LOVE YOUR LIMBS™

The case for an endovascular approach to treatment.

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

It is estimated that there are between 8 and 10 million people in the U.S. with Peripheral Arterial Disease (PAD) and that there are 220,000 – 240,000 amputations each year in the United States and Europe due to PAD.1,2 Endovascular treatment offers patients and physicians a minimally-invasive alternative to surgical options.3 Bard Peripheral Vascular offers treatment tools that can be used in PAD and CLI cases to help reduce the risk of amputation.

VASCUTRAK® PTA Dilatation Catheter and CROSSER® CTO Recanalization Catheter Successfully Relieves CTO of the Anterior Tibial Artery

CLINICAL EXPERIENCE:
Neil E. Strickman, MD and Federico E. Azupurua-Gil, MD
Texas Heart Institute / St. Luke’s Hospital
Houston, Texas

Patient Overview
A 47-year-old male was admitted to the hospital with left leg critical limb ischemia (CLI), osteomyelitis and a non-healing ulcer of the left foot.

Procedural Highlights
An angiogram revealed the posterior tibial was 100% occluded proximally, the peroneal artery was diffusely diseased while the anterior tibial (AT) had a short 4cm chronic total occlusion (CTO). It appeared the only way to save the leg and foot was to open the CTO of the AT allowing more blood to flow distally to the foot. A CROSSER® CTO Catheter traversed the CTO of the AT and a VASCUTRAK® PTA Catheter was advanced and inflated at the site of the occlusion.

Discussion
Post interventional intravascular ultrasound (IVUS) and angiographic results showed no significant residual stenosis or dissection. The use of the CROSSER® Catheter and VASCUTRAK® Catheter in this location provided an alternate approach to stenting a CTO.


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. N.E. Strickman is currently a consultant for Bard Peripheral Vascular, Inc.

Total occlusion of AT.
AT post-recanalization with a CROSSER® Catheter and post-dilation with a VASCUTRAK® Catheter.
IVUS post-recanalization with a CROSSER® Catheter.
IVUS post-dilatation with a VASCUTRAK® Catheter.

Safety information

Indication for Use: The CROSSER® Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The CROSSER® Catheter is only intended for use with the CROSSER® Generator. Refer to the CROSSER® Generator Manual of Operations for proper use.

Contraindications: The device is contraindicated for use in carotid arteries.

Adverse Effects: As with most percutaneous interventions, potential adverse effects include: Bleeding which may require transfusion or surgical intervention, Hematoma, Perforation, Dissection, Guidewire entrapment and/or fracture, Hypertension / Hypotension, Infection or fever, Allergic reaction, Pseudoaneurysm or fistula Aneurysm, Acute reclosure, Thrombosis, Ischemic events, Distal embolization, Excessive contrast load resulting in renal insufficiency or failure, Excessive exposure to radiation, Stroke/CVA, Restenosis, Repeat catheterization / angioplasty, Peripheral artery bypass, Amputation, Death or other bleeding complications at access site.

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

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

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.

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.

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