Cordis Corporation - POWERFLEX PRO Percutaneous Transluminal Angioplasty (PTA) Catheter - Class 2 Recall

Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts

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Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts
ConclusionIn conclusion, higher AAC grade and anatomic factor related to the location of AVF (upper arm) were the important predictors of AVF dysfunction after PTA. These results could assist in tailoring surveillance programs and performing appropriate interventions for risky AVF.
Source: Clinical and Experimental Nephrology - Category: Urology & Nephrology Source Type: research
End-stage renal disease (ESRD) patients experiencing kidney failure typically require hemodialysis in order to artificially remove fluid and waste from blood and maintain appropriate electrolyte concentrations. For many patients on hemodialysis, an a...
Source: Medgadget - Category: Medical Devices Authors: Tags: Exclusive Medicine Vascular Surgery Source Type: blogs
Medtronic has won FDA approval to introduce its IN.PACT AV drug-coated balloon as a treatment option for failing arteriovenous (AV) fistulae. People with non-functional kidneys who undergo dialysis receive AV fistulae, which link an artery to a ve...
Source: Medgadget - Category: Medical Devices Authors: Tags: Medicine Vascular Surgery Source Type: blogs
Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for manufacturers and physicians this year, but an FDA approval this week marks a major step forward for this category of devices. The agency approved Medtronic's IN.PACT AV drug-coated balloon for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. AV fistulae are created and used to enable hemodialysis for patients with ESRD. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts
Conclusion: The segmented sharp recanalization is a practical strategy in treating angled long-segment CVO which is refractory to traditional guide wire transversal in hemodialysis patients.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research
ConclusionsThe results demonstrate safety of the study balloon in treating AV access stenosis. Nominal-diameter angioplasty was achieved at relatively low pressure in most study patients without the use of adjunctive procedures, and resumption of normal dialysis was achieved for all patients.
Source: Journal of Vascular and Interventional Radiology - Category: Radiology Source Type: research
The objective of this study was to compare the success rate and primary patency of thrombosed prosthetic vascular access grafts of the upper limb after thrombectomy and balloon dilation of stenotic segments at venous anastomotic sites using either paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters or plain balloon angioplasty catheters.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
Authors: Bountouris I, Kritikou G, Degermetzoglou N, Avgerinos KI Abstract The number of patients in dialysis increases every year. In this review, we will evaluate the role of percutaneous transluminal angioplasty (PTA) according to patency of arteriovenous fistula and grafts. The main indication of PΤΑ is stenosis> 50% or obstruction of the vascular lumen of an arteriovenous fistula and graft. It is usually performed under local anesthesia. The infection rate is as low as the number of complications. Fistula can be used in dialysis in the same day without the need for a central venous catheter. Prima...
Source: International Journal of Vascular Medicine - Category: Cardiology Tags: Int J Vasc Med Source Type: research
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