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PTA ULTRAVERSE® 014/018 PTA Dilatation Catheter
VASCUTRAK® PTA Dilatation Catheter

Angioplasty Options for PAD and CLI
Angioplasty can be anything but routine when treating a complex CLI case. BARD offers small vessel and specialty balloons designed for the treatment of PAD and CLI. The ULTRAVERSE® 014/018 PTA Dilation Catheter is a small vessel catheter that is designed to deliver across tight lesions. The VASCUTRAK® PTA Dilation Catheter bends the limits of what is possible with a PTA balloon. The VASCUTRAK® Catheter utilizes two longitudinal wires to provide focused force on the lesion allowing it to dilate occluded vessels.

PTA in CLI
Studies have found that PTA is an excellent primary treatment for CLI cases. 3,4,5

Focused Force
The VASCUTRAK® Catheter has two external wires that concentrate force against the lesion fracturing it at low inflation pressures and allowing for more controlled, less damaging inflation compared to standard PTA.


Safety information

ULTRAVERSE® 014/018 PTA Balloon Dilatation Catheter

Indication for Use: ULTRAVERSE® 014 and ULTRAVERSE® 018 PTA Dilatation Catheters are recommended for use in percutaneous transluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. These catheters are not for use in coronary arteries.

VASCUTRAK® PTA Balloon Dilatation Catheter

Indication for Use: The VASCUTRAK® PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arterioveneous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.

Contraindications: The VASCUTRAK® PTA Catheter is contraindicated where there is the inability to cross the target lesion with a guidewire and for use in the coronary or neuro vasculature.

Adverse Events for Percutaneous Transluminal Angioplasty: The complications that may result from a peripheral balloon dilatation procedure include: Additional intervention, Allergic reaction to drugs or contrast medium, Aneurysm or pseudoaneurysm, Arrhythmias, Embolization, Hematoma, Hemorrhage, including bleeding at the puncture site, Hypotension/hypertension, Inflammation, Occlusion, Pain or tenderness, Pneumothorax or hemothorax, Sepsis/infection, Shock, Short term hemodynamic deterioration, Stroke, Thrombosis, Vessel dissection, perforation, rupture, or spasm.

Three primary components that have the potential to reduce the risk of amputation even in advanced stages of Critical Limb Ischemia (CLI).

CASE STUDY CLINICAL EXPERIENCE:
David Allie, MD, Medical Director
Louisiana Cardiovascular and Limb Salvage Center

VASCUTRAK® PTA Dilatation Catheter in Chronic Total Occlusion (CTO) of the Anterior and Posterior Tibial Arteries

Patient Overview
A 70-year-old male presented with ischemic changes to the left lower extremity. Baseline angioplasty revealed total occlusion of all infrapopliteal vessels with the anterior tibial (AT) and posterior tibial (PT) filling via collaterals. With two vessels filling via collaterals, it was felt in this case that a more global approach to revascularization may expedite wound healing.

Procedural Highlights
A CROSSER® Recanalization Catheter 14S was used to traverse the occlusion of the anterior tibial. A VASCUTRAK® PTA Dilatation Catheter was advanced to the occlusion. One inflation was performed at 3 ATM for 3 minutes. Following balloon inflation, excellent angiographic results were noted. The CROSSER® Recanalization Catheter 14S was then used to cross the posterior tibial artery. The VASCUTRAK® PTA Dilatation Catheter was advanced to this occlusion, and two 3 minute inflations at 4atm were performed.

Discussion
This case illustrates the value of focused force in the treatment of multiple long infrapopliteal occlusions. By utilizing longer balloons at lower inflation pressures, areas of long total occlusion can be treated by the same balloon with a reduced risk of balloon-induced over dilatation and subsequent dissection. By not having to perform adjunctive therapies, time and contrast are saved, allowing for treatment of a second vessel if necessary.


The opinions and clinical experiences presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes. The physician has been compensated by Bard Peripheral Vascular for the time and effort in preparing the above case study for Bard’s further use and distribution. D. Allie is currently a consultant for Bard Peripheral Vascular, Inc.

Complete occlusions of the left AT, PT and Peroneal. AT and PT are filling via collaterals.
Post intervention with a 2.5 x 120mm VASCUTRAK™ Catheter. Excellent angiographic results noted.

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