KARL STORZ Receives FDA Clearance for TIPCAM1 Rubina in Select Cardiac Surgical Procedures

Advanced 4K 3D and NIR/ICG visualization technology now available to support minimally invasive cardiac surgical care

EL SEGUNDO, Calif.--(BUSINESS WIRE)--KARL STORZ, a global leader in advanced surgical visualization and integrated operating room solutions, today 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.

TIPCAM1™ Rubina™ combines 4K visualization, stereoscopic 3D imaging, and near-infrared fluorescence imaging (NIR/ICG) 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.

The expanded indication broadens access to these advanced imaging capabilities for surgeons performing a variety of complex cardiac interventions, including but not limited to 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.

“Minimally invasive cardiac procedures require exceptional visualization and spatial awareness," said Fernando Morales, Vice President, Sales & Marketing, Surgical & OR1, KARL STORZ North America. "This expanded indication reinforces our 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."

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 OR technology.

About KARL STORZ

KARL STORZ is an innovative leader in endoscopic technology and surgical imaging across virtually all surgical specialties. Its integrated OR solutions enhance collaboration to improve clinical efficiency and outcomes inside the hospital and other sites of care. With subsidiaries around the world, KARL STORZ is a family-owned company based in Germany that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness. For more information, visit www.karlstorz.com.