Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit

Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit.

Fridley, Minn.-based Medtronic’s catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of malignant lesions in the lung, according to a news release. It can also be used together with the standard of care therapy when indicated.

Get the full story at our sister site, Medical Tubing & Extrusion.

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Medtronic, Surgical Theater partner on augmented reality platform for cranial procedures

Medtronic (NYSE:MDT) announced today that it partnered with Surgical Theater to offer an augmented reality platform for cranial procedures.

Fridley, Minn.-based Medtronic will interface its StealthStation S8 surgical navigation system with Surgical Theater’s SyncAR technology in an effort to enable neurosurgeons to use AR in real-time to enhance their visualization during complex cranial procedures, according to a news release.

SyncAR is designed to allow surgeons to visualize brian structures, test virtual surgical tools and plan surgeries before entering the operating room through fighter-jet simulation technology. StealthStation S8 is designed to track surgical instruments and guide the user during procedures through hardware and clinical software with tracking and image dataset merging algorithms.

Integration of SyncAR into the StealthStation S8 cranial solution is set to give surgeons the opportunity to expand the benefits of AR and see a 360°…

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DeviceTalks Weekly Podcast – iRhythm CEO Mike Coyle, New Podcast!

In this podcast, iRhythm CEO Mike Coyle discusses his decision to join the digital health leader in January.

Coyle’s had to hit the ground running as iRhythm manages some challenging decisions from regional Medicare payors but he also sees great opportunity for the company’s ZIO platform across the healthcare spectrum.

In this conversation, Coyle discusses

How he came to join the Medtech industry. The potential for its ZIO cardiac monitoring technology How the company is dealing with a disappointing reimbursement How the company will pursue the large asymptomatic market What’s expected to come from the company’s partnership with Verily

We also introduce the newest member of our DeviceTalks Podcast family! Catch an excerpt of the first episode in this week’s podcast. Subscribe to hear future episodes.

Caffeine-fueled Chris Newmarker, executive editor of life sciences at Mass Device, takes a break from earnings week to roll out a powerful #newmark…

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The 10 largest orthopedic device companies in the world

[Image from Pixaby]Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the world’s 10 largest orthopedic device companies.

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The 10 largest orthopedic device companies in the world

[Image from Pixaby]

Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the w…

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FDA approves Medtronic’s next-gen Pipeline Flex device with anti-clotting tech

Medtronic (NYSE:MDT) announced today that it received FDA approval for its Pipeline Flex embolization device with Shield Technology.

Fridley, Minn.–based Medtronic’s Shield Technology is a proprietary platform designed to advance flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material to create clots — according to a news release.

New York City-based NYU Langone Health performed the first patient procedure in the U.S. with the newly cleared Pipeline Flex device with Shield Technology.

Pipeline Flex, which has been on the market for close to 10 years in the U.S., is a device designed to divert blood flow away from a brain aneurysm. A braided, cylindrical mesh tube is implanted across the base or neck of the aneurysm. It interrupts blood flow into the aneurysm and reconstructs the diseased section of the parent vessel. Read more

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Medtronic touts 2-year study results for In.Pact AV drug-coated balloon

Medtronic (NYSE:MDT) today touted safety and effectiveness results from a 24-month study of its In.Pact AV drug-coated balloon.

Fridley, Minn.-based Medtronic said in a news release that the data demonstrated that the In.Pact AV DCB is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal angioplasty (PTA) in end-stage renal disease (ESRD) patients with de novo or non-stented restenotic native arteriovenous fistulae (AVF) in the upper extremity.

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

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Medtronic blood pump recall is serious

Medtronic Bio Console 560 system (Image from Medtronic)

Medtronic (NYSE: MDT) is recalling a blood pump that can stop during cardiopulmonary bypass surgery due to electrical failure.

The Bio-Console 560 extracorporeal blood pumping console is used to pump and return blood to a person during bypass, a procedure that temporarily takes over the function of the heart and lungs. The cardiopulmonary bypass procedure provides both circulatory and breathing support to a person whose heart and lungs are too weak to pump enough blood to the rest of the body.

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

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9 medical devices you should keep an eye out for in 2021

The medical device industry weathered the COVID-19 pandemic well — and is now set to roll out a host of innovations in 2021.

Economists generally expect the U.S. to see a boom as we emerge from the pandemic and resulting recession. Medtech companies appear set to ride the wave this year, with plans to seek approval or launch a wide range of new products.

Think surgical robotics, smart orthopedic implants, neurostimulation, single-use scopes and much more.

Here are nine devices to especially keep an eye out for this year.

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Medtronic has another serious HVAD recall

Medtronic’s HVAD [Image courtesy of Medtronic]The FDA is reporting 12 deaths related to a recall of Medtronic (NYSE:MDT) HeartWare Ventricular Assist Device controller ports.

The recall — which Medtronic initiated on Feb. 26 and FDA designated as Class I — is related to 855 complaints and eight reports of injuries, according to the FDA. Medtronic said today that the FDA’s figures are inaccurate.

The HVAD pump helps the heart continue to pump blood to the rest of the body, providing a bridge to cardiac transplants among people at risk of death from end-stage left ventricular heart failure. HVADs can also support heart tissue recovery and provide a destination therapy when there are no plans for new transplants.

The latest recall involves battery cables, data cables, adapter cables and controller 2.0 ports for HeartWare, according to FDA. Wear and tear of the connector plugs (power sources, data cable, and alarm adapter) can damage the controller …

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Medtronic launches 7-day infusion set for diabetes in Europe

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it launched the Medtronic Extended infusion set for diabetes in select European countries.

Fridley, Minn.–based Medtronic touts the Extended infusion set as the first and only infusion set that a diabetes patient can wear for up to seven days, as most typically infusion pumps that deliver insulin to the body require a set change every few days, according to a news release.

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

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Medtronic has a serious recall of ICDs and CRT-Ds

FDA has issued a Class I designation of a Medtronic (NYSE: MDT) recall involving 239,171 ICDs and CRT-Ds with potential battery life problems.

The agency reported 444 complaints regarding the devices: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) distributed from Aug. 31, 2012, to May 9, 2018.

Among 264 Medical Device Reports, there were 18 injuries, including people experiencing bradycardia (slow heart rhythm) or heart failure symptoms. There were no reports of deaths.

The devices’ problem involves a potential short circuit that could cause an unexpected and rapid decrease in battery life. The time between the first “Recommended Replacement Time”  warning and full battery depletion could be as little as one day. However, a Medtronic spokesperson noted to MassDevice that the median time from RRT to end of service was 14 days.

Medtronic is no…

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