“Innovative Health's clearance for these devices highlights how we have listened to our customers’ needs, as transseptal needles will be a substantial contributor to reprocessing savings,” said Innovative Health CEO Rick Ferreira. “Such savings are more vital for hospitals than ever, given the financial challenges wrought by COVID-19 this year. By saving more on a per-procedure basis in the EP lab, hospitals can start to offset some of their losses in other departments.”
Transseptal needles are used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. These devices represent Innovative Health’s entrance into a new device technology and clinical application area, demonstrating the company’s commitment to advancing the EP space as a whole. To obtain these clearances, Innovative Health pioneered new reprocessing technology for evaluating sharpness, reprocessing a metal lumen, and addressing radiofrequency energy.
These FDA clearances further cement Innovative Health’s position in the cardiac device reprocessing space, where the company claims it has gained more recent FDA clearances than any other reprocessor in recent years.