Results of the Combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA Device for Percutaneous Closure of Patent Ductus Arteriosus

Moore, John W.; Greene, Jessica F.; Palomares, Salvadore; Javois, Alexander J.; Owada, Carl Y.; Cheatham, John P.; Hoyer, Mark V.; Jones, Thomas K.; Levi, Daniel S.

doi:10.1016/j.jcin.2014.06.019

Cited by 35 publications

(26 citation statements)

References 12 publications

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“…The Nit‐Occlud PDA device is a nitinol coil designed for PDA closure. The device specification has been previously described in detail . The Nit‐Occlud PDA device has a reverse‐cone shape having proximal and distal coils that is made to fit into the ductal ampulla and anchor to the pulmonary side of the PDA (Figure A).…”

Section: Methodsmentioning

confidence: 99%

“…The Nit‐Occlud is currently approved in the US for closure of PDAs smaller than 4 mm in infants greater than 5 kg and 6 months of age. The result of the combined United States multicenter pivotal and the continuing access study was reported in 2014, showing the excellent efficacy and safety of the Nit‐Occlud PDA for closure of small‐ to medium‐sized PDA …”

Section: Introductionmentioning

confidence: 99%

“…The result of the combined United States multicenter pivotal and the continuing access study was reported in 2014, showing the excellent efficacy and safety of the Nit-Occlud PDA for closure of small-to medium-sized PDA. 2 The Nit-Occlud PDA postapproval study (PAS) was designed to continue to evaluate the safety and efficacy of the Nit-Occlud PDA device in the postapproval phase. The objective of this study was to report the results of the Nit-Occlud PDA prospective PAS along with a comparison to the results of the pivotal and continued access trial.…”

Section: Introductionmentioning

confidence: 99%

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Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Kobayashi

Salem

Forbes

et al. 2018

Cathet Cardio Intervent

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Objectives To report the results of the Nit‐Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. Background The Nit‐Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. Methods The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported. Results Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device‐related adverse events. Conclusions The Nit‐Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device‐related adverse events in a large cohort of three clinical trials.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Kobayashi

Salem

Forbes

et al. 2018

Cathet Cardio Intervent

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“…Historical experience has offered one potential solution in mature device areas (e.g., objective performance criteria), and with more data collected in registries, historical data can be more powerful and more nimble. 39 Another potential use of prospective registry data is matching at the time of procedural hospitalization to establish more meaningful comparisons, particularly when randomization is not possible.…”

Section: General Principles Of Registry-based Cardiovascular Device Ementioning

confidence: 99%

Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet)

Zeitler

Al‐Khatib

Drozda

et al. 2016

American Heart Journal

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The Medical Device Epidemiological Network Initiative (MDEpiNet) is a public-private partnership between the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and participating partners. The Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) program is an MDEpiNet-sponsored program which aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle (TPLC). To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included four areas of cardiovascular medicine intended to cultivate interest in four MDEpiNet Disease Specific/Device Specific Working Groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the Working Groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program.

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“…Transcatheter closure of a patent ductus arteriosus (PDA) is performed since almost 50 years, starting with Porstmann's ivalon plug in 1967 . The interventionalist's armamentarium nowadays consists of a wide range of various occluder types and coils, mostly nitinol‐based and self‐expanding . The closing procedure itself is considered a standard procedure in most pediatric cath labs with excellent results .…”

Section: Introductionmentioning

confidence: 99%

Closure of very large PDA with pulmonary hypertension: Initial clinical case‐series with the new Occlutech^® PDA occluder

Lehner

Ulrich

Happel

et al. 2016

Cathet Cardio Intervent

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Results of the Combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA Device for Percutaneous Closure of Patent Ductus Arteriosus

Abstract: Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC.

Cited by 35 publications

References 12 publications

Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet)

Closure of very large PDA with pulmonary hypertension: Initial clinical case‐series with the new Occlutech^® PDA occluder

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Results of the Combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA Device for Percutaneous Closure of Patent Ductus Arteriosus

Abstract: Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC.

Cited by 35 publications

References 12 publications

Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet)

Closure of very large PDA with pulmonary hypertension: Initial clinical case‐series with the new Occlutech® PDA occluder

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Product

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Closure of very large PDA with pulmonary hypertension: Initial clinical case‐series with the new Occlutech^® PDA occluder