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FDA’s approval process puts heart patients at risk | Redo TAVR in Evolut valves | US Heart & Vascular's new partnership

News You Need to Know Today
FDA’s approval process puts heart patients at risk | Redo TAVR in Evolut valves | US Heart & Vascular's new partnership
Friday, April 21, 2023
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Today's News and Trends

How the FDA’s approval process puts the safety of heart patients at risk

After high-risk medical devices go through the initial FDA approval process, it is relatively easy for manufacturers to get updates to those devices approved. New evidence suggests that this policy could be leading to more recalls, especially among cardiovascular devices.  

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Product Recall
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How the FDA’s approval process puts the safety of heart patients at risk

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Product Recall
After high-risk medical devices go through the initial FDA approval process, it is relatively easy for manufacturers to get updates to those devices approved. New evidence suggests that this policy could be leading to more recalls, especially among cardiovascular devices.  
READ MORE >

Redo TAVR appears feasible for most patients with supra-annular, self-expanding Evolut valves

Researchers evaluated data from more than 200 patients who underwent redo TAVR, noting that women and patients with a higher BMI faced a higher risk of coronary flow compromise.

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The Medtronic Evolut TAVR valve on display at ACC.22.
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Redo TAVR appears feasible for most patients with supra-annular, self-expanding Evolut valves

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The Medtronic Evolut TAVR valve on display at ACC.22.
Researchers evaluated data from more than 200 patients who underwent redo TAVR, noting that women and patients with a higher BMI faced a higher risk of coronary flow compromise.
READ MORE >

Private equity-backed US Heart and Vascular adds large Texas-based cardiology practice to its roster

HeartPlace, a Dallas-based cardiology practice with more than 20 locations, is the newest member of the USHV family. 

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Private equity-backed US Heart and Vascular adds large Texas-based cardiology practice to its roster

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HeartPlace, a Dallas-based cardiology practice with more than 20 locations, is the newest member of the USHV family. 
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Featured Articles

Medtronic laying off undisclosed number of employees to reduce costs

“These decisions are never easy, and we’re taking great care to treat all impacted employees with dignity and respect," the company told Cardiovascular Business in a statement.

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layoffs staff cuts termination workforce
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Medtronic laying off undisclosed number of employees to reduce costs

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layoffs staff cuts termination workforce
“These decisions are never easy, and we’re taking great care to treat all impacted employees with dignity and respect," the company told Cardiovascular Business in a statement.
READ MORE >

Cardiologist charged with multiple counts of sexual assault—police say there may be more victims

The doctor was charged with three counts of sexual assault related to an alleged date rape from January. A preliminary hearing has been scheduled for May. 

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The long legal saga of Richard Paulus, a Kentucky cardiologist accused of performing unnecessary cardiac procedures, appears to still be going strong in 2022 and might be reviewed by the Supreme Court. The New York state radiologist is facing 36 misdemeanor counts for secret sexual recording without consent, according to a story in the Boston Herald.
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Cardiologist charged with multiple counts of sexual assault—police say there may be more victims

Share on Twitter Share on Facebook Share on Linkedin
The long legal saga of Richard Paulus, a Kentucky cardiologist accused of performing unnecessary cardiac procedures, appears to still be going strong in 2022 and might be reviewed by the Supreme Court. The New York state radiologist is facing 36 misdemeanor counts for secret sexual recording without consent, according to a story in the Boston Herald.
The doctor was charged with three counts of sexual assault related to an alleged date rape from January. A preliminary hearing has been scheduled for May. 
READ MORE >

Damar Hamlin, now cleared for NFL return, shares the cause of his on-the-field cardiac arrest

 “This event was life-changing, but it is not the end of my story,” Hamlin said during a press conference. 

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Damar Hamlin discusses his NFL return following sudden cardiac arrest
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Damar Hamlin, now cleared for NFL return, shares the cause of his on-the-field cardiac arrest

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Damar Hamlin discusses his NFL return following sudden cardiac arrest
 “This event was life-changing, but it is not the end of my story,” Hamlin said during a press conference. 
READ MORE >

In Case You Missed It

AI predicts the likelihood of a common TAVR complication

Many patients still require a permanent pacemaker following TAVR. In fact, it is more common after TAVR than after surgical aortic valve replacement. 

READ MORE >
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AI predicts the likelihood of a common TAVR complication

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Many patients still require a permanent pacemaker following TAVR. In fact, it is more common after TAVR than after surgical aortic valve replacement. 
READ MORE >

TAVR vs. SAVR in patients with pure aortic regurgitation: Key insights from a new Cleveland Clinic study

Patients with pure native AR are often excluded from clinical trials comparing TAVR and SAVR, leading to a lack of clarity when it comes to the proper treatment of this population.

READ MORE >
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TAVR vs. SAVR in patients with pure aortic regurgitation: Key insights from a new Cleveland Clinic study

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Patients with pure native AR are often excluded from clinical trials comparing TAVR and SAVR, leading to a lack of clarity when it comes to the proper treatment of this population.
READ MORE >

In Other News

DOJ targets COVID-related healthcare fraud

One official described it as the 'largest-ever coordinated law enforcement action' of its kind.

READ MORE >
a pile of covid tests
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DOJ targets COVID-related healthcare fraud

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a pile of covid tests
One official described it as the 'largest-ever coordinated law enforcement action' of its kind.
READ MORE >

GE Healthcare solution, billed as a 'unified approach to patient monitoring,' gains FDA clearance

GE Healthcare received clearance from the U.S. Food and Drug Administration (FDA) for its patient monitoring platform, Carescape Canvas.

READ MORE >
patient.jpg
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GE Healthcare solution, billed as a 'unified approach to patient monitoring,' gains FDA clearance

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patient.jpg
GE Healthcare received clearance from the U.S. Food and Drug Administration (FDA) for its patient monitoring platform, Carescape Canvas.
READ MORE >

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