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:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news

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Authors: Giannopoulos S, Armstrong EJ Abstract Introduction: Femoropopliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease. In this manuscript we review the literature on the application of newly approved devices in the treatment of atherosclerotic lesions at this segment. Areas covered: New drug-coating technologies provide sustained drug-eluting over time and better scaffolds are more resistant to the increased biomechanical stress at the femoropopliteal segment. Thus, the newer drug-eluting stents (i.e.Eluvia®), nitinol interwoven stents (i.e.Supera&...
Source: Expert Review of Cardiovascular Therapy - Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research
This study sought to assess exercise capacity and blood pressure response in asymptomatic patients long-term after CoA repair in relation to left ventricular and vascular function. Twenty-two CoA patients (age 30  ± 10.6 years) with successful surgical repair (n = 12) or balloon angioplasty (n = 10) between 3 months and 16 years of age with a follow-up of >  10 years underwent cardiopulmonary exercise testing at a mean follow-up of 23.9 years. Exercise capacity (peak oxygen uptake; VO2peak) and blood pressure response were compared t...
Source: Mammalian Genome - Category: Genetics & Stem Cells Source Type: research
AbstractRisk of superior vena cava (SVC) obstruction following repair of anomalous right upper pulmonary veins in children is unclear. The incidence and outcome of subclinical obstruction remained unknown. Retrospective single institutional study (07/1993 –02/2017) in a pediatric population (N = 42, median age 3.9-year, range 0.1–15.3 years). 33 (79%) children had repair without SVC translocation (“non-Warden”) and 9 (21%) had Warden-type surgery. Echocardiographic SVC obstruction was defined as (I) turbulent flow across SVC and (II) continuous flow pattern without return to b ase...
Source: Pediatric Cardiology - Category: Cardiology 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
AbstractAn extremely low birth weight infant (810  g) was born with pulmonary atresia, ventricular septal defect, and major aortopulmonary collateral arteries accompanied by pulmonary overcirculation, which eventually resulted in intestinal hypoperfusion and focal intestinal perforation from the very early stage of life. Based on the echographic f indings, we performed banding operations twice to regulate the pulmonary blood flow on day 2 and day 9. At 6 months of age, a definitive repair simultaneous with unifocalization of major aortopulmonary collateral arteries was performed. At 1 year of age, the right ...
Source: General Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
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 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
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
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