Medtronic beats The Street in Q4, Hugo robot wins IDE

Medtronic (NYSE:MDT) had much to tout with its pipeline as it released Street-beating fourth-quarter results.

CEO Geoff Martha announced to analysts that FDA has granted the company’s much-anticipated Hugo robot an investigational device exemption approval.

Medtronic is preparing to commence its Expand Uro trial in the U.S. to study Hugo in urologic procedures, Martha said during today’s earnings call, transcribed by Seeking Alpha.

Meanwhile, renal denervation appears to be back as a promising treatment for hypertension. Medtronic expects to release its On Med pivotal trial results later this year, likely at the TCT Conference in November. Martha thinks the results are “likely to be one of the most highly anticipated events in medtech this year.”

CFO Karen Parkhill added: “Two of our largest opportunities are surgical robotics and renal denervation. We’re purposely making significant investments in them to ensur…

Read more
  • 0

Medtronic wins CE mark for smart insulin pen, CGM system

Medtronic (NYSE:MDT) announced today that it received CE mark approvals for its InPen smart insulin pen and its Guardian 4 sensor.

Fridley, Minn.-based Medtronic’s new European approvals cover expanded functionality of the InPen for multiple daily injections (MDI), along with approval for the Guardian 4 sensor that requires no fingersticks for calibration or diabetes treatment decisions, according to a news release.

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

Read more
  • 0

Barclays is bullish on medtech

Barclays analysis projects that medtech might be on its way to a stretch of “outperformance” even in the wake of the COVID-19 pandemic.

According to SeekingAlpha, the report cited eight reasons that make the investment bank bullish on the industry in the coming years, starting with what it calls “robust innovation.”

On top of the evolving innovation in medtech, Barclays expects the canceled procedures of 2020 (as a result of COVID-19) to return, while new technology could increase diagnoses.

Direct-to-consumer advertising, a potential return to “normality” in a post-pandemic scape, surveys indicating a resurgence in elective surgeries, healthy balance sheets and an aging population as a tailwind round out the reasons why Barclays expects success for medtech over the next several years.

Medtech companies that Barclays stands “overweight on” include Abbott (26.72% upside), Boston Scientific (18.55% ups…

Read more
  • 0

DTW Podcast: How AtriCure built a big business in Afib; A deep look into Abbott’s new Coronary imaging platform

In this week’s episode of the DeviceTalks Weekly Podcast, Dr. Nick West, CMO & divisional VP of global medical affairs at Abbott’s vascular business, discusses the European launch of the company’s new coronary imaging platform.

Dr. West explains how the AI-powered platform works and the benefits it offers for decision-making during coronary stenting procedures. He also delves into the AI-based technology behind the platform and the direction both imaging and medtech as a whole are heading with AI.

In our second interview, Mike Carrel, CEO and president of AtriCure, explains how the company became a force focusing on the atrial fibrillation (Afib) and left atrial appendage (LAA) markets.

Carrel walks listeners through the company’s efforts to expand its reach into the connected pain management market. But then he makes a strong case building out its Afib pipeline which includes the EPi-Sense System, which in April received FDA approval to treat …

Read more
  • 0

DTW Podcast: How AtriCure built a big business in Afib; A deep look into Abbott’s new Coronary imaging platform

In this week’s episode of the DeviceTalks Weekly Podcast, Dr. Nick West, CMO & divisional VP of global medical affairs at Abbott’s vascular business, discusses the European launch of the company’s new coronary imaging platform.

Dr. West explains how the AI-powered platform works and the benefits it offers for decision-making during coronary stenting procedures. He also delves into the AI-based technology behind the platform and the direction both imaging and medtech as a whole are heading with AI.

In our second interview, Mike Carrel, CEO and president of AtriCure, explains how the company became a force focusing on the atrial fibrillation (Afib) and left atrial appendage (LAA) markets.

