Delivering drugs evenly across the vessel and to the vessel wall allows for direct, highly controllable, and concentrated treatment, minimizing the toxicity of systemic administration, while avoiding the “washing away” of drug into the bloodstream. This can reduce drug side effects, increase therapeutic effectiveness, potentially decrease the cost of medical treatment, and improve patient quality of life.

However, the currently marketed devices compromise in one or more performance areas, no one device fully incorporates all desirable features; none can perform therapeutic action and be both effective and atraumatic.

In an attempt to maximize mixing and therapeutic treatment, current pharmaco-mechanical-type systems have high rotational mass and produce uncontrolled, high radial force. Some do not distribute drug coverage evenly or provide controlled infusion from the bulk to the vessel wall to which the agent is being delivered without traumatic contact to the tissue wall. Some other catheters are constructed with only side holes or balloons, which are non-mixing members and do not evenly distribute the agent. In some cases the fluid that is infused is diluted in the flow stream and does not reduce adhesion of the ablation to an intima of the vessel wall.

Traditional elastomeric balloon infusion catheters create high shear stress and excessive pressure on the vessel walls, which can cause damage to the flow surface or in some cases even rupture the vessel. Historically, irrigating balloon catheters have been reported to cause significant damage to the intimal layer of the vessel by fluid jetting and high pressure in localized areas, causing significant injury, including perforation. Some create a high-pressure fluid layer at the catheter tip and cause excessive stress and uncontrollable mechanical dispersion.

In the treatment of patients with kidney failure there is the chance of rupture when current devices are used in and around an AV graft or in delivering medication for irrigating medication in and around peripheral grafts and placed stents.

Current catheters are usually of large profile and do not work well within small-caliber vessels. They cause patient discomfort and do not promote rapid healing. Some systems require large capital equipment outlay by the physician, clinic, or hospital with continuing software and mechanical maintenance costs.

There is a need for a small-caliber infusion catheter that can provide the required therapeutic action, resulting in a more complete reperfusion result with reduced trauma in a more cost effective manner.

Summary of the benefits of the ClariVein™ infusion catheter:

• Usable for a multiple of physician selected procedures with a physician selected drug
• Controls radial and longitudinal drug delivery 
• Delivers small quantities of well-dispersed medication for more even distribution in the treatment site.
• Delivers therapeutic agents within vessels to reduce systemic effects
• Enables the physician to control the catheter
• No catheter exchanges necessary; guidewire is unnecessary
• No physician, clinic, or hospital capital equipment costs required
• Small caliber catheter outer diameter 0.035” (< 3 French)
• Compatible with a Short Peripheral Catheter, 18G or larger, or 4-6 Fr introducer sheath. 
• The unit is a single use, disposable device.
• Can reduce the cost of vascular access.