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…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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.

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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.

Next>>
Read more
  • 0

States reportedly fend for themselves with inflated ventilator prices

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

States had to scramble to obtain ventilators after the White House left them to fend for themselves, according to a Kaiser Health News report.

Demand for intensive care unit ventilators skyrocketed as healthcare facilities dealt with the surges of COVID-19 patients over the course of the pandemic, which still goes on today after gaining steam in March. Kaiser’s report noted that White House officials, such as senior adviser (and President Donald Trump’s son-in-law) Jared Kushner, claimed the federal stockpile was not meant for the states, leaving them to track down ventilators elsewhere.

As the Trump administration sought to replenish its own supply of ventilators, officials from a number of states have said that they ordered millions of dollars’ worth of machines from private companies, sometimes bidding against the fed…

Read more
  • 0

Blackstone invests $337m in Medtronic diabetes tech

Medtronic (NYSE:MDT) announced that it will increase research and development for its diabetes group through an agreement to receive $337 million from Blackstone.

The significant increase in R&D funding for the diabetes group is aimed at advancing new, innovative products designed to reduce the burden of diabetes management. The companies announced the agreement at the virtual 80th Scientific Sessions of the American Diabetes Association (ADA).

“This investment is important for people living with diabetes, as we expect it will expand our offering of future insulin delivery and sensor innovations that have the potential to improve patients’ management of their diabetes,” Medtronic executive VP & diabetes group president Sean Salmon said in a news release. “Over the past 12 months, Medtronic has significantly increased its investment in diabetes R&D, including investments in a series of near-term programs such as the MiniMed 780G insulin…

Read more
  • 0

Medtronic lands CE Mark for Micra AV transcatheter pacing system

Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its Micra AV transcatheter pacing system (TPS).

The Fridley, Minn.-based medtech giant touts its Micra AV as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The system is indicated for treating patients with AV block, adding to its CE Mark-approved leadless pacemaker portfolio.

Dr. José Ramón González Juanatey of the University Hospital in Santiago de Compostela, Spain, performed the first implants of Micra AV, according to a news release.

“This new device not only stimulates but is also able to recognize the electrical activity of the whole heart,” Juanetey said in the release. “Our ultimate goal is to bring the latest cardiovascular innovation to patients in our area. Now we can extend this wireless technology to other patients who require dual-chamber stimulation and in whom traditional stimulation cannot be p…

Read more
  • 0

Medtronic touts results of latest MiniMed studies at ADA

The latest generation of the Medtronic (NYSE:MDT) MiniMed insulin pump met both safety and glycemic endpoints in a study presented today at the American Diabetes Association’s virtual annual conference.

The MiniMed 780G closed-loop system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It is designed to automate the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease, according to Fridley, Minn.-based Medtronic. It also enables patients to program insulin action time from two to eight hours, and has an adjustable target setting as low as 100 mg/dL. The MiniMed 780G won the CE Mark this week, but has not been approved for use in the U.S.

The 90-day at home U.S. pivotal trial included patients aged 14 to 75 years old and yielded no severe adverse events, according to the company. The trial results include:

No severe hypoglycemia and diab…
Read more
  • 0