FDA approves Wayne company's dissection repair device

The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday. The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels. "Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute…
Source: bizjournals.com Health Care News Headlines - Category: Health Management Authors: Source Type: news

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Semin intervent Radiol 2019; 36: 133-136 DOI: 10.1055/s-0039-1688428The incidence of posttransplant hepatic arterial stenosis (HAS) has been reported in 5 to 10% of orthotopic liver transplants and, left untreated, can lead to hepatic arterial thrombosis. Most vascular complications develop less than 3 months after initial transplant, with thrombosis representing over half of all complications. There has been a trend toward minimally invasive, endovascular techniques for treating HAS with angioplasty and stenting. In one review of endovascular therapies for HAS, primary technical success was achieved in 95% of the interven...
Source: Seminars in Interventional Radiology - Category: Radiology Authors: Tags: Review Article Source Type: research
Balloon catheters have revolutionized the treatment of vascular diseases, but when they’re used to push plaque against the walls of vessels tears can form. These tears can have significant impact on the integrity and hemodynamics of vessels and...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Radiology Vascular Surgery Source Type: blogs
The use of endovascular techniques such as angioplasty and stent placement to treat chronic mesenteric ischemia (CMI) has become an effective alternative to open surgical repair, with decreased risk of complications and satisfactory success rates (1). However, extensively calcified lesions can be technically challenging to navigate, have higher restenosis rates, and may be unamenable to these techniques secondary to calcific balloon expansion limitations (1). Orbital atherectomy devices have been successfully used to treat severely calcified and stenotic lesions in peripheral arterial disease (PAD) as well as coronary lesions (2).
Source: Journal of Vascular and Interventional Radiology : JVIR - Category: Radiology Authors: Tags: Letter to the Editor Source Type: research
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017. The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news
ConclusionsRepair of CoA, even with associated transverse arch hypoplasia, by REEEA through left thoracotomy has a low mortality, low reintervention rate, and low incidence of late hypertension.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
This report aimed to present the long-term follow-up results of the management of superior vena cava (SVC) rupture during balloon angioplasty in an attempt to relieve SVC obstruction as a result of hemodialysis (HD) catheter-related central vein stenosis. Patient concerns: We present a case of a 42-year-old woman with end-stage renal disease on HD for 4 years, initially from an autogenous fistula for 2.5 years and then from a right internal jugular vein (IJV) catheter. She presented with clinical manifestations of SVC obstruction (dilated anterior chest wall and abdominal wall veins and facial swelling), which progresse...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research
One-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) successfully achieved both its primary and secondary endpoints. The Wayne, PA-based company announced the results at the 15th annual VIVA conference in Las Vegas. The company said this is the first peripheral vascular study to enroll patients with 100% dissected vessels, the TOBA II study, was conducted at 33 U.S. and European sites to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disea...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
We describe two cases of supravalvular aortic stenosis at the anastomotic site as an early complication of the arterial switch operation. Both patients underwent balloon angioplasty of the supravalvular aorta with improvement in postangioplasty gradients and angiographic appearance. Both patients at short-term follow-up had persistent improved gradient without need for further intervention.
Source: Annals of Pediatric Cardiology - Category: Cardiology Authors: Source Type: research
This study aims to evaluate reintervention rates and its predictors using a strategy of resection with extended end-to-end anastomosis (REEEA) via left thoracotomy.MethodsA retrospective analysis was performed for all patients who underwent isolated CoA repair or CoA and simultaneous VSD repair via REEEA between Jan 2000-Dec 2015. Patients with complex congenital heart disease were excluded. Transverse arch hypoplasia was defined as echocardiographic z-score
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
This study aims to evaluate reintervention rates and its predictors using a strategy of resection with extended end-to-end anastomosis (REEEA) via left thoracotomy. METHODS: A retrospective analysis was performed for all patients who underwent isolated CoA repair or CoA and simultaneous VSD repair via REEEA between Jan 2000-Dec 2015. Patients with complex congenital heart disease were excluded. Transverse arch hypoplasia was defined as echocardiographic z-score
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Ann Thorac Surg Source Type: research
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