ASD and PFO closure with the Solysafe septal occluder—Results of a prospective multicenter pilot study

Ewert, Peter; Söderberg, Bjoern; Dähnert, Ingo; Hess, Otto M.; Schuler, Gerhard; Bussmann, Christiane; Bernhard, Jérôme; Sick, Peter

doi:10.1002/ccd.21360

Cited by 23 publications

(19 citation statements)

References 41 publications

(86 reference statements)

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“…In a pilot study of the Solysafe in 15 patients with ASD diameters 10-21 mm, no major complications occurred and 100% had complete closure at 6-month follow-up [36]. In a pediatric cohort of 37 patients, a success rate of 87% was reported due to several cases of absent aortic rims, but the closure rate remained 100% at 6-month follow-up [37].…”

Section: Solysafe Septal Occludermentioning

confidence: 97%

“…The Solysafe Septal Occluder was a self-centering device consisting of two polyester patches and eight wires made of Phynox, a cobalt-based alloy, which attached to two wire holders on both ends [36]. The wires were arranged in helical form so that when both device ends were joined together by a snap-lock mechanism, a flat double-disk device would form in a flower-like shape (Figure 1).…”

Section: Solysafe Septal Occludermentioning

confidence: 99%

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Historical developments of atrial septal defect closure devices: what we learn from the past

Nassif

Abdelghani

Bouma

et al. 2016

Expert Review of Medical Devices

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Introduction: Since King and Mills' pioneering work in percutaneous closure devices of secundum atrial septal defects (ASD) four decades ago, developments in device shape, material and implantation technique led to adoption of percutaneous ASD closure as current treatment of choice. Not only was the feasibility of such a percutaneous procedure tested altogether, but pursuing the ideal device in terms of safety and efficacy became priority. Areas covered: In this review we present the historical development of ASD devices in design, material and technique with clinical data, and provide the future perspectives in percutaneous ASD closures. Expert opinion: An 'ideal device' requires complete defect closure with negligible risk of complications using a safe, straightforward delivery technique with repositioning and retrieving properties. Some of the devices currently at hand come close to fulfilling these criteria, however none seem to provide those prerequisites completely. By understanding how challenges in device development were overcome in the past, new insights into future improvements are given. ARTICLE HISTORY

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Section: Solysafe Septal Occludermentioning

confidence: 97%

Section: Solysafe Septal Occludermentioning

confidence: 99%

Historical developments of atrial septal defect closure devices: what we learn from the past

Nassif

Abdelghani

Bouma

et al. 2016

Expert Review of Medical Devices

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“…Subsequently a number of other devices were described and these include: original buttoned device [142,143] 160], centering on demand buttoned device to center the device in the ASD when required [161], fenestrated Amplatzer device to keep atrial septal defects open to maintain cardiac output [162], hybrid buttoned device to address closure of defects with associated with atrial septal aneurysm [163], cribriform device to occlude multiple or fenestrated ASDs [164], BioSTAR [165,166], nanoplatinum coating to prevents nickel release from Amplatzer devices, thus averting Kounis syndrome [167], Solysafe Septal Occluder device [168], BioTREK [169], Occlutech [170], ATRIASEPT I-ASD device [171], ATRIASEPT II-ASD and ULTRASEPT [172], The pfm ASD-R devices [173] and others. Other devices such as Cardi-O-Fix Septal Occluder, Heart R Septal Occluder, cocoon, LifetechScientific device (also called sears device), some manufactured in China and others that may have escaped detection by our literature search and may be in development.…”

Section: Atrial Septal Defectmentioning

confidence: 99%

“…Vast majority of the devices described in the ASD section, as and when they became available, were used to close PFOs. Existing ASD closure devices were modified or new devices designed to address the anatomic features of the foramen ovale and these include, Amplatzer PFO occluder [180], Cardia devices (PFO-Star and several of its subsequent generations) [172,181], Premere occluder [182], Occlutech septal occluder [183], Coherex Flat stent [184], pfm PFO-R [173], Solysafe PFO occluder [168] and others. Some of these devices are in clinical trials in and/or outside the US, and none are currently approved by FDA for general clinical use.…”