Carrel walks listeners through the company’s efforts to expand its reach into the connected pain management market. But then he makes a strong case building out its Afib pipeline which includes the EPi-Sense System, which in April received FDA approval to treat…

Read more
  • 0

MedtronicTalks Podcast: Giovanni Di Napoli, president of gastrointestinal, discusses broader pipeline, big opportunity

Giovanni Di Napoli, president of Medtronic’s gastrointestinal business

In this episode of the MedtronicTalks podcast, Giovanni Di Napoli, president of Medtronic’s gastrointestinal business, says his move to medtech wasn’t an easy decision.

He was seeing great success coaching professional basketball in Italy, but he saw a career in medtech as a new opportunity to win.

Today, he leads Medtronic’s gastrointestinal business, which hadn’t been seen as a significant player in the space until the merger with Covidien. Now, Medtronic is introducing new diagnostic and imaging equipment to make early diagnosis of colon cancer and other serious ailments easier for patients.

“The portfolio we built in the last three years is very solid. It’s very innovative,” Di Napoli said. “I know I’m biased, but if you talk to [gastroenterologists] across the globe, now they see Medtronic being the most innovative company in …

Read more
  • 0

Evolut TAVR just as good as open-heart surgery among younger people, Medtronic says

Medtronic’s CoreValve Evolut TAVR [Image from Medtronic]Medtronic (NYSE:MDT) today touted two-year outcomes for a trial comparing its Evolut TAVR system to open-heart surgery in younger people.

Fridley, Minn.-based Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system went up against the gold standard of open-heart surgery in younger, healthier aortic stenosis patients in the trial, which had its results presented as a late-breaking clinical trial at the EuroPCR 2021 e-Course, according to a news release.

Results of the landmark Evolut Low-Risk Trial showed that Evolut TAVR was non-inferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at two years (4.3% in TAVR against 6.3% in surgery). It also trended the same or lower on all critical events observed in the study.

“We know that TAVR has an advantage over surgery in certain near-term outcomes; however, in these low-risk studies, longer te…

Read more
  • 0

Is renal denervation back as a high blood pressure treatment?

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today reported clinically significant and sustained blood pressure reduction among nearly 3,000 people with uncontrolled hypertension treated with the company’s Symplicity renal denervation system.

The study results, reported today out of the 2021 EuroPCR Annual Meeting, come the same week as ReCor Medical touted its own positive renal denervation study at the American College of Cardiology’s 70th Annual Scientific Session.

Together, the new research suggests that renal denervation could be back as a promising medical technology in the cardiovascular space — half a decade after Medtronic announced a major clinical trial had failed to meet its efficacy endpoint. Since the Symplicity HTN-3 study’s failure, Medtronic has sought trial designs that clear up confounding factors su…

Read more
  • 0

Is renal denervation back as a high blood pressure treatment?

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) today reported clinically significant and sustained blood pressure reduction among nearly 3,000 people with uncontrolled hypertension treated with the company’s Symplicity renal denervation system.

The study results, reported today out of the 2021 EuroPCR Annual Meeting, come the same week as ReCor Medical touted its own positive renal denervation study at the American College of Cardiology’s 70th Annual Scientific Session.

Together, the new research suggests that renal denervation could be back as a promising medical technology in the cardiovascular space — half a decade after Medtronic announced a major clinical trial had failed to meet its efficacy endpoint. Since the Symplicity HTN-3 study’s failure, Medtronic…

Read more
  • 0

5 of the latest cardiac tech insights out of ACC.21

The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech.

Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology showed significant progress in reducing high blood pressure.

Get the full story on our sister site, Medical Design & Outsourcing.

Read more
  • 0

ReCor Medical has positive renal denervation study news

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, renal denervation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint.

Get the full story on our sister site MassDevice. 

Read more
  • 0

ReCor Medical has positive renal denervation study news

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, renal denervation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint.

Medtronic, though, has since sought trial designs that…

Read more
  • 0