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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Medtronic wins CE mark for TAVI system in low-risk patients

Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system.

Evolut TAVI, now commercially launched in Europe, is now indicated for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The system’s indications in Europe now cover all risk categories for severe aortic stenosis patients.

Clinical data from a global, randomized trial that evaluated three valve generations against surgical valve replacement (SAVR) in more than 1,400 patients revealed that TAVI is an effective treatment for low-risk patients, improving 30-day quality-of-life scores compared to SAVR.

Additionally, Evolut displayed superior hemodynamic performance with lower mean aortic valve gradients and larger effective orifice areas compared to surgery at one year.

Medtronic engineered Evolut with a self-expanding nitinol frame that confo…

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MedTech 100 roundup: Another rebound as markets continue to fluctuate

Medtech stocks rebounded from a significant dip earlier in June last week, continuing to highlight the topsy-turvy nature of the markets during the COVID-19 pandemic.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 85.00 points at the end of last week (June 19). That total represents a 3.5% increase from the 82.12-point total at the same time a week prior (June 12), demonstrating another uptick after a -6% drop-off just one week before.

Meanwhile, the S&P 500 Index experienced a 1.9% increase from June 12 to June 19, and the Dow Jones Index fared slightly worse with a 1% increase over the same period of time. Both indexes mirrored medtech’s rebound, having posted -4.8% and -5.6% decreases, respectively, the week before.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 36.8% growth in total. Stocks i…

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DeviceTalks Weekly: Stryker CEO Kevin Lobo says medtech can increase workforce diversity

DeviceTalks Weekly

This week’s DeviceTalks Weekly podcast episode talks with industry leaders about improving worker diversity and developing new ways to treat COVID-19 patients.

Kevin Lobo, chairman and CEO of Stryker, explains how his company — and the industry group AdvaMed that he currently leads — has been working  to increase diversity of its workforce, particularly in senior and sales positions.

Lobo is serving a two-year term as chairman of AdvaMed. In this interview, he speaks specifically to how Stryker is tracking progress, where it has come up short and how it’s working to help workers identify their own biases.

Lobo also says Stryker is poised to regain momentum after the pandemic.

Next, Kevin Sayer, executive chairman, CEO and president of Dexcom, says the company’s continuous glucose monitors are finding a home in hospitals as they help monitor the health of COVID-19 patie…

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Medtronic, Foxconn aim to make 10,000 ventilators

The Puritan Bennett 560 (PB 560) ventilator [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) and Foxconn said today they will boost ventilator production to 10,000 over the next year at Foxconn’s Wisconsin plant.

The companies announced in April that Foxconn would begin production of Medtronic’s Puritan Bennett 560 ventilators at the plant in Mount Pleasant, Wis., with a goal of 400 ventilators per week by the end of April and 700 per week by the end of May. These were in addition to the 1,000 per week that Medtronic projected manufacturing on its own by the end of June. Medtronic will market and sell the ventilators made in Foxconn’s plant under its own name.

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

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Medtronic touts results of venous self-expanding stent system study

Medtronic’s Abre stent (image from Medtronic)

Medtronic (NYSE:MDT) announced that the clinical trial for its Abre venous self-expanding stent system met its primary safety and effectiveness endpoints.

The Abre stent system is designed for treating patients with iliofemoral venous outflow obstruction. The prospective, interventional, single-arm, multi-center, global trial with 200 subjects across 24 sites evaluated primary patency at 12 months for effectiveness and major adverse events within 30 days for safety.

Patients included in the study ranged across the spectrum of deep venous disease, with subjects suffering from post-thrombotic syndrome (PTS), non-thrombotic iliac vein lesions (NIVL), and those with an acute deep vein thrombosis (aDVT).

According to data presented virtually at the 2020 Charing Cross Symposium, the study met its primary safety endpoint with a 2% (4 out of 200) rate…

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Medtronic touts results of venous self-expanding stent system study

Medtronic’s Abre stent (image from Medtronic)

Medtronic (NYSE:MDT) announced that the clinical trial for its Abre venous self-expanding stent system met its primary safety and effectiveness endpoints.

The Abre stent system is designed for treating patients with iliofemoral venous outflow obstruction. The prospective, interventional, single-arm, multi-center, global trial with 200 subjects across 24 sites evaluated primary patency at 12 months for effectiveness and major adverse events within 30 days for safety.

Patients included in the study ranged across the spectrum of deep venous disease, with subjects suffering from post-thrombotic syndrome (PTS), non-thrombotic iliac vein lesions (NIVL), and those with an acute deep vein thrombosis (aDVT).

According to data presented virtually at the 2020 Charing Cross Symposium, the study met its primary safety endpoint with a 2% (4 out of 200) rate…

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Medtech manufacturers must add warning label to drug-eluting PAD devices

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks.

A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after 5 years and a 93% relative risk after 5 years compared to therapy with an uncoated balloon.

Labeling changes will apply to instructions for use of these devices throughout Europe and will  include a warning and a summary of the Katsanos publication plus supplemented with the clinical data specific to each device. No device…

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Abbott, Medtronic go head-to-head at ADA conference

Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology.

The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller companies as well as studies showing how diabetes tech is helping diverse patient populations. More than 800 sessions have been planned.

Here are some of the highlights of this year’s conference, which began June 12.

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