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FDA approves next-gen intrathecal drug delivery system from Medtronic

The SynchroMed III system. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that the FDA approved its next-generation SynchroMed III intrathecal drug delivery system.

The medtech giant designed SynchroMed III to treat patients with chronic pain, cancer pain and severe spasticity. The targeted drug delivery (TDD) system alleviates symptoms by delivering medication directly to the fluid surrounding the spinal cord.

SynchroMed III builds upon the previous SynchroMed II system, featuring a new “refill only” physician workflow. This enables more efficient programming, while improved electronics feature firmware capable of updates post-implant. Additionally, the system has other protections for patient data through enhanced cybersecurity.

Medtronic said its system also carries forward several mid-generation durable design enhancements from the previous generation.

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Medtronic warns on previous software MiniMed 780G in Germany

The MiniMed 770G system. [Image from Medtronic]Medtronic (NYSE: MDT) + issued an urgent field safety notice in Germany to warn of a potential issue with its MiniMed 780G system.

MiniMed 780G, Medtronic’s next-generation automated insulin delivery system, has been available in Europe since earning CE mark in mid-2020. In March 2021, the company first communicated that its pumps with software version 6.5 could present pump errors. These occur after the delivery of a large bolus at quick bolus speed under certain conditions.

With its notice, Medtronic informed customers in Germany that they can exchange their current pumps for an updated version for free. Those with MiniMed 780G pumps with software version 6.5 can change to a pump with software version 6.7. This eliminates the potential occurrence of these errors so users can use the pump for boluses over 17.1 units at quick bolus speed.

This issue only impacts …

New data shows consistency of Medtronic MiniMed 780G in different demos, cultures

The MiniMed 770G system. [Image from Medtronic]Medtronic (NYSE: MDT) + today announced real-world data demonstrating the global consistency of its MiniMed 780G automated insulin delivery system.

The data demonstrates that using the system allows people with diabetes to meet or exceed internationally recommended targets regardless of location. Medtronic says a barrier to automated insulin delivery (AID) adoption and reimbursement in developing and middle-income countries has been a lack of data supporting its performance and cost-effectiveness in those regions. This comes as a result of large disparities in ethnic, cultural and regional representation in clinical and real-world studies.

Medtronic said its successful results support calls to provide AID systems within underserved populations. Data came from more than 67,000 MiniMed 780G users in Europe, the Middle East, Africa, Latin America, Oceania and Asia. The company p…

Medtronic has a new president of its Neuromodulation business

Paolo Di Vincenzo. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it appointed Paolo Di Vincenzo as the president of its Neuromodulation business.

Di Vincenzo’s appointment at Medtronic goes into effect on Oct. 30. In his new role, he holds responsibilities for the overall strategic direction of the company’s neuromodulation business and day-to-day operations.

Neuromodulation is part of Medtronic’s Neurosciences portfolio, comprised of Pain Interventions and Brain Modulation. The unit engineers innovative therapies and technologies to help patients relieve pain, restore function and reclaim movement.

Di Vincenzo joins Medtronic from Smith+Nephew, where he served as SVP and GM of U.S. advanced wound management. Over nine years at the orthopedic giant, he also served in global marketing and leadership roles.

Before Smith+Nephew, Di Vincenzo held a number of marketin…

Medtronic says defective McGrath Mac video laryngoscopes were stolen and offered for sale illegally

[Image courtesy of Medtronic]Medtronic (NYSE: MDT) + issued a notification to warn of stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties.

The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation.

Medtronic said it designated such devices for destruction. People should not use the defective McGrath Mac video laryngoscopes. The device facilitates the intubation of the trachea and using a defective device could result in patient harm. That includes failed laryngoscopy and/or intubation, potentially resulting in respiratory failure (including hypercarbia).

Other potential adverse effects include hypoxia, hypercapnia, tissue damage/trauma and…

Report: Private equity firm in negotiations for Medtronic business units

Medtronic (NYSE: MDT) + and private equity firm Carlyle Group reportedly entered negotiations over two units the medtech giant put on the spinoff block.

Nearly a year ago, Medtronic announced its intention to pursue a separation of its Patient Monitoring and Respiratory Interventions businesses. Both are part of the company’s Medical Surgical portfolio. Months later, reports surfaced citing Siemens Healthineers and GE HealthCare among those interested in the units. Later reports suggested ICU Medical joined the running as well.

However, Reuters reports that the company may go outside of medtech to sell its businesses. The outlet says Carlyle entered into exclusive negotiations for a majority stake in the units, valued at more than $7 billion. Reuters cited “people familiar with the matter.”

