Diagnostic Ultrasound Catheters
Stryker, the nation's leading provider of reprocessed diagnostic ultrasound catheters, has numerous FDA clearances for a product offering that includes several diagnostic ultrasound catheter models. To obtain these clearances, Stryker must submit validation data to FDA that demonstrate cleanliness, sterility and functional performance. Numerous performance and electrical safety tests are conducted on reprocessed catheters to ensure our partners receive safe, functional devices for use. Through reprocessing, Stryker allows hospitals and surgery centers to realize substantial supply costs savings and reduce environmental harm while improving quality of care.
Technical Summary:
Diagnostic Ultrasound Catheters provide two-dimensional imaging using an ultrasound transducer, located at the distal tip of the catheter. The ultrasound transducer can be positioned for ultrasound imaging using a steering mechanism that rotates the catheter tip and variable deflection. Diagnostic ultrasound catheters are available in two sizes: 10 French (90 cm insertion length) or 8 French (110 cm insertion length). Reprocessed diagnostic ultrasound catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as for viewing other devices in the heart. Stryker’s reprocessed diagnostic ultrasound catheters are compatible with Siemens and GE ultrasound systems.
Reprocessed AcuNav ultrasound catheters are used in Cardiac Cath lab and Electrophysiology (EP) lab for the visualizion of Intracardiac and Intraluminal cardiac structures and grade vessel anatomy and physiology, to view the placement of other devices and measure blood flow in catheter ablations and closures.
Stryker’s reprocessed 3D diagnostic ultrasound catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well for viewing other devices in the heart. The 3D diagnostic ultrasound catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.
Reprocessed SOUNDSTAR™ 3D Diagnostic Ultrasound Catheters are Intra Cardiac Echo (ICE) catheters, capable of providing two-dimensional imaging using an ultrasound transducer and three-dimensional location information using a location sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can be positioned for ultrasound imaging and 3D mapping through a steering mechanism that rotates the catheter tip to variable deflections. The location sensor provides location information to the CARTO® XP EP Navigation System (mapping system). The 3D Diagnostic Ultrasound Catheter is 10 French (90 cm insertion length).
Stryker reprocesses Diagnostic ultrasound catheters originally manufactured by Biosense Webster (J&J), sold under the AcuNav and SoundStar trade names.