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News You Need to Know Today
FDA updates indications for Impella RP | Seaweed & heart surgery? | Progress for pulsed-field ablation trial
Tuesday, December 6, 2022
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Today's News and Trends

FDA changes indications for Impella RP heart pump after dramatic shift in mortality rate

The Impella RP System is still associated with significant benefits, the FDA said, but there are certain high-risk patients who should no longer be eligible for treatment.

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IVUS guidance during DES implantation boosts long-term outcomes in new study
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FDA changes indications for Impella RP heart pump after dramatic shift in mortality rate

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IVUS guidance during DES implantation boosts long-term outcomes in new study
The Impella RP System is still associated with significant benefits, the FDA said, but there are certain high-risk patients who should no longer be eligible for treatment.
READ MORE >

Seaweed molecules could lead to big improvements for heart surgery patients

“There is a crucial need to develop synthetic vascular graft materials that will increase the rate of long-term functions,” one researcher said. Could materials derived from seaweed help fill that need?

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seaweed water ocean
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Seaweed molecules could lead to big improvements for heart surgery patients

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seaweed water ocean
“There is a crucial need to develop synthetic vascular graft materials that will increase the rate of long-term functions,” one researcher said. Could materials derived from seaweed help fill that need?
READ MORE >

Medtronic reaches milestone in study of pulsed-field ablation and mapping catheter for AFib

A randomized study of more than 450 patients with persistent atrial fibrillation is now underway. All patients have been treated, and their outcomes will be tracked for 12 months. 

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Sphere-9 mapping and ablation catheter
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Medtronic reaches milestone in study of pulsed-field ablation and mapping catheter for AFib

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Sphere-9 mapping and ablation catheter
A randomized study of more than 450 patients with persistent atrial fibrillation is now underway. All patients have been treated, and their outcomes will be tracked for 12 months. 
READ MORE >

Featured Articles

Supply chain problems: FDA warns of new shortage of intra-aortic balloon pumps, catheters and spare parts

Getinge has provided a detailed breakdown of the shortage, stating that it is not yet clear when it may be over. The FDA said it will keep a close eye on the situation and provide updates when possible. 

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An inflated intra-aortic balloon pump (IABP) with the Maquet Cardiosave system.
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Supply chain problems: FDA warns of new shortage of intra-aortic balloon pumps, catheters and spare parts

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An inflated intra-aortic balloon pump (IABP) with the Maquet Cardiosave system.
Getinge has provided a detailed breakdown of the shortage, stating that it is not yet clear when it may be over. The FDA said it will keep a close eye on the situation and provide updates when possible. 
READ MORE >

FDA announces another recall for troubled heart device after multiple hospitalizations

This latest recall involves the device's driveline boot cover, which “can become stiff over time” and cause problems for clinicians. There have been 33 complaints since 2017 related to the issue.

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Recall | Product recall
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FDA announces another recall for troubled heart device after multiple hospitalizations

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Recall | Product recall
This latest recall involves the device's driveline boot cover, which “can become stiff over time” and cause problems for clinicians. There have been 33 complaints since 2017 related to the issue.
READ MORE >

In Case You Missed It

PHOTO GALLERY: AHA 2022

A photo essay from the American Heart Association (AHA) 2022 Scientific Sessions Nov. 5-7 in Chicago.

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Example of fractional flow reserve (FFR) calculated using AI and assessment of the plaque in the vessel on a CT scan of the coronaries. This new type of FFR-CT was shown as a work-in-progress by the vendor Elucid. It was shown for the first time at AHA 2022.
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PHOTO GALLERY: AHA 2022

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Example of fractional flow reserve (FFR) calculated using AI and assessment of the plaque in the vessel on a CT scan of the coronaries. This new type of FFR-CT was shown as a work-in-progress by the vendor Elucid. It was shown for the first time at AHA 2022.
A photo essay from the American Heart Association (AHA) 2022 Scientific Sessions Nov. 5-7 in Chicago.
READ MORE >

Early catheter ablation superior to medication when treating ventricular tachycardia storm

VT storm is associated with a heightened risk of death or significant complications. Early catheter ablation, it seems, is the most effective treatment option for this potentially fatal condition. 

READ MORE >
surgery.jpg
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Early catheter ablation superior to medication when treating ventricular tachycardia storm

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surgery.jpg
VT storm is associated with a heightened risk of death or significant complications. Early catheter ablation, it seems, is the most effective treatment option for this potentially fatal condition. 
READ MORE >

In Other News

Integra LifeSciences to acquire SIA in deal worth up to $140M

Integra LifeSciences Holding Corporation, a global medical technology company, has agreed to acquire Surgical Innovation Associates (SIA), which is known as the manufacturer of monofilament mesh for plastic and reconstructive surgery. The deal is valued up to $140 million.

READ MORE >
Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
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Integra LifeSciences to acquire SIA in deal worth up to $140M

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Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
Integra LifeSciences Holding Corporation, a global medical technology company, has agreed to acquire Surgical Innovation Associates (SIA), which is known as the manufacturer of monofilament mesh for plastic and reconstructive surgery. The deal is valued up to $140 million.
READ MORE >

'Crash course' on COVID cases benefits residents less experienced with thoracic CT

Following the course, experts observed nearly perfect agreement between less experienced residents and chest-devoted radiologists.

READ MORE >
Lung CT of a 42-year-old man with more than 7 days of symptoms. Scans show COVID pneumonia with diffuse ground-glass opacities in close vicinity of visceral pleural surfaces. In addition, a crazy paving pattern is observed. Image courtesy of RSNA. Medical images of COVID. #COVID #SARS-CoV-2
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'Crash course' on COVID cases benefits residents less experienced with thoracic CT

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Lung CT of a 42-year-old man with more than 7 days of symptoms. Scans show COVID pneumonia with diffuse ground-glass opacities in close vicinity of visceral pleural surfaces. In addition, a crazy paving pattern is observed. Image courtesy of RSNA. Medical images of COVID. #COVID #SARS-CoV-2
Following the course, experts observed nearly perfect agreement between less experienced residents and chest-devoted radiologists.
READ MORE >

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