Technology | Atherectomy Devices | December 23, 2016

FDA Clears Vessel Measurement Via Touchscreen Using Avinger’s OCT Imaging Capability

Technology upgrade to Lightbox L250 allows physicians to accurately assess luminal gain from atherectomy

Pantheris, OCT, Avinger, Lightbox L250

December 23, 2016 — The U.S. Food and Drug Administration (FDA) granted a new 510(k) clearance for Avinger’s Lightbox L250 imaging console. It allows detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris Lumivascular atherectomy procedures for the treatment of peripheral artery disease (PAD). The atheterctomy system offers integrated optical coherence tomography (OCT) intravascular imaging.

In addition, this enhanced technology allows the clinician to create borders and measurements in seconds to determine the area of any vessel feature, automatically generate minimum and maximum diameters within a given area, and generate vessel size measurements for reference vessel sizing to facilitate adjunctive therapies. Users can easily add and move reference points for even greater control.

“The ability to obtain an accurate and real-time measurement from inside a diseased vessel is vital – it provides us key pieces of information that we can use to determine the levels of stenosis and luminal gain both during and immediately after an atherectomy procedure,” said Sean Janzer, M.D., interventional cardiologist from Einstein Medical Center in Philadelphia, Pa. “Additionally, the measurements made possible by this latest upgrade will help optimize both the atherectomy and adjunctive therapies performed post-atherectomy, such as the deployment of a drug-coated balloon or placement of a stent.”

“We are excited to announce this latest FDA clearance, which greatly enhances the ability of the Lightbox L250 to accurately provide vessel measurements, further advancing the potential of Lumivascular technology to dramatically improve patient care,” said John B. Simpson, Ph.D., M.D., Avinger’s founder and executive chairman. “Achievement of this FDA clearance is a key step in our ongoing commitment to ensuring our users have the latest technological advancements at their fingertips for greater confidence and control in treating patients with PAD.”

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using OCT, which is displayed on the Lightbox console. In the past, physicians have had to rely solely on X-ray as well as tactile feedback to guide their tools while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

The new software will be made available to all existing L250 users at no cost and will be incorporated in all future Lightbox products as part of the standard software packages.

For more information: www.avinger.com

Related Content

Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Overlay Init