FDA grants de novo clearance to hemodialysis catheters from Avenu Medical, TVA Medical

The FDA today granted de novo clearance to a pair of companies that make catheters designed for hemodialysis, Avenu Medical and TVA Medical. The federal safety watchdog said the catheters are designed to create an arteriovenous fistula connecting veins and arteries for a less-invasive way to access the vascular system. Avenu’s device is called Ellipsys; TVA Medical makes the EverlinQ EndoAVF system. “Dialysis is a necessary and life-saving procedure for thousands of individuals. With today’s action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis,” Dr. Bram Zuckerman, director of the cardiovascular devices division of the FDA’s Center for Devices &Radiological Health, said in prepared remarks. The FDA said it granted clearance to Avenu’s device based on a 103-patient, non-randomized study in which 89.3% of patients met the criteria for a usable AV fistula within three months. Some 96.1% required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula. TVA Medical’s clearance was based on another non-randomized study of 60 patients, plus data from three other studies and clinical use of the device outside the U.S., the agency said. Fifty-two patients, or 86.7%, met the three-month usable fistula benchmark, with 96.7% requiring an addition procedure when the fistula was created and 29.3% needing an additional procedure i...
Source: Mass Device - Category: Medical Devices Authors: Tags: Catheters Dialysis Food & Drug Administration (FDA) Regulatory/Compliance Avenu Medical TVA Medical Source Type: news

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CONCLUSION: The Arch V SUPERA-LUX study is the first trial to evaluate whether SUPERA stent implantation and drug-coated balloon use can provide superior protection against restenosis compared to traditional angioplasty, bare metal stents and stent grafts in recurrent cephalic arch stenosis. Initial pilot results are encouraging but longer follow-up is required to truly test this technique. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov NCT03891693. PMID: 31621477 [PubMed - as supplied by publisher]
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Concept Medical’s MagicTouch AVF might have the “magic touch” when it comes down to nabbing breakthrough device designations. The proposed indication for the latest breakthrough device designation is for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure. Concept Medical said its first pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon was started in Singapore in 2018. Led by Principal Investigator, Dr. Tan Chieh Suai, a multi-disciplinary team of doctors ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
CONCLUSION: Our technique of retrieval may be suitable for cases of balloon rupture with a circumferential tear during percutaneous transluminal angioplasty. The technique enables less invasive retrieval and continuation of the percutaneous transluminal angioplasty thereafter. PMID: 31434523 [PubMed - as supplied by publisher]
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Arteriovenous fistulas for patients undergoing hemodialysis (HD) are at high risk of stenosis. Despite conventional balloon angioplasty (CBA), restenosis rates are high. The use of a drug-coated balloon (DCB) may offer an alternative to reduce restenosis.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Tags: Review article Source Type: research
Authors: DeGiovanni J, Son A, Salehi P Abstract We are reporting a case of venous thoracic outlet syndrome with recurrent subclavian vein thrombosis in the setting of an ipsilateral brachiocephalic arteriovenous fistula for hemodialysis that was malfunctioning due to the central vein obstruction. The patient also had a concomitant external jugular vein origin stenosis. Given her body habitus and aversion to recovery after traditional first rib resection, we elected for an alternative treatment with an external jugular vein to internal jugular vein transposition with balloon angioplasty of the stenosed external jugu...
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Publication date: Available online 21 June 2019Source: Journal of Vascular Surgery: Venous and Lymphatic DisordersAuthor(s): Cassius Iyad Ochoa Chaar, Navid Gholitabar, Issa Rezek, Randy Luciano, Jude ClancyAbstractSuperior vena cava syndrome is an uncommon but challenging complication of patients undergoing hemodialysis through upper extremity access as well as of patients with indwelling pacemakers. This case report and Video demonstrate the multidisciplinary management of a complex patient with hemodialysis access and indwelling pacemaker for whom multiple attempts at balloon angioplasty for superior vena cava syndrome ...
Source: Journal of Vascular Surgery: Venous and Lymphatic Disorders - Category: Surgery Source Type: research
CONCLUSION: Despite the invasiveness, direct atrial outflow procedures remain a valid alternative in carefully selected patients with adequate cardiopulmonary reserve. PMID: 31188045 [PubMed - as supplied by publisher]
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Authors: Tozzi M, Franchin M, Savio D, Comelli S, Di Maggio L, Carbonari L, Ebrahimi R, Fontana F, Piacentino F, Cervarolo MC, Palermo V, Piffaretti G Abstract BACKGROUND: We evaluated the safety and technical and clinical outcomes of angioplasty with a drug-coated balloon for the management of venous stenosis in arteriovenous grafts and arteriovenous fistulas in patients undergoing haemodialysis. METHODS: Data were obtained from an ongoing prospective, non-randomised registry conducted at three Italian centres. Patients were treated with a drug-coated balloon according to standard procedures in each participat...
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
DISCUSSION: The factors we have identified as linked to poor outcome may help to identify patients in whom a balloon angioplasty is unlikely to provide a durable outcome. This may prompt exploring alternative treatment or dialysis options at an early stage. PMID: 31084389 [PubMed - as supplied by publisher]
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
We describe a case of arteriovenous graft outflow stenosis, which led to complete thrombosis of the graft, which was rescued by surgical thrombectomy and stent graft placement across the venous end of the anastomosis with good results.
Source: Indian Journal of Nephrology - Category: Urology & Nephrology Authors: Source Type: research
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