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News You Need to Know Today
Week in Review: J&J puts research on hold | The best diets for heart health | Boston Scientific enters IVL arms race
Saturday, January 11, 2025
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This Week’s News

Johnson & Johnson pauses use of FDA-approved PFA system to investigate patient complications

Johnson & Johnson MedTech's Varipulse PFA system has been linked to multiple reports of "neurovascular events" in patients. The company hopes to share more information in the days ahead. 

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Johnson & Johnson pauses use of FDA-approved PFA system to investigate patient complications

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Johnson & Johnson MedTech's Varipulse PFA system has been linked to multiple reports of "neurovascular events" in patients. The company hopes to share more information in the days ahead. 
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The best diets for heart health: DASH diet surpasses Mediterranean, MIND, vegan and flexitarian options

Experts say the DASH diet, designed to lower blood pressure and improve heart health, is fairly flexible and associated with several key benefits. 

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Following a plant-based diet can significantly lower a person’s risk of developing cardiovascular disease (CVD) or dying from cardiovascular causes, according to new research published in BMJ Nutrition, Prevention and Health.[1] The study’s authors emphasized that a person can still occasionally eat meat, fish or dairy products and still see substantial benefits—the key is to keep such things to a minimum and embrace fruits, vegetables, nuts, legumes, teas and coffees.
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The best diets for heart health: DASH diet surpasses Mediterranean, MIND, vegan and flexitarian options

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Following a plant-based diet can significantly lower a person’s risk of developing cardiovascular disease (CVD) or dying from cardiovascular causes, according to new research published in BMJ Nutrition, Prevention and Health.[1] The study’s authors emphasized that a person can still occasionally eat meat, fish or dairy products and still see substantial benefits—the key is to keep such things to a minimum and embrace fruits, vegetables, nuts, legumes, teas and coffees.
Experts say the DASH diet, designed to lower blood pressure and improve heart health, is fairly flexible and associated with several key benefits. 
READ MORE >

The primary reason Boston Scientific’s TAVR valve fell short in clinical trial

Michael Reardon, MD, co-principal investigator of the ACURATE IDE trial, discussed updated data on what may have impacted that study's findings.

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Michael Reardon, MD, said monitoring under expansion would have made Acurate Neo2 non-inferior to current TAVR valves in the ACURATE IDE trial.
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The primary reason Boston Scientific’s TAVR valve fell short in clinical trial

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Michael Reardon, MD, said monitoring under expansion would have made Acurate Neo2 non-inferior to current TAVR valves in the ACURATE IDE trial.
Michael Reardon, MD, co-principal investigator of the ACURATE IDE trial, discussed updated data on what may have impacted that study's findings.
READ MORE >

Boston Scientific enters IVL arms race with acquisition worth up to $664M

Boston Scientific has agreed to acquire Bolt Medical, a California-based medical device company focused on developing new intravascular lithotripsy technologies. The news comes less than one year after Johnson & Johnson acquired IVL pioneers Shockwave Medical for $13 billion.

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Money dollar investments
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Boston Scientific enters IVL arms race with acquisition worth up to $664M

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Money dollar investments
Boston Scientific has agreed to acquire Bolt Medical, a California-based medical device company focused on developing new intravascular lithotripsy technologies. The news comes less than one year after Johnson & Johnson acquired IVL pioneers Shockwave Medical for $13 billion.
READ MORE >

Reimbursement update: What hospitals need to know about new Medicare payments for cardiac CT

CMS finalized a significant policy change when it increased the Medicare payments hospitals receive for performing CCTA exams. What, exactly, does the update mean for cardiologists, billing specialists and other hospital employees?

