Abbott Archives - Medical Design Sourcing

Abbott has a new Vascular division CMO

New Abbott Vascular Chief Medical Officer Dr. Ethan Korngold. [Image from Ethan Korngold on LinkedIn]Abbott (NYSE: ABT) + has appointed Dr. Ethan Korngold as its new divisional VP of medical affairs and chief medical officer for its Vascular business.

Korngold succeeds Dr. Nick West, who spent four years as CMO and divisional VP of global medical affairs at Abbott Vascular. West departed in September to become associate chief medical officer at Shockwave Medical, which Johnson & Johnson is now acquiring.

The new CMO joins Abbott with more than 20 years of medical practice. He most recently served as medical director of interventional cardiology and structural heart at the Providence Heart and Vascular Institute. According to LinkedIn, he spent eight years at Harvard Medical School and Massachusetts General Hospital.

Julie Tyler, Abbott SVP and president of the Vascular unit, welcomed Korngold in a LinkedIn post…

Abbott wins FDA approval for dissolving drug-eluting scaffold

The Esprit everolimus-eluting scaffold. [Image from the Abbott website]Abbott (NYSE: ABT) + announced today that the FDA approved its Esprit everolimus-eluting resorbable scaffold system.

The Esprit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving.

Abbott says that before this approval, there were no stents or drug-coated balloons to treat below-the-knee chronic limb-threatening ischemia in the U.S.

The current standard of care, balloon angioplasty, relies on a small balloon delivered via a catheter. It compresses against the arterial wall, opening the blood vessel and restoring flow.

However, Abbott said blockages treated only with this method have poor short- and long-term results. Many cases result in the vessels becoming blocked again, requiring additional…

Report: Abbott files trio of patent lawsuits over CGM tech in Europe

The FreeStyle Libre 3 continuous glucose monitor. [Image courtesy of Abbott]Abbott (NYSE:ABT) filed three patent lawsuits against SiBionics and its distribution partner in Europe, JUVE-Patent reports.

The lawsuits include patent infringement allegations centered around continuous glucose monitoring (CGM) devices, according to the report. Abbott filed them against China-based SiBionics and its sales partner Umedwings at the Unified Patent Court.

SiBionics develops, manufactures and distributes CGM and other monitoring technologies. It received CE mark approval for its GS1 continuous glucose monitoring (CGM) system last fall. Umedwings, a Dutch company, serves as its distribution partner in Europe.

Get the full story at our sister site, Drug Delivery Business News.

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…

Non-insulin, basal CGM use exceeds analysts’ expectations, Dexcom and Abbott to benefit

Left, the Dexcom G7. Right, the Abbott FreeStyle Libre 2. [Images from Dexcom and Abbott]William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations.

Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management.

Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle Libre 3). Dexcom also began rolling out its Stelo over-the-counter non-insulin CGM and Abbott has its Lingo non-insulin biowearable coming to the U.S. soon.

According to Kaczor, the number of non-insulin patient adds in 2023 proved surprising and came in above expectations. William Blair estimates nearly 300,000 new non-insulin CGM users, compared to a projection of 200,000. She sees this as an additive to the still-underpenetrated opportunity in the insulin-using diabetic patient population. Read more

The biggest diabetes tech news out of ATTD 2024

This is a screenshot from a video demonstrating the features of the new Roche Accu-Chek SmartGuide CGM at ATTD 2024.

Every year, the diabetes community comes together for the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).

In the 17th installment at the start of this month, some of the biggest names shared new studies and technologies set to advance the diabetes space. Dexcom, Abbott, Medtronic and more contributed on their end, while some new technologies are coming to the fore as well.

Here are the biggest stories from this year’s ATTD conference in Florence, Italy. (You can also check out the biggest news out of ATTD in 2023 and 2022.)

Dexcom’s direct-to-watch feature

Dexcom announced at ATTD that it introduced a direct-to-Apple-Watch feature for its G7 continuous glucose monitor (CGM) users.

The company plans a phased launch for all G7 iOS users everywhere by the end of the second quarter of …

Abbott is launching its latest Navitor TAVI system in the U.S.

A screengrab of the Navitor Vision TAVI system from an Abbott video on LinkedIn. [Image from Chris Waddell on LinkedIn]Abbott (NYSE: ABT) + is launching the latest generation of its Navitor heart valve technology in the U.S., according to one company official.

In a post on LinkedIn, Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), shared the news of the launch. The latest version — called the Navitor Vision — features a range of enhancements compared to the previous version.

