FDA committee to examine safety of endovascular stent grafts

AFX Endovascular AAA system [Image courtesy of Endologix]FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies.

Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood leakage called Type III endoleaks. Endologix has found itself having to vigorously defend itself against studies claiming a problem.

The FDA is presently advising that anyone with any Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) visits a doctor at least once a year to get checked for leaks.

Another Endologix product — the Ovation iX abdominal stent graft system — was the subject of a Class I recall last year including five deaths, though Endologix clarified that two of the five deaths took place follo…

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DTW Podcast – CEO MacMillan on how COVID-19 strengthened Hologic

Hologic CEO Steve MacMillan says in early March 2020 he didn’t appreciate how COVID-19 would change the world forever. But the diagnostics company quickly rose to the challenge, becoming one of the surer suppliers of diagnostic tests needed to chart the Coronavirus’ severity.

In this DeviceTalks Weekly Podcast, MacMillan shares how Hologic pivoted to meet the calls for help from political leaders in the US and around the world.

He also shares what’s next for the company which has shed its aesthetics business in favor of a tighter new course, a course that includes the creation of an innovative information index that will yield new data on women’s health.

While Hologic rose to the challenge during the pandemic, GuardianLane is ready to help children who are coping with grief, including the loss of loved ones to COVID-19 and other diseases.

CEO Kristina Jones shares the story that won the first pitch contest held by Medtech Color, an organization fo…

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FDA approves Medtronic’s Harmony transcatheter pulmonary valve system

FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease.

The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device could also potentially reduce the number of open-heart surgeries needed over a person’s lifetime.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease,” said Dr. Bram Zuckerman, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.

“It offers a less-invasive treatment alternative to open-heart surgery to patients with a leaky native or surgically-repaired RVOT and may help patients improve their quality of life and return to …

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How 5G could affect medtech

The latest standard of broadband technology continues to make waves in 2021. But what about medtech?


Cellphone using 5G

Cellphone using 5G (Imagy by Frederik Lipfert on Unsplash)

Wireless tech companies such as Qualcomm are predicting download speeds as high as 10 gigabits per second as next-generation 5G cellular networks roll out worldwide.

The open question in medtech is how quickly companies will take advantage of the super-speedy connectivity for their own products.

“5G is about bringing more capacity and speed to the pipes,” said Don Jones, a member of the advisory council at BrightInsight and a veteran of the digital healthcare space. Jones spent more than 11 years building Qualcomm’s healthcare group.

“What you have to analyze is, ‘Can healthcare take advantage of what essentially amounts to these bigger pipes?’ Because more data can be shoved through them with m…

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Medtronic recalls oxygenator used for cardiopulmonary bypass among kids

Image from Medtronic/FDA

The FDA has issued a Class I recall for the Medtronic Affinity Pixie oxygenator and cardiotomy/venous reservoir with Balance biosurface.

Medtronic’s Affinity Pixie system with Balance biosurface is designed for treating newborns, infants and small pediatric patients requiring cardiopulmonary bypass. The system adds oxygen to the blood and removes carbon dioxide, while the venous reservoir supports and improves blood circulation during cardiopulmonary bypass.

According to an FDA notice, Medtronic is recalling the Affinity Pixie with Balance biosurface due to potentially elevated levels of harmful bacteria called endotoxins. Using the device with high levels of endotoxins could result in fever, infection, acute systemic toxic reaction or death, although there have been no complaints or reports of injuries or deaths related to the issue.

The recall affects devices distributed between April 29, 2020, and Nov. 20, 2020. Medtroni…

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DTW Podcast: McEvoy gives edge to J&J’s second-mover strategy in digital surgery

Johnson & Johnson may have left the gate than some digital surgery competitors but Ashley McEvoy, executive vice president, worldwide chairman, medical devices, says the company has the technology and the team to win the race.

In an interview with DeviceTalks Weekly Podcast, McEvoy said robotic and digital surgery systems currently on the market have only been adopted by a small percentage of providers, leaving the field open for new competitors like J&J.

“Surgery is a slow adoption business,” McEvoy said,

While offering “huge respect” for the first movers. McEvoy said J&J enjoys market leadership right now in surgery. Its size and reach will open doors for its three digital surgery systems – Velys, Monarch and Ottava.

“We’re going to have a differentiated value proposition doing so in a broad-based healthcare, J&J fashion, not just like a standalone med tech company,” she said.

McEvoy pointed to the team J&J as as…

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Medtronic wins CE mark approval for DBS directional lead system

Medtronic (NYSE: MDT) today announced that it received CE mark approval for its SenSight directional lead system for deep brain stimulation therapy.

