Vascular Designs, a medical device company, today announced that its IsoFlow(TM) infusion catheter has secured 510(k) marketing clearance by the U.S. Food and Drug Administration (FDA) for the direct delivery of medications into highly targeted areas. An important application of IsoFlow may be in the treatment of cancer.
The IsoFlow Infusion catheter enables sideways perfusion, which allows physicians to precisely target and isolate areas within the body where the infused drugs are delivered. With IsoFlow's unique design, medications can be delivered into areas that could not previously be treated directly, for instance, a cancerous tumor. According to numerous studies, this approach lets physicians increase drug concentrations at targeted sites while reducing systemic exposure, thereby improving efficacy and patient outcomes when treating illnesses such as cancer with chemotherapy.*
"In select clinical situations, the benefits of delivering a local endovascular drug dose without systemic exposure can reduce complications, improve results, and benefit patients," said Dr. Michael Dake, former chief of interventional radiology and current professor of cardiothoracic surgery at Stanford University School of Medicine. "The IsoFlow catheter facilitates the use of regional infusion therapies, especially in cases of challenging arterial anatomy where it helps achieve these promises of targeted delivery. IsoFlow is a valuable addition to our treatment arsenal."