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News You Need to Know Today
IVL a top priority | Patient deaths lead to major recalls | First-in-human implants | FDA clears heart monitor | Doctor attacked
Saturday, December 21, 2024
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This Week’s News

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. 
READ MORE >

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.
READ MORE >

FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths

The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 

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Boston Scientific recalls more than 200,000 pacemakers after 2 deaths and 697 confirmed malfunctions.
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FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths

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Boston Scientific recalls more than 200,000 pacemakers after 2 deaths and 697 confirmed malfunctions.
The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 
READ MORE >

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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‘A significant step forward’: Advocates cheer as heart health bill passes Senate

The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.

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An automated external defibrillator (AED) system installed in a public location to save patients who go into sudden cardiac arrest (sudden cardiac death).
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‘A significant step forward’: Advocates cheer as heart health bill passes Senate

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An automated external defibrillator (AED) system installed in a public location to save patients who go into sudden cardiac arrest (sudden cardiac death).
The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.
READ MORE >

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 >

Man gets 9 years in jail for attacking cardiologist with champagne bottle

The cardiologist suffered multiple fractures, had to have a blood clot removed from his skull and now has permanent hearing loss in one ear. He was also left with “severe and crippling depression" following the attack. 

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man in prison behind bars
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Man gets 9 years in jail for attacking cardiologist with champagne bottle

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man in prison behind bars
The cardiologist suffered multiple fractures, had to have a blood clot removed from his skull and now has permanent hearing loss in one ear. He was also left with “severe and crippling depression" following the attack. 
READ MORE >

How one health system reduced lengths of stay, slashed readmissions after heart surgery

Remote patient monitoring helps clinicians track heart patients as they recover from major operations. One surgeon described the technology as a "game-changer," highlighting the confidence patients feel when they have "an extra set of eyes on them."  

READ MORE >
Remote patient monitoring (RPM) programs can lead to significant improvements in patient outcomes after cardiac surgery, including shorter lengths of stay and reduced readmission rates, according to the experience of one North Carolina health system. The team at Atrium Health’s Sanger Heart & Vascular Institute launched the Atrium Health Perfect Care Initiative in 2018 as a way to provide consistent, high-quality care for patients following major heart procedures.
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How one health system reduced lengths of stay, slashed readmissions after heart surgery

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Remote patient monitoring (RPM) programs can lead to significant improvements in patient outcomes after cardiac surgery, including shorter lengths of stay and reduced readmission rates, according to the experience of one North Carolina health system. The team at Atrium Health’s Sanger Heart & Vascular Institute launched the Atrium Health Perfect Care Initiative in 2018 as a way to provide consistent, high-quality care for patients following major heart procedures.
Remote patient monitoring helps clinicians track heart patients as they recover from major operations. One surgeon described the technology as a "game-changer," highlighting the confidence patients feel when they have "an extra set of eyes on them."  
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.

READ MORE >
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.
READ MORE >

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