Innovative Health Cleared to Reprocess VIZIGO BI-Directional Guiding Sheath

Innovative Health LLC, a specialty cardiology reprocessor, has received clearance to reprocess Biosense Webster’s VIZIGO BI-Directional Guiding Sheath.
 
Launched in 2018, the steerable guiding sheath can be visualized on Biosense Webster’s Carto 3 System during a catheter ablation procedure, which can help reduce the use of fluoroscopy.

Innovative Health has built a leading portfolio of FDA clearances to reprocess medical devices in the EP lab and has enabled EP labs across the country to reduce procedure device costs by as much as 30% without compromising patient safety or necessitating treatment adjustments. These savings are strategically important in many EP labs.

“EP labs often struggle to pay for new technologies such as the VIZIGO BI-Directional Guiding Sheath, which is significantly more costly than other guiding sheaths in the market. As a result, many labs today still do not use the sheath. The availability of a safe reprocessed version could allow more labs to use the leading technology,” said Innovative Health CEO Rick Ferreira. 
 
The relatively rapid clearance of VIZIGO BI-Directional Guiding Sheath for reprocessing demonstrates how reprocessing technology has advanced to a point where new, expensive technology can be accessed at a lower cost very early in the technology’s lifecycle.