Medtronic acquires Medicrea and its spinal surgery tech

Medtronic (NYSE:MDT) today said it acquired France-based spinal surgery technology company Medicrea.

Through the deal, Medtronic is buying for a tender offer price of €7.00 (nearly $7.84) per share for a premium of 22% over the closing price of shares on July 14, 33% over the one-month value-weighted average price and 56% over the three-month volume-weighted average price.

The acquisition will help strengthen Medtronic’s orthopedic spine surgery platforms.

“Combining Medtronic’s innovative portfolio of spine implants, robotics, navigation, and 3D imaging technology with Medicrea’s capabilities and solutions in data analytics, artificial intelligence and personalized implants, would enhance Medtronic’s fully-integrated procedural solution for surgical planning and delivery. This marks another important step in furthering our commitment to improving outcomes in spine care,” said Jacob Paul, SVP of cranial and spinal technologies at Medtronic.

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Titan Medical CEO sees opportunity as product development resumes

Titan Medical (TSX:TMD;OTC:TITFX) has been able to resume product development of its single-port robotic surgical system, CEO David McNally said today in a letter to shareholders.

Titan is back working on its system thanks to a $10 million license payment and $1.5 million loan as part of its new development deal with Medtronic (NYSE:MDT). Titan also recently brought in $20 million from a public equity raise.

McNally said that the opportunity for single-port robotic surgery appears promising. He noted the clinical success that surgeons are reporting while using Intuitive Surgical’s da Vinci SP — presently the only commercially available single-port offering — but the success involves surgical indications outside the initial target area that Titan is pursuing.

“We believe that our robotic-assisted surgical system, having been designed with a focus on single-port surgery, may provide competitive advantages for physicians and their clinical teams, hosp…

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MedTech 100 roundup: Medtech stocks bump along

Medical device company stocks appear to be in a holding pattern as investors wait for new earnings reports.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — bumped along last week. It closed at 84.39, about where it had been at the start of the week. The Dow Jones Industrial Average and S&P 500 performed similarly.

The Index as of the end of last week was up 35.8% from 62.13 on March 23 — its lowest point so far during the pandemic. It’s still down –8.6% from its pre-pandemic-crash high point of 92.32 on Feb. 19.

The MedTech 100 Index started today with an uptick but then ended about where it started — even as tech stocks powered the DJIA up 1%.

Investors, for now, appear to have already absorbed worries about the surge in new COVID-19 cases in the South and elsewhere in the United States. Expect more clarity from the markets when the next round of quarterly earnings comes out later…

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Medtronic, Tandem Diabetes Care bury the hatchet on potential IP disputes

Two major insulin pump makers — Medtronic (NYSE:MDT) and Tandem Diabetes Care (NSDQ:TNDM) — announced today that they’ve inked a non-exclusive patent cross-license agreement related to diabetes treatment tech.

The companies said the agreement will allow them to focus on innovation while avoiding the distraction of potential legal disagreements.

The deal could be but another example of how medical device companies are trying to avoid unnecessary costs — including potentially money-draining litigation and IP cases — amid the COVID-19 pandemic and resulting recession.

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

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Report: Medtronic makes a bid for Intersect ENT

Intersect ENT (NSDQ:XENT) shares soared today on news that Medtronic (NYSE:MDT) has made a bid for the Menlo Park, Calif.-based ear, nose and throat condition treatment developer.

Bloomberg reported the transaction late Tuesday, attributing the news to “people with knowledge of the matter.” Traders sent Intersect ENT shares up 38% in premarket trading. Medtronic declined to comment.

Intersect reported a first-quarter 2020 loss of -$17.53 million in May, compared with a -$10.8 million loss for the same period of 2019. President & CEO Thomas West attributed the loss to the reduction in elective sinus surgeries during the COVID-19 pandemic.

Intersect said in February that it expected sales of $115 to $119 million in fiscal 2020, but withdrew that guidance in April and announced cost-cutting plans in May. Those cuts included worker furloughs and layoffs, a hiring freeze, suspension of near-term production and delaying clinical research projec…

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Medtronic Linq II insertable cardiac monitor gets OK in U.S., Europe

Medtronic Linq II insertable cardiac monitor [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) announced today that its Linq II insertable cardiac monitor has received FDA clearance in the U.S., as well as a CE Mark in the EU.

