Centerline Biomedical Inc, a pioneering force in cardiovascular navigation and visualization technology, has achieved the U.S. Food and Drug Administration’s (FDA) 510(k) clearance for their newly developed IOPS Guidewire Handle. This represents the latest addition to their unique and patented IOPS (Intra-Operative Positioning System) technology lineup.
The IOPS Guidewire Handle, when used in conjunction with its sensor-equipped IOPS Guidewire and novel viewpoint catheter, supports comprehensive 3D navigation within a patient’s vascular system. With the IOPS software’s specialized algorithms, clinicians gain the ability to visualize these devices in real-time, considerably reducing their reliance on fluoroscopy during treatments.
Traditionally, endovascular procedures involve the use of fluoroscopy, or live x-ray imaging, to track medical devices within the body. However, fluoroscopic procedures expose clinicians and medical staff to radiation, which over extended periods, can pose risks such as DNA damage and other health complications. The IOPS Guidewire Handle is engineered to minimize the necessity of fluoroscopy, enhancing safety for both medical professionals and their patients, thanks to advancements in device navigation and visualization.
Enhancements like the innovative Spintegration feature empower the IOPS Guidewire Handle with multicolor 3D visualization of arterial pathways during the placement of stent grafts. This advancement enables a superior method of vascular mapping, delivering dynamic 3D imagery that clarifies the intricate features of affected arteries, such as calcifications, occlusions, and dissections, which are less visible with conventional 2D gray-scale x-ray fluoroscopy. Furthermore, exclusive new software capabilities integrated into Centerline’s IOPS now enable the creation and visualization of 3D wireframe models of vessels, aiding procedural mapping.
“Centerline’s mission has always been to cater directly to the needs of clinicians. Our approach is continuously refined based on field experience,” shared Vikash Goel, founder and CTO. “The clearance of the IOPS Guidewire Handle coincides with the release of our next-generation viewpoint catheter and our sixth software upgrade. I am immensely proud of our innovative product development team, who remain committed to advancing the IOPS platform.”