Acuson of Mountain View, CA, has announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market the AcuNav diagnostic ultrasound catheter. The new tool brings the full performance of diagnostic ultrasound into the heart and may aid in the diagnosis and management of treatment heart disease and irregular heart rhythms, according to the company's press release.
The new intracardiac ultrasound technique works by inserting a catheter through the femoral vein of the leg or the jugular vein in the neck, then maneuvering it into the right atrium or right ventricle of the heart. The catheter's ability to image cardiac structures within the heart also shows potential to expand the utility of ultrasound into areas of electrophysiology, where ultrasound has previously played a limited role.
"This device enables us to clearly see areas of anatomy that govern heart function we have not been able to visualize previously," said James Seward, M.D., a Mayo Clinic cardiologist, director of Mayo Clinic's Echocardiography Laboratory in Rochester, Minn., and one of the inventors of the device. "This catheter with the eyes of ultrasound allows for more precise imaging within the heart and blood vessels."
Initial results of clinical trials indicate that cardiac structures are seen with diagnostic quality 100 percent of the time, according to the company. Prior to clearance, the AcuNav catheter was used for two emergency, life-saving procedures.
In the two isolated cases, physicians used the AcuNav catheter to help guide patient treatment when they were unable to properly visualize cardiac anatomy using available imaging technologies. One case at the University of Michigan Medical Center involved a patient suffering from end-stage primary pulmonary hypertension. The second case involved a patient with pulmonary vein stenosis.
Acuson has a license agreement with Mayo Clinic for use of the new tool. The Mayo Clinic and Acuson each hold a series of patents on, or relating to, the new technology, which was originally conceived by two Mayo Clinic cardiologists, Dr. Seward and A. Jamil Tajik, M.D., chair of Mayo Clinic's Division of Cardiovascular Diseases. A separate team led by Douglas Packer, M.D., a Mayo Clinic electrophysiologist, tested the tool's effectiveness in imaging cardiac anatomy and physiology, and other devices in the heart.
The company anticipates that shipments of the new catheter will begin in the first quarter of 2000.
By AuntMinnie.com staff writersDecember 21, 1999
Copyright © 1999 AuntMinnie.com
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