SenSight works seamlessly with certain Medtronic neurostimulators including the Percept PC neurostimulator. It enhances the detection of local field potentials and has directional stimulation for individualized and patient-specific data with additional programming features to personalize therapy.

“This is the only directional lead with built-in sensing capabilities,” Jens Volkmann, chairman and professor of neurology in the University Clinic of Würzburg, said in a news release. “The challenge of DBS is to provide stimulation to a very small brain region only at times, when fluctuating symptoms require treatment. This new technology holds promise for a truly personalized therapy, which we can adapt using the objective data from each patient to inform programming in ‘space and time.'” Read more

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MedTech 100 roundup: Small dip keeps industry down

The last month brought a bit of a skid for the medtech industry and after a slight rebound last week, the downward trend has returned.

A strong start to 2021 came to an end in late February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had only notched an all-time best of 110.96 on Feb. 15, leading to a fall at a level not seen since October.

While February’s highs have not yet been returned to, the industry showed signs of bouncing back last week (March 12) by finishing at 104.62.

Despite ticking up as high as 105.71 on Monday, March 15, the index regressed to the mark set the week prior, then dipped even further to end the week, coming in at 104.05 on March 19, marking a -0.5% drop week-over-week.

However, the industry remains in a better spot than it was at this time a year ago, as the index is now 12.7% up on the pre-COVID-19 pandemic high of 92.32 set on Feb. 19, 2020.<…

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J&J leader McEvoy lays out future for medtech giant; Stryker’s Murray talks 3Dprinting

J&J’s Ashley McEvoy talks COVID-19, Digital Surgery, Innovation and the future of Vision Care.

In this week’s DeviceTalks Weekly Podcast, the 50th of the series, Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson, makes her DeviceTalks Weekly debut.

In this update, McEvoy delivers great insights on several areas of interest including:

COVID-19’s impact on J&J in the past, and what changes may remain in the future. J&J’s far-ranging digital surgery portfolio could bolster many of its specialties. How the company uses its innovation network to accelerate development Why she’s bullish on the future of eye care. How the company will prepare for future challenges.

We also talk with Naomi Murray, Director of Advanced Operations-Additive Technology at Stryker about her almost predestined path to join the orthopedics leader.

She’ll be leading the March 23 discuss…

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Medtronic: 3 things investors might be overlooking

Following recent virtual investor meetings with Medtronic executives, analysts have identified a handful of important things investors should know.

Truist analysts cited the medtech giant’s recent steps to change the direction of the company as it develops its pipeline, which includes a close-to-launch Hugo robotic surgery system. The analysts stand firm on their opinion that investors should be buying MDT shares, but there are some key points regarding why.

Market share growth

According to the analysis, since CEO Geoff Martha took over for Omar Ishrak close to one year ago, the company’s focus has been centered on market share growth.

Martha told the analysts that the company’s newly implemented operating model is designed to reduce the layers of decision-making, separating into 20 “empowered operating units,” or segments that are given control they didn’t have before.

He suggested that employee morale is high and internal surve…

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New FDA-approved labeling touts Medtronic Intellis’ ability to relieve back pain

Medtronic (NYSE: MDT) announced today that FDA has approved revised commercial labeling that touts superior back pain relief for its Intellis spinal cord stimulation platform.

Intellis uses differential target multiplexed (DTM) programming, which Medtronic describes as a unique and proprietary programming option based on years of preclinical research. Recent study outcomes from a multicenter randomized control trial found DTM SCS produced improved results over conventional SCS, according to Medtronic.

At 3 months, 81% of patients treated with DTM SCS reported their back pain was at least halved, compared with 51% of patients treated with conventional SCS. The study used the Visual Analog Scale (VAS), a widely used and accepted measure for pain intensity.

The new labeling update follows the most recent 12-month clinical trial outcomes, reported during a late-breaking clinical trial session at NANS 2021. The trial found superior back pain relief with DTM S…

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Medtronic must face pain-pump lawsuit

Medtronic’s SynchroMed II infusion pump (Image courtesy of Medtronic)

A 70-year-old man may proceed with a lawsuit claiming that Medtronic’s SynchroMed II infusion pump is defective and that the company was negligent in manufacturing it.

A U.S. District Court judge in West Virginia last week denied Medtronic’s motion to dismiss the lawsuit brought by John David Brumfield, who claims that the pump in the SynchroMed II device he had implanted in 2012 to treat back pain stopped delivering the pain medication hydromorphone in 2018.

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

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