Purpose : To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). Methods : The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire ...
A system for optical coherence tomography includes a source of optical radiation, an optical fiber, and a graded index fiber attached to a distal end of the optical fiber. The optical fiber and the graded index fiber are together configured to provide a common path for optical radiation reflected from a reference interface at a distal end of the graded index fiber and from a target.
Peripheral arterial disease (PAD) is a growing clinical condition affecting more than 10 million patients in the United States and it is responsible for more than 120,000 amputations annually. The presence of chronic total occlusions (CTO) increases the complexity of endovascular procedures and open surgery may often be the preferred approach. Despite the optimization of the CTO devices and technique, percutaneous CTO revascularization remains a challenging procedure even for experienced operators with important complication rates. The Ocelot TM system is a novel CTO device to use real-time optical coherence tomography (OCT) imaging guidance for the recanalization of peripheral CTOs ...
St. Dominic Hospital’s cardiovascular surgeon Huey B. McDaniel, MD became the first in the nation to commercially use the Ocelot Device that helps treat peripheral artery disease. The event happened Nov. 8. St. Dominic’s is the only hospital in Mississippi where the Ocelot device is available. Ocelot, a new, sophisticated imaging technology tool designed to help patients suffering from Peripheral Artery Disease (PAD), was recently cleared for use by the FDA. Physicians at St. Dominic’s are experts in the use of this device, as they were among the first to use this new technology.
Avinger Inc was founded in 2007 by John B. Simpson, Ph.D., M.D., Avinger, Inc. is developing the next generation of catheter-based technologies for the treatment of cardiovascular and peripheral vascular disease, utilizing our core competencies in medical device catheter engineering and intravascular imaging. Avinger acquired Sawtooth Laboratories in 2010.
The CE Mark approval for Wildcat is a huge step for Avinger and our dedication to helping the millions of afflicted PAD patients worldwide...With the rate of PAD in Europe closely rivaling the U.S., more and more patients are confronted with the threat of amputation and quality-of-life issues resulting from invasive bypass surgery. We are thrilled to be one step closer to our goal of empowering physicians everywhere with the most advanced tools and technologies to perform the least invasive procedures for PAD sufferers around the globe.John B. Simpson in Avinger Receives CE Mark Approval for Its Wildcat Catheter for the Treatment of Peripheral Artery Chronic Total Occlusions and Will Present Results from Its Connect Study at EuroPCR Conference May 17-19
Ocelot CE Mark is a long anticipated milestone for Avinger and a much larger milestone for me professionally. I’ve been working on uniting intravascular guidance with therapeutic products for 30 years and I’m humbled that we’ve been able to achieve this at Avinger... This speaks volumes about our team at Avinger and their dedication to patient care. Ocelot CE Mark is a pivotal step that allows us to immediately help more patients suffering from PAD.”John B. Simpson in Avinger Receives CE Mark Approval for Its Ocelot Catheter That Incorporates Real-Time Intravascular Guidance Using Optical Coherence Tomography (OCT)
This is a major milestone for Avinger and a true testament to the perseverance of all our employees and investors. Many people said we couldn't do it...Ocelot and CONNECT II is our first step toward incorporating intravascular imaging into therapeutic catheters. We truly believe this will revolutionize the treatment of vascular disease and amputation prevention.John B. Simpson in Avinger Enrolls First European PAD Patient in CONNECT II Global Clinical Trial