FDA Clears Centerline Biomedical’s IOPS Viewpoint Catheter

Centerline Biomedical has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its IOPS Viewpoint Catheter, the newest addition to its patented IOPS (Intra-Operative Positioning System) portfolio.
 
The low-profile, 6 Fr catheter offers 3D navigation feedback. When Viewpoint Catheters are used with the IOPS software algorithms, endovascular tools can be visualized in real-time and clinicians can depend less on fluoroscopy systems, according to the company.
 
The image-guided, real-time navigation aims to revolutionize how endovascular procedures are done. It also lowers exposure to radiation emitted from X-ray fluoroscopy systems typically used to see vessels during these surgeries.
 
“Development of our second-generation portfolio for IOPS has been the top priority for Centerline Biomedical. Viewpoint Catheters were developed with input from leading clinicians to best meet their procedure needs,” said Gulam Khan, CEO of Centerline Biomedical. “Our company continues to reenvision the field of endovascular interventions developing technologies designed with the express purpose of improving outcomes for both providers and patients.”
 
IOPS is FDA-cleared for use in the descending aorta. The company said it’s continuing investment to boost the current technology platform and expand image guidance in transcatheter procedures.
 
Centerline released its IOPS V1.4 software in June. The latest software includes usability enhancements like improved isolation and Torus, Sphere, and Line Annotations placed in any workflow.