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

Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices| February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Avinger, Lightbox L250 imaging console, upgrade, Lumivascular platform, OCT, optical coherence tomography
Technology | Intravascular Imaging| January 11, 2017
January 11, 2017 — Avinger Inc. recently announced the U.S.
Sponsored Content | Videos | TCT| November 18, 2016
DAIC Editor Dave Fornell takes a video tour of some of the most innovative new interventional cardiology technologies
OCT stent strut coverage

OCT imaging showing neointimal tissue coverage of metallic stent struts.

News | Stents| November 07, 2016
November 7, 2016 – Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
OCT, optical coherence tomography, coronary stent implantation, superior resolution, TCT 2016, ILLUMIEN III OPTIMIZE PCI Trial
News | Optical Coherence Tomography (OCT)| October 31, 2016
Optical coherence tomography (OCT) provides safe and improved guidance for patients undergoing percutaneous coronary...
Avinger, Pantheris atherectomy catheter, OCT, Lumivascular technology, expanded FDA indication, diagnostic imaging device
News | Atherectomy Devices| October 20, 2016
Avinger Inc. recently announced that the company has received expanded indications from the U.S. Food and Drug...
Avinger, U.S. Department of Veterans Affairs, VA, Lumivascular technology, FSS Contract Award
News | Optical Coherence Tomography (OCT)| September 27, 2016
Avinger Inc. recently announced the company has received an FSS Contract Award from the U.S. Department of Veterans...
News | Peripheral Artery Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
bioresorbable stent, bioabsorbable stent, Absorb BVS, visualizing bioresorbable stents

A comparison of how the Abbott Absorb BVS appears with intravascular ultrasound (IVUS) on the left, and optical coherence tomography (OCT) of the right. The stent is difficult to visualize and sizing is critical, so both modalities can help in bioresorbable stent measurements and to confirm stent apposition. Left image from the Volcano IVUS system and the right image from St. Jude Medical's OCT system.

Feature | Stents Bioresorbable| July 21, 2016 | Alphonse Ambrosia, D.O.
Some have labeled bioresorbable scaffolds (BRS), also known as bioresorbable stents, as the fourth evolution of inter
Overlay Init