ŌNŌCOR’s ŌNŌ Retrieval System Used to Remove Large Atrial Thrombus in FIH Percutaneous Procedure

August 25, 2022—ŌNŌCOR LLC announced the first-in-human (FIH) use of the ŌNŌ endovascular retrieval system to remove a large central-line-associated thrombus from the right atrium in an adolescent patient. The large fibrotic thrombus was percutaneously removed from the patient using a combination of ŌNŌ, endovascular snares, and electrocautery.

Darren Berman, MD, led the team that performed the procedure at Children’s Hospital Los Angeles (CHLA) in Los Angeles, California. Dr. Berman is Director of Congenital Interventional Catheterization with CHLA’s Heart Institute.

“This procedure was inspired by the SEATtLE procedure recently performed at the University of Washington and represents the first time that a large hemodynamically problematic thrombus was captured and removed nonsurgically, and without fragmentation or distal embolization of particulate matter,” commented Dr. Berman in the ŌNŌCOR press release. “The ŌNŌ was key to securing the mobile mass and subsequently removing it from the vasculature atraumatically.”

SEATtLE is an acronym for Simplified Extraction of Atrial Tumor with Targeted Loop Electricity. On August 2, the company announced that the FIH use of the ŌNŌ system for removal of an intracardiac tumor was performed by James M. McCabe, MD, and Zachary L. Steinberg, MD, at the University of Washington Medical Center in Seattle, Washington.

Dr. Berman further stated in the press release, “Intra-atrial thrombus formation associated with indwelling central lines is a common problem. Typically, the approach is to treat with anticoagulants in the hopes that the clot reabsorbs. When this doesn’t work, and the thrombus burden remains substantial, it represents an ongoing risk for pulmonary and systemic emboli. Our patient today is representative of a clinical dilemma that we often face. Up until this point, the only options that we had were ‘watchful waiting’ or open heart surgery.”

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

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