Innovative Health said today that it has received FDA clearance to reprocess the Biosense Webster PentaRay Nav eco high-density mapping catheter for reuse.
The clearance is the latest allowing Scottsdale, Ariz.-based Innovative Health to reprocess catheters. The FDA cleared it in 2018 to reprocess St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav diagnostic catheters. The company also has FDA clearances to reprocess several ultrasound catheters, including the ViewFlex Xtra by St. Jude and all models of the Biosense Webster’s Soundstar and Acunav ultrasound catheters.
The PentaRay is a key medical device in atrial fibrillation (AF) procedures, one of the fastest growing and most expensive procedures in hospitals today, according to Innovative Health. Hospitals using the reprocessed PentaRay and other expensive single-use labeled cardiology devices can save thousands of dollars on each AF procedure, potentially opening the procedure up for more patients, the company said.
The PentaRay cardiology mapping catheter can do high-resolution mapping and cover all four chambers of the heart, which the manufacturer associates with reduced procedure and fluoroscopy time. The device was difficult to reprocess in the past because it contains microlumen technology (channels the size of a human hair), and an FDA clearance requires cleaning and testing access to all areas of the device.
Innovative Health collaborated with the FDA through the pre-submission process to seek the agency’s guidance on appropriate test methods for reprocessing this device. The company then created new protocols and standards to remove blood and Heparin from the microlumen, and testing to ensure that these efforts were effective. The company said that the new standards and processes used to reprocess the PentaRay will allow Innovative Health to reprocess other similar devices using microlumen technology, which is becoming dominant in AF ablation procedures.
“With the clearance to reprocess PentaRay, we have achieved two important things,” said Innovative Health CEO Rick Ferreira in a news release. “We have made it possible for hospitals to reduce AF ablation medical device costs by as much as 30%, and we have demonstrated that reprocessing engineering can break boundaries traditionally considered to be unbreakable. We will continue to work with hospital cardiology units, FDA and clinicians to expand cardiology reprocessing, so that these procedures can become economically viable, and therefore more successful and more widely available, while always keeping patient safety as our top priority.”