Vein360 Receives FDA Clearances to Reprocess the Philips Digital IVUS Catheters

November 7, 2023—Vein360, an Ohio-based medical technology company focused on sustainable manufacturing of complex cardiovascular products, announced it received FDA 510(k) clearance to reprocess five intravascular ultrasound (IVUS) devices in recent months.

In 2023, the company received clearance to reprocess the following:

• Philips Visions PV .035 digital IVUS catheter (first announced in June 2023)
• Philips Visions PV .018 digital IVUS catheter
• Philips Visions PV .014P RX digital IVUS catheter
• Philips Eagle Eye Platinum RX digital IVUS catheter
• Philips Eagle Eye Platinum ST RX digital IVUS catheter

Christopher Meyer, MD, Cofounder and Chief Medical Officer of Vein360, commented in the company’s press release, “As independent endovascular physicians, our reimbursement for IVUS has eroded so much that we are often paid less than the cost of the catheter. This hurts our ability to work autonomously in our own office-based labs and ambulatory surgery centers.”

Dr. Meyer continued, “It was clear to us that the Philips IVUS with its phased-array transducers was easy to use and had superior image quality. Our goal in the submissions was to get this superior technology in the hands of physicians while allowing them to maintain profitability when performing IVUS. At Vein360, we will continue to work tirelessly to reduce procedural cost so that physicians can focus on patient care.”