Innovative Health's proprietary method for detecting subvisible particles within microlumens has helped the company obtain clearance to reprocess complex electrophysiology devices while paving the way for continued industry-defining innovation.
Innovative Health, Inc. announced it has received the first-ever U.S. patent for a microlumen reprocessing technology, a milestone in ensuring patient safety while advancing the vital discipline of reprocessing single-use cardiology medical devices. The patent (US Patent 10,830,682), which covers a novel test method for identifying subvisible occluding particles in microlumens, grants Innovative Health a significant competitive edge when it comes to reprocessing complex electrophysiology (EP) devices and paves the way for future innovation in the field by the company.
The testing method covered by the new patent was the result of many months of dialogue between Innovative Health and the FDA that resulted in a new standard for ensuring the safe reprocessing of EP devices containing microlumens.
"Re-using medical devices is a serious endeavor that requires the utmost attention to patient safety," said Aaron Fowler, Sr. R&D Engineer, Head of Emerging Technologies at Innovative Health. "To date, other reprocessors have focused on showing that reprocessed devices are clean. At Innovative Health, as we move into reprocessing more complex — and thus, more expensive — EP devices, we're focused on demonstrating that the reprocessed devices are not only clean, but also clear. To do that, we had to work with FDA to develop an entirely new standard for detecting occlusions that elevates patient safety standards for reprocessed devices going forward."
The patented testing method is currently being leveraged by Innovative Health for the reprocessing of the Reprocessed PentaRay Nav Eco High-Density Mapping Catheter (Biosense Webster), the Reprocessed Advisor HD Grid Mapping Catheter (St. Jude Medical), the Reprocessed BRK Transseptal Needle (St. Jude Medical) and the Reprocessed NRG Transseptal Needle (Baylis Medical).
Importantly, it also sets the stage for continued advances that will push EP device reprocessing forward, both in terms of innovation and patient safety: Innovative Health is building a patent portfolio to expand the ability of EP labs to reduce costs without sacrificing quality and safety. The company's expanding intellectual property portfolio will clear the path to push reprocessing of devices outside of the EP lab to adjacent technologies within cardiology.
"This patent sets a new bar for all reprocessors to improve their testing methods and ensure patient safety going forward," said Innovative Health CEO Rick Ferreira. "And we're not resting on our laurels at Innovative Health. We continue to look at new testing and reprocessing methods that will improve hospital access to more-affordable medical devices while also increasing physician comfort level with reprocessed devices due to the elevated level of rigor being applied to their handling."
About Innovative Health
Innovative Health is an advanced medical device reprocessing company that offers smarter utilization of medical devices in hospitals' cardiology and electrophysiology programs.