Technology | February 11, 2013

New Competitor Enters IVUS Market

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.

For more information: www.svmii.com

Related Content

SpectraWave is developing a a new intravascular imaging system that combines two currently available modalities. This likely includes optical coherence tomography (OCT), left, which can define structures within the vessel and vessel wall.  Near infrared spectroscopy (NIRS), right, enables a spectral chemical analysis of the vessel walls to show areas of high lipid content, and specifically can identify lipid-core plaques that are associated with heart attack-causing plaque ruptures.

News | Cath Lab | February 16, 2021
February 16, 2021 – SpectraWave Inc.
Videos | Cath Lab | February 04, 2021
Cindy Grines, M.D., MSCAI, FACC, president
Among high-risk, chronic, coronary patients who undergo angioplasty, there were no additional benefits from ticagrelor compared to the current standard of care clopidogrel. #AHA #AHA20 #AHA2020
News | Cath Lab | November 16, 2020
November 16, 2020 — The use of the more potent antiplatelet medication ticagrelor (Brilinta) was not superior to clop
A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a DCD was used. #TCT2020 #TCTconnect
Feature | Cath Lab | October 18, 2020
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benef
A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin capped fibrous atheroma (TCFA). #TCTconnect #TCT2020

A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin cap fibro-atheroma (TCFA).

News | Cath Lab | October 18, 2020
October 18, 2020 – Data from the...
The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions. #TCT2-0

The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions.

Feature | Cath Lab | October 16, 2020
October 15, 2020 — Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary ar
Videos | Cath Lab | October 16, 2020
This is an example pf the Shockwave Medical Intravascular Lithotripsy (IVL) catheter system designed to break up heav
Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over