Medtronic Archives - Medical Design Sourcing

Medtronic plans job cuts in California

Medtronic (NYSE:MDT) + is eliminating 44 jobs in Carslbad, California, according to a mass layoff notice filed with the state.

The permanent job cuts take effect starting on or around May 19 at 2101 Faraday Ave., Medtronic told the California Employment Development Department.

FDA records list that address as a facility for Nellcor Puritan Bennett Corp., a respiratory monitoring and ventilator brand that Medtronic acquired when it purchased Covidien.

In 2022, Medtronic said it wanted to spin off the Medical Surgical portfolio’s Patient Monitoring and Respiratory Interventions businesses, but no buyers emerged.

Instead, Medtronic said earlier this year that it planned to exit the ventilator market, saying the move would eliminate up to 40 jobs in Ireland. At the same time, Medtronic said Bob White, an EVP and president of the Medical Surgical portfolio, was leaving the company in a new round of reorg…

First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks

The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that’s unique within Medtronic’s PFA device portfolio.

The Medtronic Sphere-360 pulsed field ablation catheter is adjustable, allowing it to take different shapes inside a patient. [Illustration courtesy of Medtronic]

Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world’s largest device manufacturer.

In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac Ablation Solutions, discussed the Sphere-360’s design and features.

The large-lattice, over-the-wire PFA Sphere-360 catheter — which Medtronic purchased through its acquisition of Affera — is investigational in the EU …

FDA approves Medtronic’s Inceptiv closed-loop rechargeable spinal cord stimulator

The Inceptiv spinal cord stimulation system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) system.

Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.

The medtech giant also labeled it the world’s smallest and thinnest fully implantable SCS device. Medtronic plans to begin a U.S. market launch in the coming weeks. The system already has availability in Japan and Europe, with CE mark approval coming last August.

“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,” said …

May 2024 edition: Intuitive’s DV5, pediatric device design and diabetes tech

The Intuitive da Vinci 5’s top design changes: ‘This is groundbreaking for robotic surgery’ Small patients, big design challenges: Pediatric device experts guide engineers on solutions The biggest diabetes tech news out of ATTD 2024 5 things that will shape surgical robotics over the next decade All eyes on Intuitive’s da Vinci 5

It’s hard to think of a product update with higher stakes for a device developer — and the medtech industry — than Intuitive Surgical’s da Vinci 5 robotic-assisted surgery system.

All eyes are on the world’s leading surgical robotics developer as it rolls out the next generation of its flagship system after winning FDA clearance. Will the new features and long list of design changes put even more distance between surgical robotics and conventional laparoscopy? Is Intuitive advancing its technology rapidly enough to maintain or expand its lead ahead of larger device manufacturers, maturing surgical robotics developers and fas…

Study highlights benefits of automated insulin delivery for children in UK

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies.

This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas.

The study aimed to assess the efficacy of hybrid closed-loop systems at 12 months. It looked at HbA1c, time in range, hypoglycemia frequency and quality of life measures among children and young people with type 1 diabetes.

Investigators conducted the study between Aug. 1, 2021, and Dec. 10, 2022 across eight pediatric diabetes centers in England. They utilized three automated insulin delivery systems, all fully funded by the NHS:

Tandem t:slim X2 pump with Control IQ technology in combination with the Dexcom G6 CGM. Medtronic MiniMed 780G with Guardian 4. Ypsomed YpsoPump with CamDiab Ca…

Medtronic names new chief regulatory officer

Medtronic Chief Regulatory Officer Yarmela Pavlovic [Photo courtesy of Medtronic]Medtronic (NYSE: MDT) + officials today shared that the medtech giant named Yarmela Pavlovic as its new chief regulatory officer.

Pavlovic posted the news on LinkedIn: “I’m excited to share that I’ve recently been named chief regulatory officer for Medtronic. Medtronic products touch the lives of 74 million patients per year, and I’m honored to continue to support our global mission.”

According to her LinkedIn profile, Pavlovic joined Medtronic as VP of regulatory strategy in July 2021. She held that role until April 2023, when she became VP of global regulatory affairs, strategy and policy. Pavlovic was a partner at law firms Manatt, Phelps & Phillips and Hogan Lovells after starting her career as an attorney at Pepper Hamilton in 2003.

As Medtronic’s chief regulatory officer, Pavlovic will lead regulatory affair…

Medtronic launches next-gen surgical aortic tissue valve

Medtronic (NYSE: MDT) + today announced the launch of its next-generation Avalus Ultra surgical aortic tissue valve.

