St. John Hospital Enrolls PAD Patient in Avinger’s CONNECT II Clinical Trial
St. John Hospital & Medical Center: Detroit
Wednesday, June 06, 2012
Contact: Brian Taylor, 586-753-0726.
Detroit - St. John Hospital and Medical Center announces its participation in CONNECT II, a global clinical trial conditionally approved by the FDA that gives physicians access to a sophisticated new imaging technology tool to fight peripheral arterial disease. The technology, called Ocelot, helps to eliminate the need for bypass surgeries and/or amputations in patients with the disease. Each year, nearly 200,000 amputations occur as a result of PAD and many of them can be avoided.
CONNECT II is a prospective, multi-center, non-randomized global clinical study that will evaluate Ocelot, the first-ever interventional device that allows physicians that treat peripheral artery disease to drill through totally blocked arteries in the legs while using an integrated camera to see from inside the artery.
PAD, affecting between 8 and 12 million adults in the U.S. alone, is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. Because some blockages can become so severe and difficult to penetrate with traditional catheters, patients (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 50 often face amputation, the worst-case scenario associated with PAD.
Doctors at St. John Hospital, as part of CONNECT II, will use Ocelot on enrolled patients to help restore blood flow in completely blocked arteries in patients’ legs through a simple two-millimeter skin incision, helping to avoid amputation.
CONNECT II trial procedures using Ocelot are minimally invasive and designed to allow patients to leave the hospital within hours, and return to normal activities within a few days.
CONNECT II is a prospective, multi-center, non-randomized global clinical study that will evaluate Ocelot on 100 PAD patients.
St. John Hospital and Medical Center is a member of St. John Providence Health and the St. John Providence Health Heart & Vascular Center of Excellence, a leading provider of heart and vascular care in Michigan. SJH&MC is a nationally recognized leader in cardiovascular care. Contact St. John Providence Health at 866-501-3627.