Medtronic enrolls first patients in Hugo surgical robot clinical trial

The Hugo robotic surgery system [Image from Medtronic]Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand URO U.S. clinical trial for the Hugo surgical robot.

Dr. Michael R. Abern at Duke University Hospital (Durham, North Carolina) performed the procedure. He used the Hugo robotic-assisted surgery (RAS) system for a robotic-assisted prostatectomy procedure.

“This is an exciting moment,” said Dr. Abern. “Robotic-assisted surgery provides many benefits within my specialty of urology, and I’m proud to have performed the first U.S. clinical trial case with the Medtronic Hugo RAS system.”

Medtronic intended for the use of Hugo in the study across a range of urologic surgical procedures. That includes radical prostatectomy, radical cystectomy, and nephrectomy (partial or radical) procedures at sites in the U.S.

The study, conducted pursuant to an FDA investigational device exemption (IDE), wi…

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The top Medtronic stories of 2022

Medtronic (NYSE: MDT) has had its share of setbacks this year. But the medtech giant has also made moves that could set it up to significantly change how chronic health conditions such as atrial fibrillation are treated.

CEO Geoff Martha has insisted that the world’s largest medical device company can make good on its goals.

Here are the top Medtronic stories on MassDevice that got us to this point.

10. Reduced guidance amid slower procedures and supply recovery

Despite the challenges during the company’s most recent quarter, Martha said the company has businesses where strategy and execution are yielding results.

9. GE Healthcare, Medtronic collaborate in outpatient care space

The partnership centers around the needs and demand for care at ambulatory surgery centers (ASCs) and office-based labs (OBLs).

8. Medtronic Neurovascular goes remote with Avail Medsystems deal

The three-year agreement is worth tens of millions of dollars.

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Health Canada licenses Medtronic extended-wear infusion set for insulin delivery

[Image from Medtronic]Medtronic (NYSE:MDT) Canada announced that Health Canada licensed its Medtronic Extended infusion set for insulin pumps.

The Medtronic Extended Infusion Set represents the first and only infusion set labeled for a wear time of up to seven days. The infusion set for delivering insulin from a pump to the body typically requires changing every two to three days.

Its availability covers customers using MiniMed 600 and 700 series pumps. Medtronic developed it in partnership with Convatec Infusion Care.

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

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Medtronic declares 68¢ quarterly dividend

Medtronic (NYSE:MDT) announced that its board approved a third-quarter cash dividend of 68¢ per ordinary share.

The dividend represents an 8% increase over the prior year. It falls in line with the dividend announcement made by Medtronic in May 2022.

According to a news release, it marks the 45th consecutive year in which Medtronic increased its annual dividend payment. It is payable on Jan. 13, 2023, to shareholders of record at close of business on Dec. 21, 2022.

The company announced the same 68¢ dividend for its second quarter in August.

Shares of MDT rose 0.5% at $78.16 apiece in mid-morning trading today.

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How Medtronic and Avail will accelerate stroke care innovation

Avail Medsystems’ consoles connect neurosurgeons with Medtronic Neurovascular sales reps, commercial teams and stroke experts. [Image courtesy of Avail]

Medtronic Neurovascular and Avail Medsystems have signed an agreement to use Avail’s operating room consoles during stroke procedures, the leaders of both businesses told Medical Design & Outsourcing this week.

Medtronic will pay to place several hundred Avail consoles around the U.S. in the next few years. The deal enables the medtech giant to connect virtually with neurosurgeons, Medtronic Neurovascular President Dan Volz said in an interview. (Read more details of the deal at our sister publication MassDevice.)

Avail’s consoles provide live-streaming video, audio and imaging data between surgeons in operating rooms and experts elsewhere. They can watch on a laptop or tablet and offer real-time feedback.

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Medtronic Neurovascular goes remote with Avail Medsystems deal

Avail Medsystems’ consoles connect neurosurgeons with Medtronic Neurovascular sales reps, commercial teams and stroke experts. [Image courtesy of Avail]Medtronic (NYSE:MDT) Neurovascular will pay to use hundreds of Avail Medsystems consoles in operating rooms across the country under a first-of-its-kind deal, leaders of both businesses told MassDevice this week.

The Medtronic unit will use Avail’s operating room telepresence technology to connect virtually with neurosurgeons and other care providers as they treat stroke patients, Medtronic Neurovascular President Dan Volz said in an interview. The deal covers several hundred Avail consoles, he said.

Avail Medsystems’ consoles send video, audio and imaging data to remote users of the Avail app on laptops and tablets. [Image courtesy of Avail]Additionally, the consoles will let surgeons confer with other physicians and experts over the system. Avail’s system offers two-way visual, audio and data…
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Medtronic completes enrollment in pulsed-field ablation catheter trial

Medtronic’s Sphere-9 mapping and ablation catheter [Photo courtesy of Medtronic]Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera’s pulsed-field ablation catheter tech.

