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FAQ’s

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Finesse BTK Multicath – Frequently Asked Questions (FAQ)

General Information

The Finesse BTK Multicath is a multi-purpose catheter designed for below-the-knee (BTK) revascularization. Finesse is trimodal–it functions as a crossing catheter, diagnostic catheter, and angioplasty balloon catheter in one device. Combining these functions into a single device is expected to reduce the need for multiple catheter exchanges during complex revascularization procedures.

Unlike traditional monofunctional angioplasty balloon catheters, the Finesse BTK Multicath allows on-the-fly contrast arteriography and injection of fluids through side exit holes proximal to the balloon, even with the guidewire in place. It is the only 0.014″ small vessel platform on the market, and was designed to simplify BTK revascularization procedures.

The Finesse BTK Multicath is intended for angioplasty in patients with critical limb ischemia (CLI) due to calf or foot arterial insufficiency, and was designed with patients at risk of limb amputation in mind, including those with diabetes mellitus (DM) and chronic kidney disease (CKD).

BTK procedures involve diagnostic autography, crossing the lesion, angioplasty, and other interventions done to achieve lumen gain, e.g., atherectomy, stent placement. 
 
The paradigm shift is that the Multicath has an expanded role compared to monofunctional balloon catheters, and can be used to obtain distal angiographic images, cross the lesion, dilate, inject vasodilators if needed, and perform completion angiography. It can be used as a workhorse to complete much of a revascularization procedure, starting during the later stages of a diagnostic arteriogram to complete the below knee arteriogram and proceed directly to lesion crossing.
 
Used that way, extra long sheaths (e.g., >25cm) and microcatheters are not necessary, potentially lowering overall equipment costs when compared to procedures that involve extra long sheaths, microcatheters, and conventional angioplasty balloon catheters. 
 
Moreover, that may save time and make procedures easier to perform. That can be eye opening. To quote an unsolicited comment from one of our early users, “Used a Multicath today…Completely occluded AT, crossed no problem, excellent result and the final image was a 2cc injection of 50/50 contrast through the balloon. Very impressive!!”

Technical Specifications

  • Over-the-wire (OTW)
  • 0.014” guidewire compatible
  • Pushability of a 4.7 Fr proximal shaft
  • High-performance angioplasty balloon on a 3 Fr distal shaft
  • Balloon diameters: 2, 2.5, 3, 3.5, 4 mm
  • Balloon lengths: 20, 40, 60, 100, 225 mm
  • Catheter working lengths: 150, 100, 65 cm
  • Semi-compliant balloon for better flexibility
  • Hydrophilic coating for smooth navigation
  • Rated burst pressure: 12 atm
  • Low tip entry profile: 0.016”

The semi-compliant balloon allows for variable diameter at different pressures within a range of approximately +/-10% (see compliance table on IFU and product label). It can be used first distally at lower pressures and then proximally at higher pressures, achieving slightly different dilation diameters with the same balloon.

Clinical Applications & Usage

Finesse was designed for BTK procedures for patients with CLI at risk of amputation.

Using Finesse as the initial catheter to begin a revascularization procedure after diagnostic angiography may help reduce catheter exchanges and procedure time. The ability to inject contrast locally can be an aid in lesion crossing. Finesse has a tip entry profile comparable to a microcatheter, a hydrophilic coating, and the pushability of a 4.7 Fr proximal shaft. Finesse also carries a balloon, which can be an advantage to provide balloon-assisted lesion traversal–when inflated the balloon can stabilize the tip of the catheter and make it resistant to kick back during guidewire advancement. Similarly, if the guidewire gets stuck the balloon can be inflated which can stretch the vessel and allow the guidewire to advance further. The balloon can then be deflated and continue to be used in crossing the lesion. 

The injectability feature allows for contrast arteriography without requiring a separate diagnostic catheter, reducing the need for some other equipment. It also can be used to cross lesions, potentially avoiding the need for a microcatheter.

Because the injection exit ports are in close proximity to where the images are typically acquired, diagnostic quality angiographic images can be obtained with ultra-low doses of contrast, as little as 0.5 to 1 ml of 300mg/ml iodinated contrast per acquisition.

Catheter exchanges typically use fluoroscopy to monitor progress, such as guide wire position. Therefore, reducing catheter exchanges is expected to reduce radiation.

Also, since contrast is injected typically in close proximity to the area being imaged, there is minimal delay between contrast injection and the appearance of contrast on the image. Because of that, the number of images without contrast early in an acquisition can be reduced or eliminated. The radiation for each of those wasted images early in an acquisition can be avoided.

Conventional catheters are monofunctional–they are designed to perform a single function. Trimodal catheters perform three functions: injection, balloon-assisted crossing, and angioplasty. First, injectability over the guidewire at anytime enables fluid injection or aspiration and also permits pressure measurements to be done. Second, Finesse has a low-profile balloon with excellent rewrap and can be used for balloon-assisted crossing, a valuable technique. Third, Finesse has high-performance low-profile angioplasty balloons that can achieve definitive revascularization results in many patients.

Operational Guidelines

  1. Tighten the Tuohy-borst valve on to the guidewire by turning the wheel clockwise until finger-tight.
  2. Connect a 5 or 10 ml syringe to the most proximal side port.
  3. Inject half strength contrast through the Luer Activated Valve (LAV) on the side of the Tuohy-borst adapter.
  4. Observe contrast exiting the catheter immediately proximal to the balloon.

No, an operator does not necessarily have to adjust the Tuohy-borst valve every time they reposition the catheter or guidewire. It is often possible to “set and go”, i.e., find a setting where the valve can be fluid tight but not so tight that it prevents slideable motion relative to a guidewire.

No, the Finesse BTK Multicath should not be used with a power injector. Manual injection is required.

  • 25% contrast for the balloon, 300mg/ml iodinated contrast
  • 50% contrast for injection, 300mg/ml iodinated contrast

Yes, contrast or medication can be injected with the guidewire in place, anytime, on the fly during a procedure.

Yes. If the guidewire is retracted proximal to the balloon so that it isn’t within the balloon, contrast will exit the distal endhole as well as the side exit holes. It is not necessary to completely remove the guidewire.

Competitive Advantage & Value Proposition

The Finesse BTK Multicath is the only 0.014” compatible multifunctional revascularization catheter on the market in the U.S.  It can replace diagnostic catheters, crossing catheters, guide wire support catheters, microcatheters, and conventional monofunctional angioplasty balloon catheters. 

Early customer feedback indicated that Finesse BTK Multicath can:

  • Reduce procedure time
  • Reduce equipment costs
  • Lower contrast usage, which may be beneficial for CKD and diabetic patients

Since exchanges are a frequent cause of lost guidewire access, it makes sense that fewer exchanges would reduce the risk of losing guidewire access.

Sterilization

Finesse BTK Multicath is sterilized using electron beam technology, which is more environmentally and patient friendly than the conventional method, ethylene oxide gas (EtO), a known carcinogen.

More Information

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