News | January 28, 2014

Infraredx Plans Commercial Manufacturing of TVC Imaging System in Japan

Infraredx Inc. TVC Imaging System Intravascular Coronary Artery Disease
January 28, 2014 — Infraredx Inc.’s TVC Imaging System will be manufactured and distributed in Japan by Nipro Corp. Infraredx intends to commercialize the TVC Imaging System in Japan, China, Korea and other Asia Pacific markets.
 
The companies entered a five-year distribution agreement in 2012 and anticipate regulatory approval from Japan’s Pharmaceuticals and Medical Device Agency (PMDA) in 2014. Infraredx received a $25 million equity investment from Nipro in August 2013, and anticipates a minimum of $50 million in revenues during the duration of the agreement.
 
The TVC Imaging System console will be the first of nine products scheduled for commercial manufacturing at the new facility in Yamanashi Prefecture. Production is scheduled to begin in 2015. 
 
Intravascular ultrasound (IVUS), one of the imaging technologies used by the multimodal TVC Imaging System, is the standard of care in Japan and is used to guide more than 80 percent of percutaneous coronary intervention (PCI) procedures. The TVC Imaging System offers IVUS integrated with near-infrared spectroscopy (NIRS) for lipid core plaque detection. The TVC Imaging System can enable physicians to visualize the presence of plaques, quantify the degree of vessel stenosis (narrowing) and identify lipid core plaques suspected to be prone to rupturing and causing dangerous blockages.
 
The TVC Imaging System is an intravascular imaging system that intends to aid physicians evaluate true vessel characterization for treating coronary artery disease. The TVC Imaging System helps interventional cardiologists identify which patients are prone to complications during stenting and predict the risk of peri-procedural heart attacks by assessing not only the degree of stenosis, but also the presence and extent of lipid core plaques (LCP).
 
The device is approved in both the United State and Europe to detect LCPs. NIRS measurements have been made in over 5,000 patients in over 100 hospitals worldwide.
 
For more information, visit www.infraredx.com.

Related Content

Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter
News | Chronic Total Occlusion (CTO)| June 28, 2017
June 28, 2017 — Royal Philips recently announced the relaunch of its Pioneer Plus...
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
COLOR trial, TCT, NIRS, stenting vulnerable plaques, near infrared spectroscopy

An intravascular ultrasound image (IVUS) with co-registered NIRS showing yellow for the detection of lipid rich plaque in a coronary artery. 

News | Cath Lab| November 07, 2016
November 7, 2016 – Two-year results from the COLOR Trial, the first large-scale multicenter prospective study of its
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...
Overlay Init