IMPELLA AND SHOCK WAVE, SECURITY ALERT, RISK OF OPTICAL SENSOR DAMAGE (+)

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Impella security alert, risk of optical sensor damage when shockwave is used.

 

In the recent years, intravascular lithotripsy has emerged as a new technique for coronary calcified plaque modification. 

 

It generates circumferential sonic pressure waves to fracture both surface and deep calcifications in the vessel wall, while limiting injury to the soft tissues.
 

In september 2024 Abiomed issued a security alert regarding the Impella support when coronary Shockwave is used for percutaneous coronary intervention.

 

The company has identified a risk of optical sensor damage when used concurrently in close proximity with Shockwave Coronary IVL Catheter.  

 

This alert affects the Impella CP and Impella 5.5 devices.

 

More info in the following video: 

 


 

Shockwave Coronary IVL catheter

Fig: Shockwave Coronary IVL catheter. 


Impella optical pressure sensor

 

Placement signal not reliable alarm

 

Image

 

 

 

 Tags: impella,shockwave,alert,security,damage,intravascular lithotripsy,plaque modification,calcification,percutaneous coronary intervention,risk,optical sensor,impella cp,impella 5.5,Shockwave Coronary IVL Catheter,Placement Signal Not Reliable,alarm,distance,support,flow,monitoring,position