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News You Need to Know Today
Week in Review: FDA's heart pump warning | Medtronic to acquire CathWorks | J&J devices recalled | Comparing CABG strategies
Saturday, February 7, 2026
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This Week’s News

FDA warns that Johnson & Johnson heart pump sensors may malfunction—22 injuries reported

There is a risk of users making adjustments during treatment that are unnecessary. The FDA is still evaluating the issue at this time.

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The Impella RP with SmartAssist. Image courtesy of Johnson & Johnson MedTech.
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FDA warns that Johnson & Johnson heart pump sensors may malfunction—22 injuries reported

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The Impella RP with SmartAssist. Image courtesy of Johnson & Johnson MedTech.
There is a risk of users making adjustments during treatment that are unnecessary. The FDA is still evaluating the issue at this time.
READ MORE >

Medtronic to acquire AI-enabled FFR specialists CathWorks for up to $585M

Medtronic has held a minority investment in CathWorks for several years, and the two organizations entered into a co-promotion agreement in 2022. Once finalized, the move will increase Medtronic's presence in the cath lab. 

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artificial intelligence money finance acquisition
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Medtronic to acquire AI-enabled FFR specialists CathWorks for up to $585M

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artificial intelligence money finance acquisition
Medtronic has held a minority investment in CathWorks for several years, and the two organizations entered into a co-promotion agreement in 2022. Once finalized, the move will increase Medtronic's presence in the cath lab. 
READ MORE >

FDA shares update about CGM sensor recalls—issue now linked to 860 serious injuries

Abbott first warned the public about this problem in November. Now, for the second time in less than a month, the FDA is providing additional details. 

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Abbott FreeStyle Libre 3 CGM
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FDA shares update about CGM sensor recalls—issue now linked to 860 serious injuries

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Abbott FreeStyle Libre 3 CGM
Abbott first warned the public about this problem in November. Now, for the second time in less than a month, the FDA is providing additional details. 
READ MORE >

IVL may be safer than atherectomy in patients with severely calcified lesions

Researchers explored data from more than 1,000 patients with calcified coronary artery disease who required plaque modification. IVL and atherectomy were linked to comparable success rates, but adverse events were less likely with IVL.

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The use of intravascular lithotripsy (IVL) during percutaneous coronary intervention (PCI) is still safe and effective when patients present with calcified nodules (CNs), according to new long-term data published in EuroIntervention.[1] Researchers compared outcomes from patients with and without CNs, highlighting key similarities in stent expansion and luminal gain.
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IVL may be safer than atherectomy in patients with severely calcified lesions

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The use of intravascular lithotripsy (IVL) during percutaneous coronary intervention (PCI) is still safe and effective when patients present with calcified nodules (CNs), according to new long-term data published in EuroIntervention.[1] Researchers compared outcomes from patients with and without CNs, highlighting key similarities in stent expansion and luminal gain.
Researchers explored data from more than 1,000 patients with calcified coronary artery disease who required plaque modification. IVL and atherectomy were linked to comparable success rates, but adverse events were less likely with IVL.
READ MORE >

FDA announces recall of Johnson & Johnson devices after multiple injuries, 1 death

Several detachable coil systems are being recalled due to a higher-than-expected failure to detach rate. Customers should not use them going forward.

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Cerepak Detachable Coil Systems
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FDA announces recall of Johnson & Johnson devices after multiple injuries, 1 death

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Cerepak Detachable Coil Systems
Several detachable coil systems are being recalled due to a higher-than-expected failure to detach rate. Customers should not use them going forward.
READ MORE >

Comparable long-term survival seen in two common CABG strategies

STS late-breaking study found BITA and SITA+RA have similar long-term survival, but age plays a role in which to choose.

READ MORE >
CABG coronary artery bypass grafting heart surgery
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Comparable long-term survival seen in two common CABG strategies

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CABG coronary artery bypass grafting heart surgery
STS late-breaking study found BITA and SITA+RA have similar long-term survival, but age plays a role in which to choose.
READ MORE >

Interventional cardiologists implant new-look heart device for first time in US

The Amend device from Valcare Medical has a closed ring shape similar to the annuloplasty rings used to treat MR during open-heart surgeries. These early patients will be followed for a total of five years.

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Valcare Medical’s Amend Transseptal System for mitral regurgitation
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Interventional cardiologists implant new-look heart device for first time in US

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Valcare Medical’s Amend Transseptal System for mitral regurgitation
The Amend device from Valcare Medical has a closed ring shape similar to the annuloplasty rings used to treat MR during open-heart surgeries. These early patients will be followed for a total of five years.
READ MORE >

Nasal spray for paroxysmal supraventricular tachycardia enters US market

New drug allows patients to self-treat PSVT. About 2 million people in the U.S. have been diagnosed with condition.

READ MORE >
New data from the Phase 3 RAPID clinical trial of etripamil, an investigational calcium channel blocker nasal spray, showed positive results in converting paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm in the at-home setting. The presentation was featured during a late-breaking clinical trials session at the American Heart Association (AHA) 2022 Scientific Sessions. #AHA22
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Nasal spray for paroxysmal supraventricular tachycardia enters US market

Share on Twitter Share on Facebook Share on Linkedin
New data from the Phase 3 RAPID clinical trial of etripamil, an investigational calcium channel blocker nasal spray, showed positive results in converting paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm in the at-home setting. The presentation was featured during a late-breaking clinical trials session at the American Heart Association (AHA) 2022 Scientific Sessions. #AHA22
New drug allows patients to self-treat PSVT. About 2 million people in the U.S. have been diagnosed with condition.
READ MORE >

Medtronic SVP Nina Goodheart to retire after nearly 20 years in cardiovascular care

Nina Goodheart, the president of Medtronic’s structural heart and aortic business, has announced her retirement. 

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Nina Goodheart Medtronic to retire
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Medtronic SVP Nina Goodheart to retire after nearly 20 years in cardiovascular care

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Nina Goodheart Medtronic to retire
Nina Goodheart, the president of Medtronic’s structural heart and aortic business, has announced her retirement. 
READ MORE >

Key trends in transcatheter tricuspid valve repair and replacement

The interventional treatment of tricuspid valve disease has evolved in recent years thanks to new research and critical FDA approvals. Cardiologist Ryan Kaple, MD, reviewed this trend for a new video interview.

READ MORE >
Transcatheter treatment of tricuspid valve disease has rapidly evolved over the past two years, giving physicians new tools to address a condition long considered under treated due to limited procedural options and complex anatomy. Ryan K. Kaple, MD, FACC, FSCAI, director of the structural and congenital heart program at Hackensack University Medical Center, spoke top Cardiovascular Business about recent advances and his center's real-world experience.
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Key trends in transcatheter tricuspid valve repair and replacement

Share on Twitter Share on Facebook Share on Linkedin
Transcatheter treatment of tricuspid valve disease has rapidly evolved over the past two years, giving physicians new tools to address a condition long considered under treated due to limited procedural options and complex anatomy. Ryan K. Kaple, MD, FACC, FSCAI, director of the structural and congenital heart program at Hackensack University Medical Center, spoke top Cardiovascular Business about recent advances and his center's real-world experience.
The interventional treatment of tricuspid valve disease has evolved in recent years thanks to new research and critical FDA approvals. Cardiologist Ryan Kaple, MD, reviewed this trend for a new video interview.
READ MORE >

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