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The 10 largest orthopedic device companies in the world

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]

Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year.

Stryker and Zimmer Biomet both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic.

GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 billion this year. The question is whether companies can continue the momentum. Stryker and ZB are betting on innovation, building arrays of products and services around their surgical robotics systems and surgical planning and digital health tools.

During Zimmer Biomet’s second-quarter earnings call, CEO Bryan Hanson noted that ZB has 40 planned product launches between this year and the end of 2025, the …

The 10 largest orthopedic device companies in the world

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker] Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year.

Stryker (NYSE: SYK) + and Zimmer Biomet (NYSE: ZBH) + both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic.

GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 billion this year. The question is whether companies can continue the momentum. Stryker and ZB are betting on innovation, building arrays of products and services around their surgical robotics systems and surgical planning and digital health tools.

During Zimmer Biomet’s second-quarter earnings call, CEO Bryan Hanson noted that ZB has 40 planned product …

Medtronic’s third recall of Mahurkar hemodialysis catheters is Class I

The FDA has labeled the Medtronic recall of some Mahurkar hemodialysis catheters as Class I, the most serious kind.

Medtronic is recalling its Mahurkar 12 Fr high-pressure triple lumen acute dialysis catheters in 20 cm length with curved extensions due to occlusions in the tip of the catheter. The company said the source of the occlusion is an excessive MDX, a silicone-based lubricant that coats the catheter tip.

According to the FDA warning letter, an occluded, partially or fully, uncured or excessive MDX may dislodge from the catheter leading to full catheter obstruction to result in a delay to treatment and partial obstruction, resulting in reduced flow or particulate dislodgment that could result in a delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus.

Mahurkar high-pressure triple-lumen acute dialysis catheters are indicated for use in hemodialysis and use three tubes. It provides central venous access for hemodialysis and aphere…

Pay drops for Medtronic CEO and the median employee; bonus plan changes

Medtronic disclosed total compensation for its top executives as well as its median worker while revealing changes to the way Medtronic Incentive Plan bonuses will be calculated.

Medtronic (NYSE:MDT) paid Chair and CEO Geoff Martha $15.4 million in fiscal 2023, the world’s largest medical device company said in its annual disclosure of pay for top executives.

That’s a 14% decrease from the year before, primarily due to Martha receiving nothing this year under the Medtronic Incentive Plan (MIP).

Pay also dropped 14% to $67,073 for Medtronic’s median worker, which the company is required to identify for comparison to CEO pay. That CEO pay ratio increased from 215:1 to 230:1 in fiscal 2023 (ended April 28, 2023).

Dublin, Ireland-based Medtronic used the same individual employee as its median worker as it did last year, saying there was “no change in our employee population or employee compensation arrangements since that median was i…

Boston Scientific’s Farapulse PFA system is poised for FDA approval, analysts say

The Farapulse system’s Farawave single-shot ablation catheter expands inside the patient to deliver energy for treating AFib. [Image courtesy of Boston Scientific]

Boston Scientific’s Farapulse pulsed-field ablation (PFA) system likely hit its primary endpoints, according to Needham analysts who say that means the technology is poised for FDA approval.

Boston Scientific has already said it expects FDA approval of Farapulse next year, but has not yet shared results from its ADVENT pivotal trial.

That data is set for release on Aug. 27 at the 2023 European Society of Cardiology (ESC) Congress. The device developer started that trial in March 2021 and stopped enrolling patients in June 2022.

Based on the trial’s adaptive design with a varying number of possible patients — 350, 450, 550, 650 or 750 — and the timing of enrollment, the Needham analysts say they suspect Boston Scientifi…

Find solutions to your most demanding medtech problem at DeviceTalks West

Add some essentials to your toolbox with engineering expertise from our upcoming show in California.

Intuitive President Dave Rosa will give a keynote interview at DeviceTalks West 2023. [Photo courtesy of Intuitive]

In the medical device industry, stubborn problems can cost millions in development expenses and delay the introduction of new life-saving tools and technologies.

That’s why we build our DeviceTalks meetings as a forum where successful medical device engineers, manufacturers and market-builders can share their best practices, providing solutions that help clear hurdles, speed product development and potentially save lives.

DeviceTalks attendees leave our meeting with notebooks full of critical advice and pockets full of business cards. We’ll help fill both at DeviceTalks West, which takes place Oct. 18-19 at the Santa Clara Convention Center in California. You can view the full agenda on our…

Ahead of Medtronic RDN’s FDA review panel, analysts place their bets

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

Analysts expect good news for Medtronic and its renal denervation (RDN) therapy for hypertension when the FDA review panel meets later this month.

RDN therapy could be a life-saver for millions of patients with high blood pressure — and a billion-dollar business for Medtronic if it wins FDA approval after two failed trials in the past decade.

