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News You Need to Know Today
Cryoablation catheters recalled | Merck spends big on new drug | SAVR bests TAVR | FDA expands total artificial heart study
Thursday, December 19, 2024
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Today's News and Trends

FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths

Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.

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Product Recall
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FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths

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Product Recall
Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.
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Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met. 

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Money dollar investments
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Merck spends up to $2B to license new weight loss drug with potential heart benefits

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Money dollar investments
Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met. 
READ MORE >

SAVR outperforms TAVR in patients with bicuspid aortic valves

BAV patients are often excluded from TAVR trials, creating uncertainty about the best way to treat that population when aortic valve replacement is required. To learn more, researchers tracked CMS data from 2018 to 2022, presenting their findings in The Annals of Thoracic Surgery.

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Heart cardiologists doctors surgery
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SAVR outperforms TAVR in patients with bicuspid aortic valves

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Heart cardiologists doctors surgery
BAV patients are often excluded from TAVR trials, creating uncertainty about the best way to treat that population when aortic valve replacement is required. To learn more, researchers tracked CMS data from 2018 to 2022, presenting their findings in The Annals of Thoracic Surgery.
READ MORE >

‘Incredibly rewarding’: FDA expands total artificial heart study after early success

An additional 15 patients will now receive BiVacor's titanium total artificial heart technology as they wait for a permanent transplant.

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Surgeons in Houston have performed the world’s first successful human implant of BiVacor’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023. BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH).
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‘Incredibly rewarding’: FDA expands total artificial heart study after early success

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Surgeons in Houston have performed the world’s first successful human implant of BiVacor’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023. BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH).
An additional 15 patients will now receive BiVacor's titanium total artificial heart technology as they wait for a permanent transplant.
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Featured Articles

FDA clears credit card-sized heart monitor

The new device was designed to help patients evaluate their own heart health in real time.

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HeartBeam, a California-based healthcare technology company, has received U.S. Food and Drug Administration (FDA) clearance for its cable-free, credit card-sized heart monitor that produces 12-lead electrocardiograms (ECGs).
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FDA clears credit card-sized heart monitor

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HeartBeam, a California-based healthcare technology company, has received U.S. Food and Drug Administration (FDA) clearance for its cable-free, credit card-sized heart monitor that produces 12-lead electrocardiograms (ECGs).
The new device was designed to help patients evaluate their own heart health in real time.
READ MORE >

Intravascular lithotripsy technology now a top priority for many healthcare companies

After the significant success of Shockwave Medical's IVL therapy to break up heavily calcified vessels without trauma, there are now several companies working on their own IVL devices. 

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Philips Healthcare's combined IVL and laser atherectomy catheter that is being used in the THOR trial to treat heavily calcified peripheral artery lesions.
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Intravascular lithotripsy technology now a top priority for many healthcare companies

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Philips Healthcare's combined IVL and laser atherectomy catheter that is being used in the THOR trial to treat heavily calcified peripheral artery lesions.
After the significant success of Shockwave Medical's IVL therapy to break up heavily calcified vessels without trauma, there are now several companies working on their own IVL devices. 
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Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.

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Left: Petr Neužil, MD, PhD, head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic / Right: Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City
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Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

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Left: Petr Neužil, MD, PhD, head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic / Right: Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City
The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.
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President of medical device company resigns over conduct allegations after 7 months in role

Joseph C. Wright, a longtime Merit Medical employee, resigned after unspecified allegations regarding his conduct were brought to light. He was named the company's new president back in May.

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Joseph C. Wright resigns from Merit Medical
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President of medical device company resigns over conduct allegations after 7 months in role

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Joseph C. Wright resigns from Merit Medical
Joseph C. Wright, a longtime Merit Medical employee, resigned after unspecified allegations regarding his conduct were brought to light. He was named the company's new president back in May.
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In Case You Missed It

TAVR/PCI bests SAVR/CABG when treating severe AS and complex CAD

Percutaneous treatment was linked to improved survival and fewer adverse events than surgery when patients presented with both symptomatic severe aortic stenosis and complex coronary artery disease. 

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
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TAVR/PCI bests SAVR/CABG when treating severe AS and complex CAD

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
Percutaneous treatment was linked to improved survival and fewer adverse events than surgery when patients presented with both symptomatic severe aortic stenosis and complex coronary artery disease. 
READ MORE >

Insulet wins $452M in lawsuit against rivals over medical device trade secrets

Insulet accused multiple parties, including a rival CEO, of working together to copy its insulin pump technology and bring a "clone product" to market.

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statue justice legal verdict malpractice case lawsuit scale
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Insulet wins $452M in lawsuit against rivals over medical device trade secrets

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statue justice legal verdict malpractice case lawsuit scale
Insulet accused multiple parties, including a rival CEO, of working together to copy its insulin pump technology and bring a "clone product" to market.
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TAVR survival less likely when patients are depressed

Screening TAVR patients for signs of depression prior to treatment could help providers adapt as necessary and deliver better patient care.

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USPSTF updates its stance on aspirin use to prevent CVD, sees no benefit for patients 60 or older.
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TAVR survival less likely when patients are depressed

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USPSTF updates its stance on aspirin use to prevent CVD, sees no benefit for patients 60 or older.
Screening TAVR patients for signs of depression prior to treatment could help providers adapt as necessary and deliver better patient care.
READ MORE >

In Other News

Hologic recalling breast care device after 252 injuries, slew of patient lawsuits

More than 100 plaintiffs have now sued the Marlborough, Massachusetts-based mammography-maker, claiming they suffered injuries and emotional distress stemming from implantation of the BioZorb radiographic marker. 

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BioZorb 3D bioabsorbable marker Hologic
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Hologic recalling breast care device after 252 injuries, slew of patient lawsuits

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BioZorb 3D bioabsorbable marker Hologic
More than 100 plaintiffs have now sued the Marlborough, Massachusetts-based mammography-maker, claiming they suffered injuries and emotional distress stemming from implantation of the BioZorb radiographic marker. 
READ MORE >

Most patients want to know if AI is involved in their care

“With this signal about the public’s preference for notification, the question for health systems and policymakers is not whether to notify patients but when and how.” 

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AI in healthcare
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Most patients want to know if AI is involved in their care

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AI in healthcare
“With this signal about the public’s preference for notification, the question for health systems and policymakers is not whether to notify patients but when and how.” 
READ MORE >

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