Cook Medical has partnered with IU Health to evaluate a potential treatment for peripheral arterial disease (PAD), a vascular disease of the legs. The treatment involves the placement of a stent, which is a small, metal mesh tube that is inserted into the artery to treat blockages of blood flow.
The study, known as FORMAT, was recently authorized by the U.S. Food and Drug Administration (FDA). The study will include 80 participants from up to 20 treatment centers in the United States, and will investigate the safety and effectiveness of the stent.
One of the study’s co-investigators, Dr. Andrew Ferguson, a cardiologist on the medical staff at IU Health Bloomington Hospital, said, “Typically, patients with PAD present with stable symptoms of pain including hip, buttock, thigh or calf discomfort while walking or at rest. Patients may also develop more severe symptoms of rest pain called critical limb ischemia. Although the disease impacts men and women, some men may also experience erectile dysfunction as a result of PAD. We are very fortunate to be able to collaborate with Cook Medical on such an important study.” Cook Medical manufactures the stent locally. Patients who participate in the FORMAT study with IU Health Bloomington and Dr. Ferguson will have a unique opportunity to be treated with a local manufacturer’s device in a local health care facility while contributing to an important clinical study.
In addition to IU Health Bloomington, the partnership between Cook Medical and IU Health includes IU Health Methodist Hospital in Indianapolis, IU Health Saxony in Fishers, and IU Health Ball Memorial in Muncie. Michael Dalsing, MD, of IU Health Methodist Hospital is the lead investigator for all campuses.
Rob Lyles, the vice president of Cook Medical’s Peripheral Intervention division, said, “We look forward to the opportunity to partner with IU Health on both local and statewide levels. Having worked with hospitals around the world, Cook Medical is excited to work with a hospital system of the caliber of IU Health right here in our own state. We anticipate a wonderful partnership that will benefit fellow Hoosiers.”