FDA approves Intact Vascular ’ s Tack dissection repair device

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, amputation or all-cause death, its primary safety endpoint, was 86.5%. The trial met its efficacy endpoint with a 79.3% primary patency rate at 12 months. And 92.1% of all dissections were completely resolved, according to results presented at last year’s Vascular InterVentional Advances conference in Las Vegas by principal investigator Dr. William Gray. Intact Vascular said the trial, which it touted as the first to enroll PAD patients with 100% dissected vessels, also showed 0.5% bailout stent rate and zero implant fractures. “FDA approval of the Tack endovascular system comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” president &CEO Bruce Shook...
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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CONCLUSIONS: PTX-ITSs showed significantly better suppression of late scaffold shrinkage and lower in-scaffold stenosis for up to 3 months. Additionally, PTX-ITSs exhibited high biocompatibility, which is comparable to ITSs. PMID: 32238644 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
Conclusions: These results suggest that endothelial depalmitoylation is regulated by the metabolic milieu and controls plasma membrane partitioning to maintain vascular homeostasis. PMID: 32233916 [PubMed - as supplied by publisher]
Source: Circulation Research - Category: Cardiology Authors: Tags: Circ Res Source Type: research
AbstractObjectivesCentral or peripheral venoarterial extracorporeal membrane oxygenation (va ECMO) is widely used in postcardiotomy cardiogenic shock (PCS). Available data suggest controversial results for both types. Our aim was to investigate PCS patients treated with either peripheral (pECMO) or central ECMO (cECMO) concerning their outcome.MethodsBetween April 2006 and October 2016, 156 consecutive patients with va ECMO therapy due to PCS were identified and included in this retrospective analysis. Patients were divided into cECMO and pECMO groups. Statistical analysis of risk factors concerning 30 ‐day mortality of ...
Source: Journal of Cardiac Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research
(American College of Cardiology) The results of VOYAGER PAD found that people with peripheral artery disease (PAD) who took the blood thinner rivaroxaban with aspirin after undergoing lower extremity revascularization -- a procedure to treat blocked arteries in the leg -- had a significant reduction in the risk of major adverse limb and cardiovascular events when compared with those receiving aspirin alone, according to a subgroup analysis from VOYAGER PAD presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
CONCLUSION: The extension assessment was carried out in more than 8 out of 10 cases. The use of antiplatelet antiaggregants was significant, which can be explained by the coexistence of divergent recommendations. The rapid clarification of recommendations is essential with the evolution of scientific data. PMID: 32241521 [PubMed - as supplied by publisher]
Source: Annales de Cardiologie et d'Angeiologie - Category: Cardiology Authors: Tags: Ann Cardiol Angeiol (Paris) Source Type: research
The new vascular low dose of rivaroxaban has gotten off to a slow start, but these new subgroup results may stimulate use in patients with diabetes and stable coronary or peripheral artery disease.Medscape Medical News
Source: Medscape Cardiology Headlines - Category: Cardiology Tags: Cardiology News Source Type: news
Conclusions: In statin-treated patients with recent ACS, risk of PAD events is related to lipoprotein(a) level and is reduced by alirocumab, particularly among those with high lipoprotein(a). Further study is required to confirm whether risk of VTE is related to lipoprotein(a) level and its reduction with alirocumab. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01663402. PMID: 32223446 [PubMed - as supplied by publisher]
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
AbstractPurposeTo investigate risk factors for severe bleeding during warfarin treatment, including the influence of sex, age, comorbidity and co-medication on bleeding risk.MethodsPatients initiating warfarin treatment between 2007 and 2011 were identified in the nationwide Swedish Prescribed Drug Register, and diagnoses of severe bleeding were retrieved from the National Patient Register. Hazard ratios (HR) with 95% confidence intervals (CI) for severe bleeding were estimated using multiple Cox regression adjusting for indications and including covariates age, sex, comorbidities and co-medications. Interactions between s...
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
New England Journal of Medicine, Ahead of Print.
Source: New England Journal of Medicine - Category: Internal Medicine Authors: Source Type: research
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