St. Dominic is among first few hospitals worldwide selected to participate in limb-saving global clinical tria
Ocelot allows physicians treating Peripheral Artery Disease (PAD) to drill through totally blocked arteries in the legs while using an integrated camera to see from inside the artery.
Earlier this spring, St. Dominic’s was selected as the first hospital in Mississippi and only the second one in the United States to participate in CONNECT II, a global clinical trial conditionally approved by the FDA. It provides physicians access to a sophisticated new imaging technology tool – Ocelot – to fight peripheral arterial disease (PAD).
|Every year, nearly 200,000 amputations occur nationwide as a result of PAD, which affects 8 to 12 million adults. Because some blockages can become so severe and difficult to penetrate with traditional catheters, patients who are unaware of other options often resort to undergo 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,” said interventional cardiologist William Crowder, MD, of the Jackson Heart Clinic, who is partnering with Gray Bennett, MD, and Huey McDaniel, MD, on CONNECT II at St. Dominic Hospital. Days after getting the green light, the trio performed two successful procedures with Ocelot.
“The catheter essentially helps us cross arteries in the leg that are completely blocked,” said Crowder. “It does so in a way that allows us to see on a monitor what we’re actually doing, where the catheter is, and makes it safer for the patients who previously had blockages that were unable to be treated, or if they were treated, required an invasive procedure. Ocelot, being used in the clinical trial, is a very important new innovation.”
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 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.”
Specifically, Ocelot is the first-ever catheter that can access exact regions of the peripheral vasculature where the blockages occur, while simultaneously providing physicians with visualization for real-time navigation during an intervention.
Bennett, an interventional cardiologist for Jackson Heart Clinic, said Ocelot will give better patient outcomes through faster procedure times. McDaniel, a vascular surgeon for the 535-bed St. Dominic Hospital, traveled to Germany to watch 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 the European Union, where Ocelot received CE Mark in 2011.
When implementation of Ocelot is mainstreamed, it should defray $21 billion in hospitalization costs of PAD alone, primarily so costly because of late detection and patients experiencing a decreased quality of life from invasive bypass surgery and/or amputation.
“I’ve personally had patients within the last year 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 for the treatment of blocked vessels.”
CONNECT II uses Ocelot on enrolled patients to help restore blood flow to completely blocked arteries in patients’ legs through a simple 2-millimeter skin incision, helping to avoid amputation. Importantly, CONNECT II trial procedures using Ocelot are minimally invasive and designed to allow patients to leave the hospital within hours, returning to normal activities within a few days.
“Now patients who would’ve otherwise experienced the worst case scenario of amputation may have hope for normal function in their legs,” said Crowder.