Vascular Designs’ IsoFlow™ infusion catheter has secured FDA 510(k) marketing clearance for use as a Class II medical device.
IsoFlow is a dual balloon catheter designed for controlled and selective infusion of physician-specified fluids into selected vasculature by means of temporary occlusion of a target region of the vessel with simultaneous perfusion of blood past the isolated region. With this type of directed approach to fluid delivery, you can increase drug concentrations at targeted sites while reducing systemic exposure, thereby improving efficacy and patient outcomes. This makes IsoFlow ideal for battling diseases such as cancer for which treatment requires the direct infusion of chemotherapy drugs to a targeted region of the body like
The IsoFlow catheter enables sideways perfusion, which
gives you the ability to push specified fluids both into side branch and angiogenicly formed vessels, letting medications reach an isolated area in a highly targeted and concentrated fashion. With IsoFlow’s unique design, fluids can reach areas that could not previously be treated directly.
IsoFlow is inserted with a guide wire and catheter for precise positioning within a patient’s body. Once in place, both of IsoFlow’s balloons are simultaneously inflated using radiopaque fluid via a single inflation lumen. Physician-specified fluid is introduced through the infusion lumen or the guide wire lumen via the one-way stopcock connection. The mixture of infusion and radiopaque agents is then delivered to the target region between the two balloons. For sideways infusion, the guide wire is retracted to allow blood to bypass the isolated target region via holes in the catheter exterior. Complete removal of the guide wire allows fluid delivery from the distal tip. For animation detailing this process, please click here.
The possible applications of IsoFlow are limitless. One potential use is for the treatment of solid cancerous tumors with a defined vasculature. IsoFlow can provide an additional treatment option for patients who are not surgical candidates or who have already exhausted the treatment possibilities of RF ablation, chemoembolization, radiation and systemic chemotherapy. It is not intended for use in coronary vessels.
For more information about IsoFlow or to explore the possibility of applying IsoFlow in your practice, please