An imaging device includes a hollow flexible shaft having a central longitudinal axis and an imaging window therein. An optical fiber extends within the hollow flexible shaft substantially along the central axis. A distal tip of the optical fiber is attached to the hollow flexible shaft and aligned with the imaging window so as to transfer an optical coherence tomography signal through the imaging window.

The present invention relates to: (1) guidewire support/placement catheters; (2) support/placement catheters with imaging; (3) atherectomy catheters, (4) atherectomy catheters with imaging, (5) occlusion crossing catheters, and (6) occlusion crossing catheters with imaging as well as methods for using them to treat disorders (and particularly peripheral artery disease) and systems including them.

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.