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.
Fourteen patients with 27 affected limbs had previously been diagnosed with PAD via ultrasound and/or angiography in one or both limbs.
Each patient was assessed first with a Doppler Ankle Brachial Index (ABI) and then with the FLOCHEC™ Digital ABI after a light exercise protocol. Measurements with the FLOCHEC™ Digital ABI were made bilaterally at both index fingers and both big toes.
The FLOCHEC™ Digital ABI was comparable to standard ABI in terms of recognizing reductions in arterial flow to the lower extremities. The sensitivity of both the Doppler ABI and FLOCHEC™ System was 78%. FLOCHEC™ Digital ABI may have significant advantages in clinical practice in terms of applicability, reproducibility, and ease of use.
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 center staff received compensation for the time and effort in preparing the above case study for further use and distribution.
Indications for Use: To monitor relative blood flow changes distal to the occlusion of a brachial, radial, ulnar, or femoral artery. From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to an extremity.
Contraindications: The device cannot be used on persons with no fingers or toes, or any person under 18 years of age.
Warning: The results may be subject to motion or movement artifacts. The device was not tested on patients with gross tremors.
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.
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.
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.
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.
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.
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.
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.
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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These three words have the power to change lives. Between 8 to 10 million Americans are estimated to suffer from poor blood flow to the arms, legs and feet potentially leading to vascular disease, amputation or worse. Are you, or someone you know, suffering from Peripheral Arterial Disease (PAD)? Do you have pain in your legs when you walk at night, or even when resting? Do not ignore it. These warning signs are real and it’s time to get real help. Welcome to the LOVE YOUR LIMBS™ Campaign, by Bard Peripheral Vascular.