September 2021 Issue: Our latest Medical Device Handbook is out!

 

Making medical devices: Everything you need to know

The innovation-fueled evolution of drug eluting stents

Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’

Getting the inside scoop behind top medtech innovations

Autumn is upon us, and it is once again time to sip a pumpkin spice latte  — or a pumpkin beer — and crack open our latest Medical Device Handbook.

Once again, we’ve reached out to experts across the industry to curate dozens of “what is” and “how to” types of articles that cover a breadth of categories: components, drug delivery, manufacturing and machining, materials, product design and development, regulatory, software, sterilization services and tubing.

As the years go by, I’m proud that we’re including more insights from the major medical device companies in each succeeding issue. This time around, we spoke to experts involved in some of the major industry innovations of the past decade:

Now VP of R&D …
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Design considerations you need to know when making ablation catheters to treat AFib

CardioFocus’s HeartLight X3 ablation catheter and balloon [Image courtesy CardioFocus]Catheters are increasingly deploying heart devices in minimally invasive procedures. CardioFocus VP of engineering Jerry Melsky describes the components and design considerations that go into making successful ablation catheters to treat AFib. 

Atrial fibrillation (AFib) is the most common irregular heart rhythm disorder. If the atria of the heart beats rapidly and irregularly, blood does not flow through the heart as quickly, according to the Cleveland Clinic. The irregular heartbeat makes the blood more likely to clot, and if the clot leaves the heart, it can travel to the brain and cause a stroke or to the coronary arteries and cause a heart attack.

There are several ways to treat AFib, including various medications, procedures such as electrical cardioversion and pulmonary vein ablation, and devices like pacemakers and left atrial appendage occluders.

Ablation procedur…

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Design considerations you need to know when making ablation catheters to treat AFib

CardioFocus’s HeartLight X3 ablation catheter and balloon [Image courtesy CardioFocus]

Catheters are increasingly deploying heart devices in minimally invasive procedures. CardioFocus VP of engineering Jerry Melsky describes the components and design considerations that go into making successful ablation catheters to treat AFib. 

Atrial fibrillation (AFib) is the most common irregular heart rhythm disorder. If the atria of the heart beats rapidly and irregularly, blood does not flow through the heart as quickly, according to the Cleveland Clinic. The irregular heartbeat makes the blood more likely to clot, and if the clot leaves the heart, it can travel to the brain and cause a stroke or to the coronary arteries and cause a heart attack.

There are several ways to treat AFib, including various medications, procedures such as electrical cardioversion and pulmonary vein ablation, and devices like pace…

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CardioFocus names new CFO

CardioFocus today said it appointed Stephan Ogilvie as chief financial officer.

Prior to joining the Marlborough, Mass.-based company, Ogilvie served as managing director of healthcare investment banking at B Riley Securities. He has also served as VP of corporate development at Nuvasive and has held numerous leadership roles at ThinkEquity Partners, Lazard Capital Markets and Medtronic.

Get the full story on our sister site, Medical Tubing + Extrusion.

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CardioFocus wins Japan regulatory approval for HeartLight X3 system

CardioFocus today said its HeartLight X3 catheter ablation technology received approval from the Japanese Ministry of Health, Labor and Welfare.

Marlborough, Mass.-based CardioFocus designed the catheter ablation technology for controlled and consistent pulmonary vein isolation to treat atrial fibrillation (AFib).

Get the full story on our sister site, Medical Tubing + Extrusion.

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CardioFocus, China Grand Pharmaceutical partner to commercialize catheter ablation system in China

CardioFocus today announced that it signed a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China.

Marlborough, Mass.-based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment for atrial fibrillation (AFib).

Get the full story on our sister site, Medical Tubing + Extrusion.

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15 heart devices that could boost their manufacturers’ sales

(Image from Cardiovalve)

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices.

Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures.

Now hospitals are looking at ways to safely return to business-as-usual — they and the medical device industry as a whole hope to improve their balance sheets. For example, Medtronic (NYSE:MDT) CEO Geoff Martha and CFO Karen Parkhill expressed optimism in an analyst call today that their company’s businesses already are showing signs of a rebound in the month of May.

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

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