“I’m excited to share Abbott is launching the latest generation of Navitor in the U.S.-Navitor Vision,” Waddell wrote in the post. “Abbott is going big in TAVI!”

Waddell shared that the features include stable and precise delivery, excellent hemodynamics and low paravalvular leak (PVL) rates. Abbott built the system upon a proven, durable platform with a future-ready design,…

Recall of Abbott HeartMate comms system is Class I

The HeartMate 3 LVAD. [Image courtesy of Abbott]The FDA deemed a recall of the Abbott (NYSE: ABT) + HeartMate Touch Communication System Class I, the most serious kind of recall.

Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero deaths related to this recall.

In total, the recall affects 1,560 devices in the U.S. distributed between May 7, 2020, and Dec. 18, 2023. Abbott initiated the recall on Jan. 3, 2024.

The HeartMate Touch Communication system monitors patients who have an implantable HeartMate 3 left ventricular assist device (LVAD). Abbott has previously reported that HeartMate 3 can extend the lives of advanced heart failure patients by at least five years.

HeartMate’s communications system works with a controller and includes a tablet…

MDO wins ASBPE awards for medtech coverage, data journalism and DEI

Medical Design & Outsourcing won regional Azbee awards for these 2023 cover stories.

Medical Design & Outsourcing and members of our team have once again won honors in the annual American Society of Business Publication Editors (ASBPE) Awards of Excellence competition.

The ASBPE Awards of Excellence, also called the Azbee Awards, recognize the highest quality reporting, editing and design in business-to-business, trade, association and professional publications.

Medical Design & Outsourcing won four regional awards in the Heartland region, which covers the Cleveland, Ohio headquarters of our owner. ASBPE will reveal whether they are gold, silver or bronze awards in April or May.

Additionally, ASBPE will name national gold, silver, bronze and Overall Excellence finalists on April 18. Medical Design & Outsourcing won four national and Overall Excellence honors from ASBPE in 2023.…

Abbott reports data that backs TAVR, LAA systems

The Amplatzer Amulet LAAO device. [Image courtesy of Abbott]Abbott (NYSE: ABT) + today reported positive study data supporting its first-generation transcatheter aortic valve system and its Amplatzer Amulet.

Abbott reported its outcomes at the Cardiovascular Research Technologies (CRT) 2024 meeting.

The company first reported a pooled analysis from three clinical studies evaluating its Portico TAVR system, the predecessor to Navitor. It showed the safety and effectiveness of Portico for severe, symptomatic aortic stenosis in patients at high and extreme surgical risk through five years.

Abbott reported excellent sustained blood flow and prevention of paravalvular leaks (PVLs) with Portico. It also reported favorable clinical event rates at a high rate of accurate valve matching due to the wide range of annulus size.

The company also had data on the Navitor system, which maintained safety and effectiveness th…

Real-world data backs Abbott FreeStyle Libre CGM in tandem with GLP-1s

The FreeStyle Libre 3 continuous glucose monitor. [Image courtesy of Abbott]Abbott (NYSE: ABT) + today announced data from two real-world studies highlighting the success of its CGM when used with GLP-1 drugs.

Data showed that people with type 2 diabetes using GLP-1s with FreeStyle Libre had a greater improvement in HbA1c compared to GLP-1s alone. Abbott presented the findings at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy.

GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and weight loss. This therapeutic class, a glucagon-like peptide 1, has proven to lead to improved blood sugar control and weight loss. The drug class continues to grow in popularity with prescriptions for type 2 diabetes increasing.

Last year, BTIG analysts spoke with an expert, determining the potential impact of GLP-1s on the diabetes market. Not long after, Abbott s…

March 2024: Medtronic AI, Ortho tech at AAOS 2024 and Abbott PFA

How Medtronic’s using AI: Artificial intelligence insights and advice Abbott bets on balloons in the pulsed field ablation battle How Noah Medical’s robotic Galaxy system goes deep into the lungs The biggest stories from AAOS 2024 Surgical robots don’t improve knee surgery revision rates, study says Seize the AI opportunity

Less than a year into his new role as Medtronic’s chief technology and innovation officer, Ken Washington was presenting on artificial intelligence to leaders of the company’s operating units.

One of the GMs stopped him and asked for help making sense of all the buzzwords and acronyms.

Perhaps you know the feeling. It’s hard to grasp how AI seems to be everywhere, with advanced computing power making sense of vast datasets. It’s in the voice assistants on our smartphones, the streaming services on our various screens, mapping systems in our cars, the chat bots who respond when we need customer service, and online services ra…