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Week in Review: Pacemakers recalled | FDA ends semaglutide shortage | Researchers target Lp(a) | Comparing popular TAVR valves

News You Need to Know Today
Week in Review: Pacemakers recalled | FDA ends semaglutide shortage | Researchers target Lp(a) | Comparing popular TAVR valves
Saturday, March 1, 2025
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This Week’s News

FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 

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Product Recall
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FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

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Product Recall
These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 
READ MORE >

FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic

The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over. 

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Semaglutide (Wegovy) injector pen. Photo by Dave Fornell
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FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic

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Semaglutide (Wegovy) injector pen. Photo by Dave Fornell
The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over. 
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Surgeons first in world to perform open heart surgery on baby mid-delivery

The baby had been diagnosed with an especially challenging case of hypoplastic left heart syndrome.

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A baby in New York underwent open heart surgery for hypoplastic left heart syndrome as it was being delivered in what is believed to be the first operation of its kind.
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Surgeons first in world to perform open heart surgery on baby mid-delivery

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A baby in New York underwent open heart surgery for hypoplastic left heart syndrome as it was being delivered in what is believed to be the first operation of its kind.
The baby had been diagnosed with an especially challenging case of hypoplastic left heart syndrome.
READ MORE >

New drug therapies targeting Lp(a) could be a breakthrough in cardiovascular care

Lipoprotein (a) research is on the rise in recent years. Deepak Bhatt, MD, director of Mount Sinai Fuster Heart Hospital, explains why this trend is so important.

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Deepak L. Bhatt, MD, discusses research and drug therapies in development to treat lipoprotein (a). #Lp(a)
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New drug therapies targeting Lp(a) could be a breakthrough in cardiovascular care

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Deepak L. Bhatt, MD, discusses research and drug therapies in development to treat lipoprotein (a). #Lp(a)
Lipoprotein (a) research is on the rise in recent years. Deepak Bhatt, MD, director of Mount Sinai Fuster Heart Hospital, explains why this trend is so important.
READ MORE >

Teleflex to acquire Biotronik’s vascular intervention business for $791M, split into 2 separate entities

The acquisition helps Teleflex expand its interventional and vascular portfolios. Biotronik, meanwhile, is shifting its focus toward implantable devices and digital healthcare. 

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Business newspaper
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Teleflex to acquire Biotronik’s vascular intervention business for $791M, split into 2 separate entities

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Business newspaper
The acquisition helps Teleflex expand its interventional and vascular portfolios. Biotronik, meanwhile, is shifting its focus toward implantable devices and digital healthcare. 
READ MORE >

Detecting coronary inflammation on CT imaging could reshape preventive cardiology

New technology now being considered by the FDA for approval can capture coronary inflammation on CCTA images and provide risk assessments. What could this mean for the future of cardiac care? We spoke to one researcher to learn more.

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Charalambos Antoniades, MD, the British Heart Foundation Chair of Cardiovascular Medicine at the University of Oxford, is a co-founder of the company Caristo, which has developed technology to image coronary inflammation on coronary computed tomography angiography (CCTA) scans to visualize a key factor of residual cardiovascular risk.
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Detecting coronary inflammation on CT imaging could reshape preventive cardiology

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Charalambos Antoniades, MD, the British Heart Foundation Chair of Cardiovascular Medicine at the University of Oxford, is a co-founder of the company Caristo, which has developed technology to image coronary inflammation on coronary computed tomography angiography (CCTA) scans to visualize a key factor of residual cardiovascular risk.
New technology now being considered by the FDA for approval can capture coronary inflammation on CCTA images and provide risk assessments. What could this mean for the future of cardiac care? We spoke to one researcher to learn more.
READ MORE >

Continuation of 99mTc-PYP shortage prompts need for alternative cardiac amyloidosis imaging

After three years of intermittent shortages of nuclear imaging tracer technetium-99m pyrophosphate, there are no signs of the shortage abating.

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cardiac amyloidosis on bone scan. Image courtesy of the Department of Nuclear Medicine, Medical University of Vienna, Austria.
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Continuation of 99mTc-PYP shortage prompts need for alternative cardiac amyloidosis imaging

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cardiac amyloidosis on bone scan. Image courtesy of the Department of Nuclear Medicine, Medical University of Vienna, Austria.
After three years of intermittent shortages of nuclear imaging tracer technetium-99m pyrophosphate, there are no signs of the shortage abating.
READ MORE >

Medtronic enrolls first patient in new coronary DCB trial—data could lead to FDA approval

The paclitaxel-coated device, already approved in Europe and other parts of the world, will be tested on more than 1,200 patients for a new international trial. If the study is a success, Medtronic hopes to gain regulatory approval in the United States and Japan. 

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Prevail DCB Medtronic. Medtronic’s Prevail drug-coated balloon (DCB) has received CE mark approval for several new indications related to the treatment of coronary artery disease (CAD). The paclitaxel-coated device, designed to inflate within the patient’s artery during percutaneous coronary intervention (PCI) procedures, is now approved across the EU to treat CAD patients with multivessel disease, acute coronary syndrome and diabetes.
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Medtronic enrolls first patient in new coronary DCB trial—data could lead to FDA approval

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Prevail DCB Medtronic. Medtronic’s Prevail drug-coated balloon (DCB) has received CE mark approval for several new indications related to the treatment of coronary artery disease (CAD). The paclitaxel-coated device, designed to inflate within the patient’s artery during percutaneous coronary intervention (PCI) procedures, is now approved across the EU to treat CAD patients with multivessel disease, acute coronary syndrome and diabetes.
The paclitaxel-coated device, already approved in Europe and other parts of the world, will be tested on more than 1,200 patients for a new international trial. If the study is a success, Medtronic hopes to gain regulatory approval in the United States and Japan. 
READ MORE >

Popular TAVR valves linked to comparable long-term outcomes

Second-generation TAVR valves from Medtronic, Edwards Lifesciences and Boston Scientific are all associated with similar seven-year outcomes, according to a new retrospective study out of Italy. 

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
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Popular TAVR valves linked to comparable long-term outcomes

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
Second-generation TAVR valves from Medtronic, Edwards Lifesciences and Boston Scientific are all associated with similar seven-year outcomes, according to a new retrospective study out of Italy. 
READ MORE >

FDA sued over ‘reckless and arbitrary’ semaglutide decision

The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.

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FDA sued over ‘reckless and arbitrary’ semaglutide decision

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The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.
READ MORE >

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