The Linq II boasts remote programming. That means a person with the Linq II implanted inside of them doesn’t need to return to the doctor’s office or hospital to get the device’s settings changed. About a third of the size of a AAA battery, the Linq II also has improved device longevity — 4.5 years — with accuracy enhancements for better detection of abnormal heart rhythms.

“In the current COVID-19 environment, the Linq II system offers patients a seamless way to experience ongoing connectivity between their device and their physician, while reducing the need for in-office visits,” said Dr. Rob Kowal, chief medical officer of the Medtronic’s Cardiac Rhythm a…

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CVRx’s Yared speaks to the value of confidence and cooperation

Nadim Yared, CEO of CVRx

This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure.

The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology.

In this week’s DeviceTalks Weekly podcast, CEO Nadim Yared walks us through the negotiations the company went through with the FDA to get to this point.

Yared, the prior chairman of the industry group AdvaMed, also shares the story of his career, which started early on when he secured a job at GE even before graduating college.

In this talk, Yared speaks to several issues including:

The power of confidence and the dangers of overconfidence when building a career. How he decided to take the job at CVRx (and why he didn’t initially want to talk abo…
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Axonics’ SNM system wins FDA nod for 3T-MRI scans

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it has won FDA approval for full-body 3 Tesla (T) MRI scanning for patients implanted with its r-SNM sacral neuromodulation system.

The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental approval for 3T scans, the Axonics device continues to be the only SNM system available in the U.S. that is MRI-compatible for both 1.5T and 3T full-body scans, according to the company.

Axonics’ r-SNM system won FDA pre-market approval in November for the treatment of overactive bladder and urinary retention, which followed the FDA approval that r-SNM won in September for fecal incontinence.

The implantable, rechargeable sacral neuromodulation device is touted as the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM de…

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Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.

The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination.

[Image courtesy of Mayo Clinic]

As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier this year.

While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the benefit of seeing how hospitals in the Upper Midwest and the Northeast managed the pandemic.

One of the easiest — or at least most evident — lessons available is the use of additive manufacturing or 3D printing. Mayo Clinic and other hospital systems, including Beth Israel Lahey in Boston, used their 3D printers to produce critical personal protective equipment (PPE) such as masks and face shiel…

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Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.

The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination.

[Image courtesy of Mayo Clinic]

As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier this year.

While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the benefit of seeing how hospitals in the Upper Midwest and the Northeast managed the pandemic.

One of the easiest — or at least most evident — lessons available is the use of additive manufacturing or 3D printing. Mayo Clinic and other hospital systems, including Beth Israel Lahey in Boston, used their 3D printers to produce critical personal protective equipment (PPE) such as masks and face shiel…

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What is a medical ventilator and how does it work?

Image from Ventec Life Systems

The ventilator has come to the fore as a vital piece of equipment during the COVID-19 pandemic.

Put simply, ventilators exist to help patients who can’t breathe, breathe. The novel coronavirus’ attack on the respiratory system brought ventilators into the spotlight, forcing the U.S. to turn to its strategic national stockpile as manufacturers scrambled to scale-up production in short order.

While some of the major manufacturers pump out machines and fulfill recently awarded government contracts, researchers at universities and laboratories have entered the ring with alternative ventilators falling under FDA emergency use authorization (EUA) guidelines. However, while useful in a time of need, the alternative machines that cover mechanical ventilation struggle to scratch the surface of capabilities attributable to the in-demand ICU ventilators.

Univers…

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FDA approves Medtronic’s latest DBS

Medtronic’s Percept PC neurostimulator with BrainSense technology [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) said today that it has received FDA approval for the Percept PC deep brain stimulation (DBS) system.

The medical device giant is touting Percept PC’s BrainSense technology, which is designed to sense and record brain signals while delivering DBS therapy to people with neurological disorders such as Parkinson’s disease.

BrainSense enables more personalized, data-driven neurostimulation treatment, according to Medtronic.

The FDA approval of the Percept PC neurostimulator means that health providers can use it to treat symptoms associated with Parkinson’s disease, essential tremor, primary dystonia, epilepsy and obsessive-compulsive disorder. The device gained the CE Mark in January.

Mayo Clinic in Rochester, Minn., will be th…

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