New Competitor Enters IVUS Market


February 11, 2013
Silicon Valley Medical Instruments Inc.  HD-IVUS FDA Clearance

February 11, 2013 — Silicon Valley Medical Instruments Inc. (SVMI) was granted 510(k) market clearance from the U.S. Food and Drug Administration (FDA) in January for its HD-IVUS ultrasound imaging system.

The HD-IVUS ultrasound imaging system is a minimally invasive intravascular ultrasound diagnostic imaging tool, used in conjunction with an intravascular ultrasound catheter. The system is a medical device for use by or on the order of a physician. The HD-IVUS is comprised of a system console with a touchscreen monitor, roll stand or bed-rail swing arm mount, patient interface module (PIM), power supply, and an intravascular ultrasound catheter [510(k)-cleared and  sold separately].

The catheter emits sound energy from a transducer at the distal tip of the catheter, which is guided into the coronary arteries of the heart. Sound waves that reflect from the inner vascular tissues are received by the transducer and sent to the system console where a high-resolution, cross-sectional image is displayed in real time. The technique provides for in vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall.

The system console receives, processes, displays and records ultrasound image data from the transducer in the Kodama HD-IVUS catheter. The IVUS images are displayed on a high-resolution, 19-inch, flat-panel, touchscreen monitor. The monitor serves as a graphical user interface (GUI) for operating the system. All system information and controls are located on the touchscreen monitor.

The HD-IVUS system also has internal storage for patient studies. Each study can contain data in the form of loops or stills. Study data is saved in digital imaging and communications in medicine (DICOM) format and can be exported to DVID, using the integrated DVD drive, or to a USIB storage device, using one of the four USB ports.

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