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News You Need to Know Today
December's Top Stories: Deaths lead to major recalls | IVL a top priority | Mass layoffs | Heart surgeon discusses robotic AVR
Monday, December 30, 2024
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The Month in Review

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 >

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 >

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 >

Medical device company cuts 70% of staff in push to meet Medtronic obligations

California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
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Medical device company cuts 70% of staff in push to meet Medtronic obligations

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 
READ MORE >

Heart surgeons perform world’s first combined robotic AVR and CABG

The entire robotic procedure was performed through one small incision. Surgeons originally recommended the 73-year-old patient undergo open-heart surgery, but she requested a less invasive alternative. 

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Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first combined robotic aortic valve replacement (AVR) and coronary artery bypass grafting (CABG) procedure—all through one small incision. Patients requiring these procedures typically undergo open-heart surgery. Image courtesy of WVU Medicine.
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Heart surgeons perform world’s first combined robotic AVR and CABG

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Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first combined robotic aortic valve replacement (AVR) and coronary artery bypass grafting (CABG) procedure—all through one small incision. Patients requiring these procedures typically undergo open-heart surgery. Image courtesy of WVU Medicine.
The entire robotic procedure was performed through one small incision. Surgeons originally recommended the 73-year-old patient undergo open-heart surgery, but she requested a less invasive alternative. 
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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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Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 

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Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

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Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 
READ MORE >

‘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 >

Q&A: Pioneer heart surgeon on the development and long-term potential of robotic aortic valve replacement

It's early for RAVR, but the minimally invasive technique has already started gaining momentum as an alternative to both SAVR and TAVR. We spoke to Vinay Badhwar, MD, one of the world’s leading voices in robotic heart surgery, to learn more.

READ MORE >
Robotic aortic valve replacement (RAVR) is a new minimally invasive treatment option for symptomatic severe aortic stenosis (AS) that uses advanced robotic surgical systems. It has already started gaining momentum as an alternative to both surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).
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Q&A: Pioneer heart surgeon on the development and long-term potential of robotic aortic valve replacement

Share on Twitter Share on Facebook Share on Linkedin
Robotic aortic valve replacement (RAVR) is a new minimally invasive treatment option for symptomatic severe aortic stenosis (AS) that uses advanced robotic surgical systems. It has already started gaining momentum as an alternative to both surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).
It's early for RAVR, but the minimally invasive technique has already started gaining momentum as an alternative to both SAVR and TAVR. We spoke to Vinay Badhwar, MD, one of the world’s leading voices in robotic heart surgery, to learn more.
READ MORE >

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.
READ MORE >

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