The ŌNŌ works on a simple but precise mechanical principle: longitudinal force applied at the proximal end generates radial compressive force at the distal end — the same concept as a finger trap. As the Nitinol basket enters the retrieval sheath, it compresses and collapses around the target object, securing it for withdrawal. If the object is non-compressible, the basket captures and contains it, protecting surrounding anatomy during removal.
ŌNŌ Technology
Protect Your Cath Lab’s Efficiency and Case Throughput
The ŌNŌ Retrieval Device is an enabling technology designed to allow clinicians to plan beyond what was previously in reach. The ŌNŌ device is designed to receive, align, compress and remove material from the vascular system. It is compatible with commercially available vascular sheaths, endovascular snares and other graspers.
The 12F ŌNŌ retrieval device consists of a series of braided loops forming a basket fused to a 7.5F inner diameter catheter. A peel away sheath is preloaded over the ŌNŌ shaft which will assist in compression of the basket for introduction through the hemostasis valve of a 12F or larger vascular sheath.
Compatible Devices:
- Commercially available sheaths 12Fr+, other graspers ≤7Fr
- Snares and other graspers ≤7Fr and > 100cm
| Basket Diameter | Usable Length | Overall Length |
| 10mm (constrained) | 94cm | 98cm |
| 20mm (constrained) | 92cm | 96cm |
| 30mm (constrained) | 86cm | 90cm |
Note that as the basket is constrained, the catheter lengths become longer.
Basket
35mm Nitinol, vessels ≥10mm
Outer Sheath
12Fr min, 75cm max
Inner Lumen
7Fr max, 100cm min
Visualization
Fluoroscopy & ultrasound
Blood Flow
No obstruction when deployed
Access
Uses existing vascular site
ŌNŌ FUNCTIONAL MECHANISMS
- Envelop – ŌNŌ receives the foreign object and then uniquely protects native structures during retrieval (especially important for SS implants or balloon fragment extractions that cannot be compressed)
- Align – ŌNŌ aligns the foreign object with the axial lumen of the retrieval sheath as the object enters the basket (especially important for non-compressible objects such as leadless pacemakers or TEER clips)
- Compress – ŌNŌ compresses Nitinol implants and other objects to allow for percutaneous extraction – longitudinal pull force outside the body is translated into radial compression of foreign bodies inside the vasculature (especially important for septal or LAA occlusion devices)
- Remove – The ŌNŌ removes devices and tissue masses alike percutaneously increasing the likelihood of avoiding highly invasive surgical options
intended use
The 12F ŌNŌ retrieval device is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including, but not limited to, guidewires, coils, balloons, catheters and filters.
how supplied
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened and undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
Basket
10mm
20mm
Unconstrained
Outer Sheath
98cm
96cm
90cm
Inner Lumen
94cm
92cm
86cm
Identification of Symbols Used on Product Labeling
ISO 13485 CERTIFICATE
MDSAP CERTIFICATE