refusal to cover the 670G, and Hurricane Maria in September hobbling Medtronic's Puerto Rico manufacturing operations. Of course any company can be hit with operational snags, or be affected by a natural disaster. But what makes this particularly alarming for the D-Community is the contracting of the diabetes device market these days, with a Nov. 12 Star Tribune story noting that some now see Medtronic as the "only game in town" for some of these products. With the insulin pump market shrinking and access to diabetes necessities becoming more uncertain, Medtronic is edging ever closer to monopolizing this med-tech segment and that means people with diabetes may not have many options except to make do. Bottom line: Many patients face fewer choices, and are afraid of being left twisting in the wind if they can't even get acces Continue reading >>
Asknadia: Getting Anthem Health Insurance To Cover Medtronic’s 670g Insulin Pump Supplies
This column is a request from people and families living with Type 1 diabetes, that is dealing with an insurance company that refuses to adopt industry standards, by paying for insulin pump supplies like their competitors for a medical device upgrade. The upgrade from the Medtronic 630 G insulin pump and supplies to the 670 G pump, offers no additional cost to the insurance company. You can support your fellow Type1’s by calling and emailing the press people from both companies; requesting a resolution for the long list of families who are caught in an administrative snafu which is not being addressed. The Anthem press person is Olga Gallardo and you can reach her at 818-201-5682 and the Medtronic press person is Janet Kim and you can reach her at 818-403-7028. Dear Nadia: Anthem is the only national insurer not covering the new Medtronic 670G system, which is a major step forward in diabetes management. As you may know, Medtronic promoted the system through its Priority Access program, which urged families to pay nearly $4,000 from their own pockets to get the 670G system first. Because Anthem refused to cover the system, Medtronic now won’t ship the 670G systems to these families who purchased the system because Anthem won’t cover the supplies needed for the system. Medtronic requires a letter from Anthem saying it will cover the supplies – a request that Anthem customer service reps and supervisors don’t even understand because the 670G is not on their formulary. Families usually just go through the appeals process to get Anthem to cover the supplies, they can’t: They have no denial of coverage because Medtronic won’t ship them the 670G system. With no new system, there are no new supplies and no denial to appeal. Whether Anthem subscribers can get the Continue reading >>
Medtronic 670g To Begin Launch Soon. (copied Email) : Diabetes
Welcome to the MiniMed 670G system Priority Access program! We thank you for signing up to be among the first to experience this revolutionary technology. As we prepare to make this therapy available to those who signed up for Priority Access, we will start out with a small group of patients and healthcare providers to ensure that everyone going on the system has a great experience before launch. This Customer Training Phase will start in March. We look forward to applying what we learn in this phase to ensure that you have the best experience possible. We will begin shipping MiniMed 670G systems later in the spring, when youll be among the first individuals to start on the system as part of the Priority Access program.In the coming months, well send you a text message with instructions for how to place your order. We also want to take this opportunity to describe our System Access program. This program gives you the opportunity to provide us with valuable feedback and be compensated for your time. Heres how the program works: When we ship your system, we will create a debit on your account in the amount of $299 We need your feedback through the following activities. Completing each activity will reduce the debit on your account by its value described below: Your story (valued at $75) CareLink software data uploads and access (valued at $99) You will receive a series of emails inviting you to complete each of the surveys and instructions for submitting your story Please complete these activities within 120 days of shipment to ensure that your account is creditedIn the meantime, to learn more about the MiniMed 670G system, click here. You can also learn more about the Priority Access program by clicking here. Continue reading >>
