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Recor Medical gains historic approval | GE HealthCare launches new ultrasound tech | Sedation vs. local anesthesia during TAVR

News You Need to Know Today
Recor Medical gains historic approval | GE HealthCare launches new ultrasound tech | Sedation vs. local anesthesia during TAVR
Tuesday, September 2, 2025
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Today's News and Trends

Recor Medical gains historic approval for its ultrasound RDN system

Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.

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The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
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Recor Medical gains historic approval for its ultrasound RDN system

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The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.
READ MORE >

GE HealthCare launches ‘ultra-premium’ Vivid Pioneer cardiovascular ultrasound system

The company describes Vivid Pioneer as its “most advanced, ultra-premium and adaptive cardiovascular ultrasound system yet.” It includes new and improved AI capabilities and a compact design that is still fully functional in tight workspaces. 

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GE HealthCare Vivid Pioneer cardiovascular ultrasound
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GE HealthCare launches ‘ultra-premium’ Vivid Pioneer cardiovascular ultrasound system

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GE HealthCare Vivid Pioneer cardiovascular ultrasound
The company describes Vivid Pioneer as its “most advanced, ultra-premium and adaptive cardiovascular ultrasound system yet.” It includes new and improved AI capabilities and a compact design that is still fully functional in tight workspaces. 
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No sedation required: Local anesthesia enough for most TAVR patients

New data out of ESC Congress 2025 suggest care teams can take a more minimalist approach during a majority of TAVR cases and only treat patients with local anesthesia. In some cases, however, sedation will still be necessary. 

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No sedation required: Local anesthesia enough for most TAVR patients

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New data out of ESC Congress 2025 suggest care teams can take a more minimalist approach during a majority of TAVR cases and only treat patients with local anesthesia. In some cases, however, sedation will still be necessary. 
READ MORE >

Abbott receives expanded approval for Navitor TAVR system

Abbott's TAVR valve now has CE mark approval for treating low-, intermediate- and high-risk patients who present with symptomatic severe aortic stenosis. The news comes as new data on the valve's safety and effectiveness were just published in JACC: Cardiovascular Interventions.

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Abbott's Navitor TAVR valve
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Abbott receives expanded approval for Navitor TAVR system

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Abbott's Navitor TAVR valve
Abbott's TAVR valve now has CE mark approval for treating low-, intermediate- and high-risk patients who present with symptomatic severe aortic stenosis. The news comes as new data on the valve's safety and effectiveness were just published in JACC: Cardiovascular Interventions.
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Featured Articles

Medtronic receives updated FDA approval for redo TAVR

The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.

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Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The larger coronary access window in the frame of the Evolut FX+. Image courtesy of Medtronic.
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Medtronic receives updated FDA approval for redo TAVR

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Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The larger coronary access window in the frame of the Evolut FX+. Image courtesy of Medtronic.
The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.
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Johnson & Johnson MedTech hit with permanent injunction as fallout over antitrust lawsuit continues

Johnson & Johnson MedTech was already ordered to pay $442.2 million in damages for withholding clinical support to healthcare providers. Now the company has been hit with a permanent injunction designed to stop it from being a repeat offender.

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judge court gavel justice system legal
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Johnson & Johnson MedTech hit with permanent injunction as fallout over antitrust lawsuit continues

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judge court gavel justice system legal
Johnson & Johnson MedTech was already ordered to pay $442.2 million in damages for withholding clinical support to healthcare providers. Now the company has been hit with a permanent injunction designed to stop it from being a repeat offender.
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Old age, RBBB help predict when TTVR patients may require a permanent pacemaker

Though just a small, single-facility study, these findings help care teams know what to look for when performing transcatheter tricuspid valve replacement.

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Edwards Lifesciences gained European CE mark approval for Evoque transcatheter tricuspid valve replacement (TTVR) system.
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Old age, RBBB help predict when TTVR patients may require a permanent pacemaker

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Edwards Lifesciences gained European CE mark approval for Evoque transcatheter tricuspid valve replacement (TTVR) system.
Though just a small, single-facility study, these findings help care teams know what to look for when performing transcatheter tricuspid valve replacement.
READ MORE >

In Case You Missed It

Medtech company raises $32M for foam-based LAAO device

New Hampshire-based Conformal Medical plans on using the funds to enroll more patients into an ongoing clinical trial. 

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Conformal Medical CLAAS
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Medtech company raises $32M for foam-based LAAO device

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Conformal Medical CLAAS
New Hampshire-based Conformal Medical plans on using the funds to enroll more patients into an ongoing clinical trial. 
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Lipoprotein(a) tests could transform patient care—is it time for universal screening?

"Lp(a) represents the most important potential potential paradigm shift in cardiovascular disease prevention that we'll experience over the next five to 10 years," Seth Baum, MD, explained in a new interview.

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Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, Chairman of the Board for the Family Heart Foundation, past president of the American Society for Preventive Cardiology, clinical affiliate professor of biomedical science at Florida Atlantic University, and chief medical officer of Flourish Research, explains why testing for familial hypercholesterolemia (FH) and elevated Lipoprotein(a) could be critical to identify more patients with elevated risk of cardiac events, but have their LDL well controlled.
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Lipoprotein(a) tests could transform patient care—is it time for universal screening?

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Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, Chairman of the Board for the Family Heart Foundation, past president of the American Society for Preventive Cardiology, clinical affiliate professor of biomedical science at Florida Atlantic University, and chief medical officer of Flourish Research, explains why testing for familial hypercholesterolemia (FH) and elevated Lipoprotein(a) could be critical to identify more patients with elevated risk of cardiac events, but have their LDL well controlled.
"Lp(a) represents the most important potential potential paradigm shift in cardiovascular disease prevention that we'll experience over the next five to 10 years," Seth Baum, MD, explained in a new interview.
READ MORE >

Coronary sinus reducer linked to improvements in patients with refractory angina—but questions remain

Treatment with the device is consistently safe, but researchers still think more data is required before reaching any conclusions about its efficacy. 

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coronary sinus reducer shockwave medical
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Coronary sinus reducer linked to improvements in patients with refractory angina—but questions remain

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coronary sinus reducer shockwave medical
Treatment with the device is consistently safe, but researchers still think more data is required before reaching any conclusions about its efficacy. 
READ MORE >

In Other News

FDA changes imaging recommendations for patients taking popular Alzheimer's drug

Leqembi (lecanemab) was approved by the FDA in 2023. It is an infusion drug that has been shown to reduce Alzheimer’s-related cognitive decline by up to 27%. 

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FDA changes imaging recommendations for patients taking popular Alzheimer's drug

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Leqembi (lecanemab) was approved by the FDA in 2023. It is an infusion drug that has been shown to reduce Alzheimer’s-related cognitive decline by up to 27%. 
READ MORE >

Changing course: Healthcare AI systems are leaving clinicians behind

A new analysis published in Artificial Intelligence in Medicine argues that education tools are failing to show clinicians how to make use of new technologies, calling into question the benefit of rapid adoption. 

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night school adult education
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Changing course: Healthcare AI systems are leaving clinicians behind

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night school adult education
A new analysis published in Artificial Intelligence in Medicine argues that education tools are failing to show clinicians how to make use of new technologies, calling into question the benefit of rapid adoption. 
READ MORE >

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