The medtech giant designed the valve to facilitate ease of use at implant and lifetime patient management. It offers clear visibility for future valve-in-valve procedures and straightforward sizing.

Other features of Avalus Ultra include a low profile and a polyetheretherketone (PEEK) base frame for consistent circularity. Medtronic said it has an industry-leading effective orifice area (EOA) that may allow for greater blood flow. It also features a radiopaque coil for clear visibility for future valve-in-valve procedures.

Avalus Ultra builds on 10 years of clinical experience and long-term durability from the original Avalus valve launched in 2017. The latest-generation valve picked up its own FDA clearance to treat aortic stenosis in January of this year. It offers an option for the surgical aor…

New features of updated Medtronic GI Genius include room for third-party SaMD developers

Medtronic Endoscopy Chief Artificial Intelligence Officer Ha Hong discusses new GI Genius features, design improvements and how other device developers can jump aboard.

Medtronic Endoscopy Chief AI Officer Ha Hong [Photo by Hardy Wilson for Medical Design & Outsourcing]

The latest version of the AI-powered Medtronic GI Genius system for colonoscopy is smarter, more helpful, and has room for third-party apps developed by other devicemakers.

Those third-party software-as-a-medical-device (SaMD) apps “could be anything,” Medtronic Endoscopy Chief Artificial Intelligence Officer Ha Hong said in an interview with Medical Design & Outsourcing.

“The beauty of the GI Genius system is that it’s already been deployed by thousands of hospitals worldwide,” he said. “And as long as the hospital has the system already, the third-party application developers will be able to t…

PTAB upholds two Medtronic patents in spat with Axonics, could go to jury trial

Medtronic (NYSE: MDT) + announced today that the U.S. Patent and Trademark Office upheld claims around two of its patents in its battle with Axonics (Nasdaq:AXNX).

The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of claims in two of Medtronic’s patents in the latest development in a long-running spat between the two companies. It means the PTAB has now upheld the validity of five of the company’s patents at issue in its lawsuit against Axonics.

Medtronic in November 2019 filed a lawsuit against Axonics alleging patent infringements over sacral neuromodulation (SNM) technologies. Since then, the battle has gone back and forth, with the medtech giant most recently asking the U.S. International Trade Commission (ITC) to block the sales of certain Axonics devices.

Medtronic now wants to ask the federal court in the Central District of California to lift its stay on the lawsui…

Health Canada licenses Medtronic Symplicity Spyral renal denervation system

The Medtronic Symplicty Spyral RDN system expands inside the renal arteries. It then ablates nerves in the vessel wall to treat hypertension. [Illustration courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received a license from Health Canada for its Symplicity Spyral renal denervation (RDN) system.

The licensing covers the management of essential hypertension in patients for whomblood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated.

Approval in Canada comes about four months after the company’s landmark FDA approval for Symplicity Spyral in November 2023.

Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure. These nerves can become overactive and contribute to high blood pressure.

After sedat…

Medtronic is raising the bar on outcomes with MiniMed 780G automated insulin delivery system

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]Not long ago, automated insulin delivery technology from Medtronic (NYSE: MDT) + ranked third in the market in terms of patient satisfaction.

That’s according to the Diabetes Patient Voice survey (DQ&A) — a third-party survey that evaluates U.S. diabetes patient satisfaction on a quarterly basis. However, the patient responses were for the previous-generation MiniMed 670G — before the company brought its next-generation MiniMed 780G system to the market.

The current iteration of MiniMed 780G uses the latest Guardian 4 technology and requires no fingersticks while in “SmartGuard” mode. It provides meal detection technology providing automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.

MiniMed 780G with Guardian 4 offers insulin to account…

Avail Medsystems tech sold to robotics startup founded by former Auris leaders

The Avail Medsystems telepresence console beams video, audio and information to laptops and tablets. [Photo courtesy of Avail Medsystems]Medical robotics startup Mendaera has purchased the technology of Avail Medsystems and hired some of its employees, Mendaera co-founder and CEO Josh DeFonzo said in an exclusive interview.

The deal includes “substantially all” of Avail’s assets, said DeFonzo, who offered new details on his company’s objectives as it exits stealth mode.

He declined to disclose financial terms of the deal.

Avail shut down last year for lack of funding. DeFonzo said Mendaera will support customers that were using the existing Avail technology and consoles as its R&D group works on the product roadmap regarding console size and/or features in the coming quarters. However, Avail’s partnership with Medtronic is not part of the transaction, he said.

“We certainly would be happy to work with Medtronic…