News | May 21, 2010

Second OCT System Ready for U.S. Regulatory Study

May 21, 2010 – A second company is hoping to gain U.S. Food and Drug Administration (FDA) clearance for an optical coherence tomography (OCT) intravascular imaging system. Volcano Corp. said its second generation OCT system is pending FDA investigational device exemption (IDE) approval so it can start its VOILA clinical trial in the United States and South America.

Volcano received European CE mark clearance for its OCT system in January and plans the commercial release of the system in early 2011. The company hopes to release the system in the U.S. by mid-2011.
Lightlab received FDA clearance in early May for the first OCT intravascular imaging system approved in the United States. St. Jude Medical announced plans earlier this week it acquire Lightlab.

"St. Jude Medical's acquisition of LightLab confirms the validity and potential utility of this leading edge technology," said Scott Huennekens, president and CEO of Volcano. "We are planning a best-in-class OCT solution. We currently have CE mark in Europe on our first generation platform, and we are targeting a release of our second-generation platform in Europe early next year. We anticipate that this system will incorporate a smaller catheter, shorter prep time, faster pullback speed, and a longer imaging segment than the current device."

OCT provides high-resolution images of the vessel lumen and structural detail not seen with intravascular ultrasound (IVUS) or by angiography. With OCT, physicians can visualize structures in the lumen and the adjacent vessel wall down to a resolution of about 15 microns

"The Volcano OCT system provides fantastic images and is easy to use,” said Dr, Alex Abizaid from the Dante Pazzanese Cardiology Institute in Sao Paulo, Brazil With these OCT images, I can assess thrombus, lesion cap thickness, tissue growth on previously deployed stents and stent apposition at the time of implant. This is another great tool in addition to IVUS and FFR to help me augment angiography."

Volcano's integrated OCT platform will be built around the High-Definition Swept Source (HDSS), a nonlaser light source from Axsun Technologies, a wholly owned Volcano subsidiary. The HDSS has been tested at high speeds, which will translate into fast imaging and significantly faster pullbacks for the physician.

The new system is expected to be able to scan a lesion or stent length in as little as one second.
For more information: www.volcanocorp.com

Related Content

Hielscher, Columbia, PAD, OCT, diabetes, optical tomographic imaging, peripheral

A comparison between a cross section of a foot in a healthy and a diabetic patient with peripheral artery disease. The optical tomographic imaging technology shows blood perfusion, or the absence of perfusion, in the issue.

Feature | February 26, 2015
Approximately 8 to 12 million people in the United States alone are suffering from peripheral arterial disease (PAD), a...
News | January 04, 2011
January 4, 2010 – The U.S. Food and Drug Administration (FDA) has released an update of what medical devices it expects...

The St. Jude Medical Lightlab C7-XR optical coherence tomography imaging system offers better image resolution than current IVUS systems. Pictured is a follow-up study of a stent showing it neointimal tissue strut coverage.

Feature | December 13, 2010 | Dave Fornell
There have only been incremental improvements in intravascular ultrasound (IVUS) over the past decade. However, three...

The St. Jude Medical Lightlab C7-XR optical coherence tomography imaging system offers better image resolution than current IVUS systems. Pictured is a follow-up study of a stent showing it neointimal tissue strut coverage.

Feature | December 13, 2010 | Adrienne Ma, analyst, Millennium Research Group
During a time when the U.S. healthcare reform is on the minds of many within the medical community, physicians and...

Boston Scientific's Atlantis IVUS

News | September 15, 2010
September 15, 2010 – A high-definition intravascular ultrasound (IVUS) system will be demonstrated during the...
News | May 19, 2010
May 20, 2010 – St. Jude Medical Inc. announced yesterday it is purchasing LightLab Imaging Inc. for $90 million....

An optical coherence tomography (OCT) image of a stent in a coronary vessel. The shadows are from the stent struts.

Technology | May 05, 2010
May 5, 2010 – A new high-definition intravascular imaging system gained U.S. Food and Drug Administration (FDA)...

Image created through optical coherence tomography (OCT) of the coronary arteries.

News | March 29, 2010
March 29, 2010 - Optical coherence tomography (OCT) not only has the potential to identify vulnerable plaques, but in...
News | November 06, 2009
November 6, 2009 – Nearly 4 million people nationwide suffer from cardiac arrhythmias each year, according to the 2006...

An example of an intravascular OCT image using the LightLab system.

News | May 21, 2009
May 21, 2009 - LightLab Imaging Inc. this week is launching its next generation optical coherence tomography (OCT)...
Overlay Init