Dr. Joseph Lombardi

Study investigators reported positive steps in Cook Medical’s efforts to gain FDA approval of the treatment assessed in the STABLE clinical trial, designed to evaluate the safety and efficacy of a proximal endograft and a distal uncovered stent for the endovascular treatment of Type B aortic dissection for purposes of seeking FDA approval. The findings were presented by Dr. Joseph Lombardi at the 37th annual VEITHsymposium. The trial is the first and only one of its kind to focus on a device uniquely designed for the endovascular treatment of Type B aortic dissection. The system as a whole is an investigational device not available in the United States.

“Open surgery to repair dissection can take a devastating toll on a patient, and we hope the STABLE trial final results support an endovascular solution.”

“The initial data for the STABLE clinical trial show promise,” said Joseph Lombardi, M.D., the study’s principal investigator and chief of vascular and endovascular surgery at Cooper University Hospital and associate professor of surgery at the Robert Wood Johnson Medical School, University of Medicine & Dentistry of New Jersey. “Aortic dissection can be a life-threatening condition, and surgical intervention is a highly invasive procedure. If confirmed, these initial results are a positive step toward proving the safety and efficacy of a minimally invasive treatment for aortic dissection.”

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Cooper University Hospital will take part in a clinical trial of the first medical device designed to specifically treat aortic dissections, an often-fatal condition that affects tens of thousands in the U.S. and claimed the life of actor John Ritter.

Recognized as a preferred treatment center for the minimally invasive treatment of aortic diseases, Cooper was approved by the hospital’s institutional review board (IRB) for its involvement in the study. This approval follows the recent appointment of the trial’s global principal investigator, Joseph V. Lombardi, M.D., FACS, as chief of vascular and endovascular surgery at Cooper and associate professor of surgery at the Robert Wood Johnson Medical School, University of Medicine & Dentistry of New Jersey.

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(Camden, New Jersey) Joseph V. Lombardi, M.D., joins the Department of Surgery at Cooper as the new Head of Vascular Surgery. He is a prominent vascular surgeon with expertise in minimally invasive endovascular therapy. Dr. Lombardi, is pioneering the treatment of thoracic aortic dissection with endovascular grafts and stents. He serves as Global Principal Investigator for the STABLE trial, investigating the use of endovascular therapy to treat complicated Type B Thoracic Aortic Dissection.

“We are developing a masterful team of experts in surgery and Dr. Lombardi brings a talent unseen in our region,” said Jeffrey Carpenter, M.D., Chief of the Department of Surgery at Cooper.

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