Centerline Biomedical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its intra-operative positioning system (IOPS) Viewpoint Catheter.
The US-based firm received the regulatory clearance for using the IOPS platform in the descending aorta.
The Viewpoint Catheter is a low profile 6 French (Fr) device, available in various tip shapes and lengths. Designed to facilitate precise access, the device offers three-dimensional (3D) navigation feedback to clinicians.
It is the latest addition to Centerline Biomedical’s patented IOPS series.
The IOPS Viewpoint Catheter is intended to improve cardiovascular visualisation and navigation in endovascular procedures, shorten procedure times, and decrease overall radiation exposure.
It uses patented algorithms to create a patient-specific vascular map, integrating electromagnetic tracking and smart sensor-equipped surgical devices.
This technology delivers real-time, 3D colour visualisation and navigation of the human vascular system.
When paired with the IOPS software’s proprietary algorithms, the Viewpoint Catheter enables clear, real-time visualisation of endovascular tools. This also decreases dependency on fluoroscopy systems.
According to Centerline Biomedical, this image-guided navigation system transforms endovascular procedures by minimising exposure to harmful radiation typically emitted by x-ray fluoroscopy systems used to visualise vessels.
Centerline Biomedical CEO Gulam Khan said: “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.
“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.”
The medical technology firm plans to continue investing in the advancement of its technology platform to enhance existing features and broaden image guidance applications in transcatheter procedures.
The company, supported by Cleveland Clinic, GE Healthcare, and other investors, raised $33m in Series B equity financing in 2022.
