ŌNŌCOR’s ŌNŌ Retrieval System Used for Percutaneous Removal of an Intracardiac Tumor in FIH Procedure

August 2, 2022—ŌNŌCOR LLC announced the first-in-human (FIH) use of the ŌNŌ endovascular retrieval system for removal of an intracardiac tumor. James M. McCabe, MD, and Zachary L. Steinberg, MD, and their team performed the procedure at the University of Washington (UW) Medical Center in Seattle, Washington.

According to the company, the ŌNŌ device is designed to receive, align, compress, and remove material (nonbiologic and biologic) from the vascular system. ŌNŌ is intuitive to use and is compatible with commercially available vascular sheaths, endovascular snares, and other graspers, noted the company.

ŌNŌ received FDA clearance in May 2022. The device is available at select sites throughout the United States. The ŌNŌ retrieval device is indicated for use in the cardiovascular system to retrieve foreign objects using minimally invasive procedures, advised the company.

In the procedure at UW, Dr. McCabe, Dr. Steinberg, and colleagues used the ŌNŌ system in combination with electrocautery to percutaneously snare, resect, and remove a cardiac fibromyxoma from the right atrium of the patient.

“Intracardiac tumors are a vexing problem and present a management dilemma for physicians,” commented Dr. McCabe in ŌNŌCOR's press release. “These tumors are often found incidentally by echocardiography at relatively small sizes. However, rather than subjecting patients to elective surgical removal, these masses are typically followed expectantly until they increase in size to a point where they are physiologically problematic. At that point, the risks of open-heart surgery are deemed justifiable.”

Dr. McCabe, who is Section Chief of Interventional Cardiology at UW, continued, “Obviously it would be best to remove these tumors before they cause problems, but until now, there were no reliable nonsurgical options. The approach that we developed here at UW involved using the ŌNŌ to secure the highly mobile fibromyxoma within the ŌNŌ basket. Once the mass was separated from the myocardium by means of electrocautery, it was easily compressed by the ŌNŌ and removed from the body.”