Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD), announces its Ocelot System has been cleared for sale in the U.S. by the Food and Drug Administration (FDA).
"It has taken my entire career to get to this moment," said John B. Simpson PhD, MD, Avinger Founder and CEO. "Incorporating intravascular OCT into therapeutic devices has been the biggest priority here at Avinger. We have amazing investors who have allowed us to demonstrate how revolutionary Avinger can be. I'm so proud of our employees, all the physicians and hospitals around the world that helped us bring this amazing technology to the patients in the US."
PAD is an unrecognized epidemic that affects between eight and 12 million adults in the U.S. and 30 million people globally. It is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. "Often times, bypass surgeries or amputations are the recommended solutions. Ocelot can help save patients from such dire circumstances and patients can be back on their feet in days," continued Dr. Simpson.
Patients walk out of the unknown
A total of 122 patients from both Europe and the U.S. took part in the Ocelot global clinical trial, the results of which led to today's FDA clearance. Available here are several stories, told by the Ocelot patients, their family members, friends, work colleagues, and the doctors and nurses who helped them. Here's a snapshot:
Meet John Brindley, Jackson, Mississippi. John is a 66-year old musical choir director in a small town near Jackson. His mysterious leg pain was becoming unbearable, to the point where it was almost impossible for him to walk. Dr. Gray Bennett of St. Dominic Hospital informed him about Ocelot and got him involved in the trial. Now, he's back to work, exercising and feeling motivated to improve his diet.
Meet Jerome Doczekalski, Niles, Illinois. Jerome is a 63-year old passionate golfer. Four years ago, he had a toe infection that simply wouldn't heal. The pain grew worse to the point of being excruciating. He could hardly walk. He couldn't figure out what was going on until he visited Dr. Jack Chamberlin at Alexian Brothers Health System in Chicago. Thanks to Ocelot, Jerome was back on the golf course within just a few days.
Meet Manfred Selenschick, Muenster, Germany. 56 years old, Manfred has been dealing with PAD for years. He had several surgeries that just weren't working. He still could hardly walk and the pain was unbearable in his legs. For the first time in ten years, since Dr. Arne Schwindt of St. Franziskus Hospital used Ocelot to unblock his artery, he's out of pain and walking again. His family is very happy.