The world’s largest medical device company is looking for a win after the latest RDN pivotal trial fell short of expectations, a disappointing result in a year with many other challenges. Medtronic’s revenue slipped 1% in fiscal 2023 (which ended on April 28, 2023), and net income dropped by 25% year-over-year as the company cut costs with early retirements, la…

The flaw that likely caused Medtronic’s massive ICD and CRT-D recall — and why they’re too risky to replace

Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators that may fail to deliver life-saving shocks for cardiac patients. [Photo courtesy of Medtronic]

Medtronic identified a likely design flaw that can cause defibrillator implants to halt life-saving shocks for cardiac patients.

An insulation defect appears to be to blame for Medtronic’s massive Class I recall of implantable cardioverter defibrillators (ICDs), including cardiac resynchronization therapy defibrillators (CRT-Ds).

The FDA said it has not yet determined a cause and that Medtronic is investigating. But Medtronic — the world’s largest medical device manufacturer — identified the likely problem in an urgent medical device correction notice sent to healthcare providers.

Medtronic identified 348,616 devices in the U.S. for the recall, distributed from Oct. 13, 201…

Inspire Medical Systems picks former Medtronic exec as new chief strategy officer

New Inspire Medical Systems Chief Strategy Officer Carlton Weatherby. [Image from Carlton Weatherby on LinkedIn]Inspire Medical Systems (NYSE: INSP) today announced the appointment of Carlton Weatherby as its chief strategy officer (CSO).

Weatherby’s appointment goes into effect today, July 24, 2023. He joins Inspire from Medtronic, most recently serving as VP and GM of the medtech giant’s Spine & Biologics business. Weatherby took on that role in 2021, previously serving as VP of strategic sales. He had various roles in corporate development in his time at Medtronic, which he originally joined in 2011.

Inspire said in a news release that Weatherby brings more than 15 years of experience in commercial and corporate strategy and business development in medical devices.

“We are very excited to welcome Carlton to the Inspire team,” said Tim Herbert, president and CEO. “Carlton’s vast experience in leadership roles across medtech, as well as his…

Medtronic moves its 2023 annual meeting up for first time since HQ move

Medtronic is holding its 2023 annual meeting of shareholders on Thursday, Oct. 19, 2023.

The world’s largest medical device company moved the date up from December for the first time since Medtronic relocated its Fridley, Minnesota headquarters to Ireland in 2015.

The company’s last annual meeting in Minnesota was in August 2014 at its Mounds View campus. Ever since then, Medtronic has held its annual meeting sometime during the first two weeks of December in Dublin, Ireland.

Related: 5 growth areas where Medtronic’s CEO wants to invest more

The earlier annual meeting date means any shareholders that want to nominate directors or submit any other proposal will need to do so in writing between July 21 and Aug. 30, Medtronic told investors in a filing with the U.S. Securities and Exchange Commission.

Those proposals will not be included in the proxy materials prepared for the annual meeting; the deadline for inclusion in proxy mat…

Medtronic recalls certain implantable cardiac defibrillators due to potential low energy output

Medtronic Cobalt and Crome ICDs [Image from Medtronic]The FDA designated a recall of some Medtronic (NYSE: MDT) + defibrillators as Class I, the most serious kind.

Medtronic’s recall affects implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Affected products include the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds, plus the Claria MRI, Amplia MRI, Compia MRI, Viva and Brava CRT-Ds. The recall also affects the Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI and Mirro MRI ICDs.

These devices monitor and regulate heart rate and rhythm. They automatically detect and treat life-threatening arrhythmias with electric shock (cardioversion or defibrillation) to restore a normal heartbeat. Some devices also provide cardiac resynchronization therapy to treat heart failure.

Why Medtronic recalled the devices

Medtronic recalled the ICDs and CRT-Ds, manufactured aft…

After recall and relaunch, Medtronic wants to go global with its Harmony valve

Each Medtronic Harmony valve is sewn by hand to attach laser-cut pig tissue to the nitinol that makes this minimally invasive heart implant possible.

Medtronic’s Harmony transcatheter pulmonary valve (TPV) is made of nitinol wire, polyester and laser-cut pig tissue, all sewn together by hand. [Photo courtesy of Medtronic]

Medtronic’s Harmony transcatheter pulmonary valve (TPV) design is paying off after engineers solved a delivery catheter recall and relaunched the system this year.

The Harmony TPV uses pig tissue, shape-memory alloy nitinol and manufacturing techniques old and new to solve a special challenge for children and adults.

The catheter-placed Harmony valve offers a minimally invasive way to improve the flow of blood to the lungs and delay open-heart surgery for congenital heart disease. Congenital heart defects are present in about 40,000 babies born each year, making it the most …