Innovative Health, Inc. announced it has received U.S. Food and Drug Administration (FDA) clearance to reprocess St. Jude’s Advisor HD Grid Mapping Catheter.
With this clearance, the company—which also offers St. Jude’s Advisor FL and VL Mapping Catheters—becomes the only company that can reprocess all major mapping catheters from the market’s key providers: Biosense Webster (Pentaray, Lasso, Decanav), Medtronic (Achieve), and St. Jude (Advisor).
“Innovative Health’s clearances to reprocess all dominant St. Jude mapping catheters represent a milestone in single-use device reprocessing, as we can now help EP labs unlock significantly more savings per procedure by using reprocessed mapping catheters, regardless of the lab’s brand choice,” said Innovative Health CEO Rick Ferreira.
Innovative Health’s latest FDA clearance is particularly noteworthy because the Advisor HD Grid is a technologically advanced, sensor-enabled catheter—a complex technology requiring specialized protocols for reprocessing. The clearance also demonstrates the company’s ability to receive reprocessing clearance early in technology lifecycles, so that hospitals can adopt new technologies without compromising the economic sustainability of EP procedures.
The Advisor HD Grid represents Innovative Health’s 35th reprocessing clearance since 2016 and its third in just over a month. Other reprocessors have only a few clearances to reprocess the complex mapping catheters.
“Despite the trying economic landscape of 2020, Innovative Health remains committed to advancing the field of electrophysiology and opening up important procedures to more patients by helping EP labs increase their savings, no matter the technology their doctors prefer,” Ferreira added. “Innovative Health has gained more FDA clearances than any other reprocessor in recent years, and we’re not planning to slow down one bit.”