KARL STORZ Receives FDA Clearance for TIPCAM1 Rubina in Cardiac Surgery
KARL STORZ has announced that the U.S. Food and Drug Administration (FDA) has cleared expanded indications for the TIPCAM1 Rubina video endoscope for use in selected cardiac surgical procedures. The clearance broadens access to the system’s advanced imaging capabilities for surgeons performing complex cardiac interventions, including mitral valve repair and replacement, tricuspid valve repair, internal mammary artery mobilization for cardiac revascularization, and structural heart interventions such as left atrial appendage closure or occlusion.
TIPCAM1 Rubina combines 4K visualization, stereoscopic 3D imaging, and near-infrared fluorescence imaging in a single video endoscope, helping surgeons visualize anatomy with enhanced depth perception and clarity during minimally invasive procedures. The system’s Horizon Control technology automatically maintains image orientation as the scope is rotated, supporting visualization consistency and workflow efficiency.
TIPCAM1 Rubina is already used across a broad range of minimally invasive procedures, including general surgery, gynecology, urology, colorectal surgery, bariatric surgery, hepatobiliary surgery, and thoracic surgery. The expanded cardiac indication further extends the platform’s applicability across surgical specialties.
The TIPCAM1 Rubina is part of the KARL STORZ IMAGE1 S platform, a modular visualization ecosystem designed to support a broad range of surgical specialties. The scalable architecture of IMAGE1 S enables healthcare facilities to further advance their imaging capabilities while maximizing existing investments in operating room technology.
Fernando Morales, Vice President of Sales and Marketing for Surgical and OR1 at KARL STORZ North America, said minimally invasive cardiac procedures require exceptional visualization and spatial awareness. Morales noted that the expanded indication reinforces the company’s commitment to advancing surgical care by equipping cardiac surgeons with technologies that support confident decision-making, precise tissue handling, and improved visualization of complex anatomy.
