In what we believe is probably a first for medlatest we’ve found a product that received FDA approval before it got its CE mark. Two years after receiving 510(k) approval Vascular Designs, Inc., a medical device manufacturing company, today announced that its IsoFlow™ Infusion Catheter has received CE Mark approval for use in Europe and Canada . The IsoFlow™ Infusion Catheter enables targeted sideways perfusion, allowing physicians to precisely target and isolate areas within the body where the infused drugs are delivered. With IsoFlow™ Infusion Catheter’s unique design, medications can be delivered into areas that could not previously be treated directly, for instance, a cancerous tumor. The device also facilitates the LACE™ (Lateral Arterial Chemo Embolization) procedure.
“CE Mark approval is an important confirmation of the substantial benefits that patients will receive from targeted treatment of cancerous tumors,” said Robert Goldman , CEO of Vascular Designs, Inc. and creator of the IsoFlow Infusion Catheter. “Directing treatment to specific locations increases the number of treatment options allowing better access to tumors and may reduce the discomfort to patients associated with the systemic application of chemotherapy.”
Vascular Designs, Inc. is a medical device company located in San Jose, California . Founder Robert Goldman developed the idea behind Vascular Designs and its innovative IsoFlow™ Infusion Catheter. His personal experience of watching loved ones suffer from, and succumb to cancer, had a profound influence on the creation of IsoFlow.
With the IsoFlow Infusion Catheter’s unique design, medications can be pushed into areas that could not previously be treated directly. According to numerous studies, this type of approach to delivery can increase drug concentrations at targeted sites while reducing systemic exposure, potentially improving treatment outcomes.
The IsoFlow Infusion Catheter gained 510(k) approval in September 2009 and is already in use in hospitals throughout the United States .
Source: medlatest staff, Vascular Designs