Avinger ontvangt CE-goedkeuring voor Ocelot katheter

0
165

Avinger ontvangt CE-goedkeuring voor Ocelot katheter
Avinger, Inc. maakt bekend dat het CE-goedkeuring heeft gekregen voor Ocelot, een systeem dat de in eigen huis ontwikkelde perifere katheterontwerpen van Avinger in combinatie met ingebouwde realtime Optische Coherentie Tomografie (OCT) gebruikt voor de behandeling van perifeer arterieel vaatlijden (PAD).

Ocelot is een grensverleggend nieuw instrument dat toegang biedt tot discrete delen van het perifere vaatstelsel en tegelijk voorziet in OCT-beeldvorming voor navigatie door bloedvaten. Met de Lightbox console van de Ocelot als aanvulling op fluoroscopie heeft de medische specialist voor het eerst de beschikking over een instrument met ingebouwde realtime intravasculaire geleiding. CEO John B. Simpson van Avinger zal beginnen met de commerciele toepassing van Ocelot voor de behandeling van patienten met perifeer arterieel vaatlijden in Europa.
Engelstalig bericht:

Avinger Receives CE Mark Approval for Its Ocelot Catheter That Incorporates Real-Time Intravascular Guidance Using Optical Coherence Tomography (OCT)
CEO John B. Simpson, PhD, MD, will begin commercial use of Ocelot to treat patients in Europe for Peripheral Artery Disease

REDWOOD CITY, Calif.–(BUSINESS WIRE)– 20110926 —

Avinger, Inc. announced today that it has received CE Mark approval for Ocelot – a system that combines the use of Avinger’s proprietary peripheral catheter designs incorporated with real-time Optical Coherence Tomography (OCT) for the treatment of Peripheral Artery Disease (PAD).

Ocelot is a groundbreaking new tool for accessing discrete regions of the peripheral vasculature while simultaneously providing OCT visualization for navigation through arteries. Using Ocelot’s Lightbox console as an adjunct to fluoroscopy, for the first time ever, medical professionals will have access to a therapeutic device that incorporates real time intravascular guidance.

“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,” said founder and Chief Executive Officer John B. Simpson PhD, MD. “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.”

Avinger recently returned from Paraguay where it is currently enrolling patients in the VISTA study. VISTA is a single-center, non-randomized registry study designed to evaluate the safety and efficacy of Ocelot in patients with Peripheral Artery Disease (PAD). The Principal Investigator of this trial is Dr. Adrian Ebner of Sanitorio Italiano in Asunción, Paraguay. Dr. John Simpson of Sequoia Hospital in Redwood City, CA and Dr. John Pigott of Jobst Vascular Institute in Toledo, OH also participated in this ground-breaking first in man registry in Paraguay.

Commercialization of Ocelot in select European countries will begin on September 23, 2011. The first three commercial cases are scheduled to be performed in Italy and Germany in late September and early October. This marks a major step for Avinger in their commitment to providing patients with minimally invasive treatment of vascular disease, an often overlooked epidemic.