The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and navigation platform, it treats atrial fibrillation.

Affera designed the technology to diagnose, map and treat heart arrhythmias with ablation. It scars heart tissue to interrupt errant signals using both radiofrequency ablation and non-thermal pulsed-field ablation technology. Medtronic acquired the company for $1 billion in August.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Medtronic begins distributing Acutus AcQCross sheath-compatible septal crossing devices

[Image from the Acutus Medical website]Acutus Medical (Nasdaq:AFIB) announced today that Medtronic (NYSE:MDT) intends to begin distributing its left-heart access devices.

In April, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million. That portfolio includes the AcQCross line of sheath-compatible septal crossing devices. It also features the AcQGuide Mini, AcQGuide Flex and AcQGuide VUE technologies.

Acutus said in June that it completed the first two closings of its deal to sell the devices to Medtronic. Last month, Acutus completed the first $20 million milestone under its asset purchase agreement with the medtech giant.

Beginning today, Medtronic intends to initiate distributing the products, having provided notice to Acutus of its intentions. Pursuant to the distribution agreement, Acutus ceased all distribution and sales of the left-heart devices to third parties, according to a news release. It now intends to manufacture …

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Medtronic warns on HeartWare HVAD again

Medtronic’s HVAD [Image courtesy of Medtronic]Medtronic (NYSE:MDT) recently issued an urgent medical device correction due to potential issues with the HeartWare HVAD.

The notice alerts healthcare professionals to safety information related to the controller driveline cover of the HeartWare ventricular assist device (HVAD). Over time, the driveline cover may become hardened. This could create difficulty or the inability to slide the cover back to access the driveline controller connector.

Delayed access to the connector may result in patient harm from a prolonged pump stop, according to the notice. Medtronic attributed the issue to plasticizer loss, which environmental factors may accelerate. Plasticizer keeps the driveline cover material soft and malleable.

Medtronic received 33 complaints of a hardened and/or stuck driveline cover between Jan. 3, 2017, and Sept. 15, 2022. The issue occurred after multiple years of use in the observed complaints. In …

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Medtronic reports positive study results for next-gen Evolut FX TAVR system

The Evolut FX TAVR system. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today presented positive results for its next-generation transcatheter aortic valve replacement (TAVR) system.

The study compared the next-generation Evolut FX TAVR systems to earlier-generation Evolut systems. Data demonstrated significantly improved commissure alignment during TAVR procedures with Evolut FX.

A late-breaking presentation at PCR London Valves 2022 summarized the early limited market release of Evolut FX. The FDA approved the Evolut FX in August 2021. The study included data from 168 patients across six U.S. centers. It compared that data to outcomes for 378 Evolut PRO+ patients from a single center.

Medtronic said in a news release that commissure alignment represents a key aspect of TAVR procedures. It could provide easier future coronary access and improved coronary blood flow. It may also improve valve hemodynamic performance and facilitate redo-TAVR in the futu…

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Medtronic reduces guidance amid slower procedures and supply recovery

Medtronic (NYSE:MDT) today reported second-quarter financial results that beat Wall Street expectations on earnings but missed on revenue.

In addition, the world’s largest medical device company reduced its guidance for the rest of the year amid slower market procedure volume recovery in some markets. While it worked through its most acute supply chain challenges, Medtronic resolved the problems later than expected in the quarter.

Investors reacted by sending MDT shares down more than 5% to $78.15 apiece in premarket trading.

Medtronic earned $427 million, or 32¢ per share, off $7.585 billion for the quarter ended Oct. 28. 2022. The bottom line was down 67%, and the top line was down 3% compared with Q2 2021.

Adjusted to exclude one-time items, Medtronic saw EPS of $1.30. The results were 2¢ ahead of The Street, where analysts expected adjusted EPS of $1.28 and $7.7 billion in revenue.

“Slower than predicted procedure and supply…

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Why are so many medical device companies making big investments in Ireland?

[Image from Ainars Djatlevskis on Unsplash] The foreign direct investment agency for Ireland has some of the biggest names in medtech investing in the country.

Within recent years, a number of major medtech companies celebrated anniversaries. Abbott’s was 70 years, Medtronic’s was 40 and Boston Scientific’s was 25.

That’s how long those companies have operated in Ireland.

Gerard Kilcommins, Medtronic VP of global manufacturing, vascular therapies and implants and country director in Ireland, said in a report earlier this year that its 40-year anniversary represents “an important milestone” in the company’s history.

“Our sites in Ireland have played a significant role in Medtronic’s evolution from medical device manufacturer to a global leader in healthcare technology,” Kilcommins said in July.

Each of those three companies, plus many more big names in medtech, choose Ireland for a broad range of inve…

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