The report says, if a deal goes through, the units would move to a new company majority-owned by Carlyle. Medtr…

Medtronic wins CE mark for next-gen Simplera CGM with InPen integration

The InPen and Simplera system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received CE mark approval for its new Simplera continuous glucose monitor (CGM).

The all-in-one, disposable CGM features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Medtronic’s newest no-fingerstick sensor eliminates the need for overtape, too. It seamlessly integrates with the InPen smart insulin pen for real-time, personalized dosing guidance to simplify diabetes management.

Medtronic plans to begin a phased launch for Simplera at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting. It takes place in Hamburg, Germany, from Oct. 2-6.

Commercializing a new CGM comes at a good time for Medtronic, which could see the benefits from the newly popular GLP-1 drug class. Analysts recently outlined the ways in which those drugs m…

FDA grants IDE to Orchestra BioMed for cardiac neuromod trial in pacemaker patients

Rendering of the BackBeat therapy from an Orchestra BioMed YouTube demonstration.

Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial.

BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker.

New Hope, Pennsylvania-based Orchestra BioMed has the backing of medtech giant Medtronic in this effort. The companies announced a strategic collaboration to develop and commercialize AVIM therapy for pacemaker patients in July 2022. Under the collaboration, Medtronic offers development, clinical and regulatory support for the BACKBEAT trial.

Medtronic also contributed to a $110 million Series D at Orchestra BioMed, which soon went public through a …

How exposed are Medtronic, Intuitive and other Medtech Big 100 device makers to China?

China promises risk and upside for Medtronic, Intuitive and other major medical device manufacturers. [Photo via Adobe Stock]

As economic concerns shift from the U.S. to China, medical device manufacturers such as Medtronic and Intuitive are monitoring how procedure volumes and new policies affect their businesses.

In a new note, William Blair analyst Brandon Vazquez details the exposure of those companies and four more on Medical Design & Outsourcing‘s Medtech Big 100 ranking of the world’s largest device makers.

“The bottom line for our coverage universe is that exposure seems manageable with all companies at 10% or less of revenues/procedures coming from China, though we admit materially worsening macro conditions, if materialized, have the potential to move the needle on results — something we have already heard from some intra-quarter updates this month,” Vazquez wrote. Read more

Analysts: GLP-1 drugs should have minor impact on insulin pump market — but will boost CGMs

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies could be among those affected by the rise of the GLP-1 drug class. [Images courtesy of Insulet, Medtronic and Senseonics]Based on conversations with diabetes experts, analysts are playing down the potentially negative impact of GLP-1 receptor agonists on the diabetes technology industry.

The GLP-1 drug class, which includes Ozempic and Wegovy, has cast a shadow of doubt over diabetes technology of late. This therapeutic class, a glucagon-like peptide 1, has proven to lead to improved blood sugar control and weight loss.

In addition to the popular therapeutics, some companies — like i20 Therapeutics and Vivani Medical — are developing long-term implants that elute GLP-1s.

Positive clinical results from these drugs led to some negative market movement for a few of the biggest names in diabetes technology. Analysts even recently trimmed some forecasts o…

Lawsuit alleges ‘potentially problematic’ patient data sharing from Medtronic Diabetes devices

The MiniMed 780G (left) and InPen (right) insulin delivery systems. [Images courtesy of Medtronic]A class-action lawsuit filed against Medtronic (NYSE: MDT) + alleges that the company’s insulin delivery devices shared patient data with third parties.

The lawsuit, filed by plaintiff “A.H.,” levels allegations against Medtronic and its MiniMed and InPen devices. It addresses MiniMed’s transmission and disclosure of personally identifiable information and protected health information to Google and other third parties.

Per the lawsuit, the data was transmitted via tracking and authentication technology, including Google Analytics, Crashlytics, Firebase Authentication and related tools. A.H. says these technologies, installed on the website and/or mobile applications, includes the InPen iOS and Android applications.

“Information about a person’s health is among the most confidential and sen…

September 2023 edition: The Medtech Big 100

5 keys to Mike Mahoney and Boston Scientific’s success

How does medtech CEO compensation stack up to the rank and file?

Digital health startups to watch as Big 100 firms race to build or buy tech

DeviceTalks West show preview: Find solutions to your most demanding medtech problems

A mixed year for the Medtech Big 100 — and an opportunity to show we care

The results are in from our annual Medtech Big 100 ranking of the largest medical device companies, and while total sales and R&D spending are up, it doesn’t feel right to celebrate.

That’s because our analysis shows a 5% decline in employment across the industry. This is no surprise to anyone who is active on LinkedIn, given this year’s headlines about layoffs and posts from friends and co-workers seeking new opportunities.

It’s not the first time that’s happened. Last year’s analysis captured job cuts due to the COVID-19 pandemic that delayed procedures, snapped supply c…