Centerline Biomedical, Inc., a Cleveland-based innovator in cardiovascular navigation technology, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded indications of its Intra-Operative Positioning System (IOPS). This regulatory milestone significantly broadens the platform's clinical applications and market potential.
The expanded clearance allows IOPS to be used in peripheral, aortic, and aortic side branch vasculature procedures. Additionally, the FDA has cleared the IOPS Fiducial Tracking Pad, a second-generation lower-profile device that further extends the platform's capabilities.
"With this clearance, our ground-breaking, image guidance technology, IOPS can be utilized across a larger market opportunity in new and expanded clinical applications," said Gulam Khan, CEO of Centerline Biomedical. "We are thrilled to be able to introduce more clinicians to IOPS. In tandem, Centerline continues to aspire to improve image guidance, reduce radiation exposure inherent with x-ray-based imaging, and offer a safer procedure environment for patients and clinicians."
Neurovascular Applications
The expanded indication is particularly significant for neurovascular procedures, according to experts in the field. Dr. Peter Rasmussen, Neurosurgeon in the Cerebrovascular Center and Professor of Neurosurgery at The Cleveland Clinic, highlighted the potential impact: "The expanded indication promises to open IOPS to neuro endovascular physicians and the neurovasculature. This may be useful to help solve neurovascular access problems during all cerebrovascular interventions, particularly during acute stroke intervention via greater visualization of the anatomy."
Reducing Radiation Exposure
Conventional endovascular procedures rely heavily on fluoroscopy—continuous X-ray imaging—to visualize anatomy and guide instruments within blood vessels. This approach exposes both patients and medical staff to significant radiation, which can accumulate over time and potentially lead to DNA damage and other medical complications.
IOPS addresses this concern by minimizing the need for prolonged fluoroscopy. The system leverages diagnostic imaging data already captured during pre-procedure planning to create detailed, multi-color 3D vascular maps. These interactive visualizations provide superior anatomical detail compared to traditional 2D grayscale X-ray fluoroscopy.
Advanced Visualization Technology
The IOPS platform transforms existing patient scans into comprehensive 3D maps that can be viewed from multiple angles during procedures. These visualizations highlight critical vascular features that are often difficult to discern with conventional imaging, including:
- Calcifications
- Occlusions
- Dissections
- Soft tissue formations
During interventions, the system tracks specialized sensorized guidewires and catheters in real-time, allowing precise navigation through complex vasculature while reducing dependence on radiation-based imaging.
Clinical Impact and Future Directions
The expanded clearance positions IOPS as an increasingly versatile tool across a broader range of endovascular procedures. For neurovascular applications specifically, the technology may prove particularly valuable in acute stroke interventions, where rapid and precise navigation through cerebral vessels is critical for successful outcomes.
The IOPS platform is indicated as an adjunct to fluoroscopy rather than a complete replacement, maintaining compatibility with existing clinical workflows while offering enhanced visualization capabilities.
Centerline Biomedical continues to invest in further development of the IOPS platform, with ongoing efforts to enhance the current technology and expand its applications in minimally invasive procedures. The company, founded in 2015, maintains its headquarters in Cleveland, Ohio, where it continues to advance its mission of improving image guidance in endovascular interventions.