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A CTA scan being performed at Beaumont Hospital in Michigan by cardiac CT expert Kavitha M Chinnaiyan, MD. CCTA has largely been used at academic medical centers for the past decade, but it is now expanding in 2022 to community hospitals and clinics thanks to a Class 1A recommendation in the 2021 chest pain guidelines. #CCTA #CTA #Beaumont
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Reimbursement update: What hospitals need to know about new Medicare payments for cardiac CT

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A CTA scan being performed at Beaumont Hospital in Michigan by cardiac CT expert Kavitha M Chinnaiyan, MD. CCTA has largely been used at academic medical centers for the past decade, but it is now expanding in 2022 to community hospitals and clinics thanks to a Class 1A recommendation in the 2021 chest pain guidelines. #CCTA #CTA #Beaumont
CMS finalized a significant policy change when it increased the Medicare payments hospitals receive for performing CCTA exams. What, exactly, does the update mean for cardiologists, billing specialists and other hospital employees?
READ MORE >

FDA sees value in no-implant heart failure device

The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research. 

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Alleviant Medical, a Texas-based medical device company, has received the FDA’s breakthrough device designation and an investigational device exemption (IDE) for its new atrial shunt that treats heart failure without leaving a permanent implant in the body.
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FDA sees value in no-implant heart failure device

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Alleviant Medical, a Texas-based medical device company, has received the FDA’s breakthrough device designation and an investigational device exemption (IDE) for its new atrial shunt that treats heart failure without leaving a permanent implant in the body.
The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research. 
READ MORE >

History made: Young child treated with new heart device for very first time

A care team in Illinois has performed the first heart procedure of its kind on a two-year-old patient diagnosed with Brugada syndrome. 

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From left to right: Sunita Ferns, MD; Mark Plunkett, MD; Harma Turbendian, MD. Images courtesy of OSF Healthcare.
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History made: Young child treated with new heart device for very first time

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From left to right: Sunita Ferns, MD; Mark Plunkett, MD; Harma Turbendian, MD. Images courtesy of OSF Healthcare.
A care team in Illinois has performed the first heart procedure of its kind on a two-year-old patient diagnosed with Brugada syndrome. 
READ MORE >

Medtronic’s Harmony TPVR system gains CE mark approval

The FDA-approved Harmony TPVR system is now available to patients across the EU. Nina Goodheart, president of Medtronic’s structural heart and aortic business, described the news as a "significant milestone."

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Transcatheter pulmonary valve replacement (TPVR) with Medtronic’s self-expanding Harmony valve is both safe and effective after more than a year, according to new real-world data published in the Journal of the American College of Cardiology.[1]
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Medtronic’s Harmony TPVR system gains CE mark approval

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Transcatheter pulmonary valve replacement (TPVR) with Medtronic’s self-expanding Harmony valve is both safe and effective after more than a year, according to new real-world data published in the Journal of the American College of Cardiology.[1]
The FDA-approved Harmony TPVR system is now available to patients across the EU. Nina Goodheart, president of Medtronic’s structural heart and aortic business, described the news as a "significant milestone."
READ MORE >

Stryker acquires Inari Medical for $4.9B

Stryker, a global medtech company based out of Michigan, has kicked off 2025 with a bit of excitement. The company says Inari’s peripheral vascular portfolio is highly complementary to its own neurovascular portfolio.

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Stryker acquires Inari Medical for $4.9B

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handshake
Stryker, a global medtech company based out of Michigan, has kicked off 2025 with a bit of excitement. The company says Inari’s peripheral vascular portfolio is highly complementary to its own neurovascular portfolio.
READ MORE >

Cardiologist remembered for his ‘great empathy, love and generosity’

James N. Kirkpatrick, MD, a cardiologist with the University of Washington, died unexpectedly on Jan. 1. Colleagues have shared loving tributes to Kirkpatrick, highlighting his passion for ethics and strong leadership skills.

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James N. Kirkpatrick, MD, a veteran cardiologist and cardiac imaging specialist with the University of Washington, died unexpectedly on Jan. 1. He was 54 years old.
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Cardiologist remembered for his ‘great empathy, love and generosity’

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James N. Kirkpatrick, MD, a veteran cardiologist and cardiac imaging specialist with the University of Washington, died unexpectedly on Jan. 1. He was 54 years old.
James N. Kirkpatrick, MD, a cardiologist with the University of Washington, died unexpectedly on Jan. 1. Colleagues have shared loving tributes to Kirkpatrick, highlighting his passion for ethics and strong leadership skills.
READ MORE >

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