Mississippi medical team makes history performing nation’s first commercial PAD procedure using FDA-cleared Ocelot device
JACKSON, MISS. – In early November, heart specialists at St. Dominic Hospital in Jackson, Miss., became the nation’s inaugural medical team to commercially use the FDA-cleared Ocelot device to successfully facilitate the treatment of peripheral artery disease (PAD) for their patients.
The medical milestone occurred only months after St. Dominic’s was selected as only the second hospital in the United States to participate in CONNECT II, a global clinical trial.
“The difficulty physicians experience when crossing a totally occluded vessel is that even with contrast, you can’t see the vessel due to the blockage,” said interventional cardiologist Gray Bennett, MD. “Now instead of relying on a guide wire, you can see the inside of the vessel and the occlusion clearly.”
The Ocelot catheter allows physicians to see from inside an artery during the procedure, using optical coherence tomography. This advancement is significant because physicians previously relied solely on x-rays and touch-and-feel to guide the catheters through blockages. With the Ocelot system, they’re able to more accurately navigate the catheter.
“The advantage of the Ocelot is that it allows you to see where you are within the occlusion, and if you’re too near to the vessel wall,” said cardiovascular surgeon Huey B. McDaniel, MD. “It adds a tremendous safety factor and improves the odds of successfully crossing the occlusion.”
The minimally invasive procedure, which requires a simple 2-millimeter skin incision, allows patients to leave the hospital within a few hours, and to return to normal activities within a few days.
“This new technology allows patients, who in the past have been forced to live with these severe blockages because the risks of complex open surgery or crossing the occlusion using a minimally invasive procedure were too great, to now possibly be a candidate for a procedure using the Ocelot,” said interventional cardiologist William Crowder, MD, of the Jackson Heart Clinic, who collaborated with Bennett and McDaniel on the groundbreaking procedure. “This new option to help restore their circulation through a minimally invasive route can really better the quality of life for that type of patient.”
Every year, nearly 200,000 amputations occur nationwide as a result of complications from PAD, which affects 8 to 12 million adults. Because some blockages may become so severe and difficult to penetrate with traditional catheters, patients who are unaware of other options often resort to extremely invasive bypass surgeries that result in even higher health risks and lengthy, painful recoveries. Patients over the age of 50 are at a higher risk of amputation, the worst-case scenario associated with PAD.
Many amputations may be avoided with this new technology, Crowder emphasized.
“Now patients who would’ve otherwise experienced the worst case scenario may have hope for normal function in their legs,” he said.
Renowned cardiologist and medical device entrepreneur John B. Simpson, MD, founded Avinger in 2007 to market Ocelot, the market’s first real-time OCT crossing catheter, and other innovative catheter-based technologies.
“Gray, Huey and I had adopted a particular catheter of theirs early on, so Avinger knew we liked their technology and that we handle difficult cases,” said Crowder. “The company also knew that at the Jackson Heart Clinic, where Gray and I are partners, we employ a full-time researcher. We have the facility to carry out a research trial of this magnitude, and it fell into place for us to be an early selected site.”
McDaniel traveled to Germany to observe Ocelot procedures.
“Then we spent a lot of time with Dr. Simpson here on site,” said Crowder. “He’s amazing. If you look at the top five innovators in the field of cardiology and interventional cardiology, his name will be on that list. He’s developed many different devices and balloons throughout his career. He’s an innovator and we’re very thrilled to have a relationship with him. I believe we impressed him enough for us to be the go-to site for any new tools for vascular disease.”
CONNECT II is a prospective, multi-center, non-randomized global clinical study that evaluates Ocelot on 100 PAD patients with femoropopliteal CTO lesions at 17 sites, including three in Europe, where Ocelot received CE Mark in 2011.
When implementation of Ocelot is mainstreamed, it’s anticipated to defray $21 billion in hospitalization costs of PAD alone, a disease that’s primarily costly to treat because of late detection and patients experiencing a decreased quality of life from invasive bypass surgery and/or amputation.
“I’ve personally had patients (before the CONNECT II trial) who required long procedure times, multiple procedures and multiple devices to accomplish what we can accomplish with the Ocelot catheter all in one, shorter procedure,” said Bennett. “This device allows us to concentrate our efforts to cross these chronically occluded vessels and keeps open options the treatment of blocked vessels.”