Section: Patent Foramen Ovalementioning

confidence: 99%

Historical Aspects of Transcatheter Treatment of Heart Disease in Children

Rao¹

2012

Pediat Therapeut

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The very first transcatheter intervention to treat congenital cardiac defects was reported by Rubio-Alvarez et al. [1] in 1953, when they performed pulmonary valvotomy using a modified ureteral catheter. A decade later Dotter, Rashkind, Porstmann and their associates described progressive dilatation of peripheral arterial stenotic lesions, balloon atrial septostomy and transcatheter occlusion of patent ductus arteriosus, respectively. The purpose of this review is to present these and other historical developments of catheter-based interventions in the treatment of heart disease in children. Historical aspects of 1. balloon angioplasty/valvuloplasty of valvar pulmonary stenosis, valvar aortic stenosis, fixed subaortic stenosis, native aortic coarctation, postsurgical aortic recoarctation, branch pulmonary artery stenosis, mitral stenosis, cyanotic heart defects with pulmonary oligemia, stenotic bioprosthetic valves, congenital tricuspid and mitral stenosis, truncal valve stenosis, subvalvar pulmonary stenosis, supravalvar pulmonary stenosis (congenital membranous or postoperative), stenosis of the aorta (Leriche syndrome, atherosclerotic and Takayasu's arteritis), baffle obstruction following Mustard or Senning procedure (both systemic and pulmonary venous obstructions), superior and inferior vena caval obstructions, pulmonary vein stenosis, pulmonary veno-occlusive disease, vertical vein stenosis in total anomalous pulmonary venous connection, pulmonary venous obstruction following repair of total anomalous pulmonary venous obstruction, specially designed pulmonary artery bands, cor triatriatum, cor triatriatum dexter, and coronary artery stenotic lesions that develop after Kawasaki disease; 2. stents to enlarge stenotic lesions of branch pulmonary arteries, systemic veins, systemic and pulmonary venous pathways after Mustard procedure, aorta, right ventricular outflow conduits, pulmonary veins and native right ventricular outflow tract or to keep the ductus arteriosus open in patients with pulmonary atresia and hypoplastic left heart syndrome and maintaining patency of stenosed aorto-pulmonary collateral vessels, surgically created but obstructed shunts or acutely thrombosed shunts as well as covered stents; 3. transcatheter occlusion of cardiac defects comprising of atrial septal defect, patent foramen ovale, patent ductus arteriosus, ventricular septal defect and aortopulmonary window and 4. catheter-based atrial septostomy such as Rashkind balloon atrial septostomy, Park's blade atrial septostomy, balloon angioplasty of the atrial septum, trans-septal puncture and atrial septal stents were presented.

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“…Its feasibility for closure of secundum type ASDs and patent foramen ovale (PFOs) has been evaluated in clinical studies mainly for adult patients [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Interventional closure of atrial septal defects with the Solysafe Septal Occluder — Preliminary results in children

Kretschmar

Sglimbea

Dähnert

et al. 2010

International Journal of Cardiology

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ASD and PFO closure with the Solysafe septal occluder—Results of a prospective multicenter pilot study

Abstract: With the self-centering Solysafe Septal Occluder, PFOs, and ASDs with a stretched diameter of up to 21 mm can be effectively closed with very high occlusion rates.

Cited by 23 publications

References 41 publications

Historical developments of atrial septal defect closure devices: what we learn from the past

Historical developments of atrial septal defect closure devices: what we learn from the past

Historical Aspects of Transcatheter Treatment of Heart Disease in Children

Interventional closure of atrial septal defects with the Solysafe Septal Occluder — Preliminary results in children

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