Interventional Atrial Septal Defect Closure Using a Totally Bioresorbable Occluder Matrix

Jux, Christian; Bertram, Harald; Wohlsein, P.; Bruegmann, Michael; Paul, Thomas

doi:10.1016/j.jacc.2006.02.057

Cited by 73 publications

(78 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Preclinical experiments have demonstrated more rapid and complete endothelialization of this matrix than with non-heparin-coated devices, with a low immune response during gradual absorption and replacement by host tissue. 22,23 In the present study, we report the first clinical use of the BioSTAR device in patients with a clinically significant atrial-level shunt. Our results demonstrate a high rate of shunt closure at both 30 days and 6 months.…”

Section: Discussionmentioning

confidence: 89%

“…3,19 -21 The device is coated with a heparin benzalkonium chloride complex (Celsus, Cincinnati, Ohio), which in animal experiments reduced protein and blood cell deposition and thrombus formation. 22 BioSTAR has a self-centering mechanism that consists of nitinol microsprings connected between the left and right atrial umbrellas (Figure 1). The collagen matrix is rapidly incorporated into the atrial septum, which results in a low profile and early sealing of the defect.…”

Section: Clinical Perspective P 1967mentioning

confidence: 99%

“…The collagen matrix is rapidly incorporated into the atrial septum, which results in a low profile and early sealing of the defect. 22,23 Gradual remodeling occurs over a period of Ϸ24 months, during which the collagen is absorbed and replaced by host tissue. 22,23 The BioSTAR Evaluation STudy (BEST) was designed to assess for the first time in humans the feasibility, safety, and efficacy of the BioSTAR septal occluder in the closure of PFO and ASD.…”

Section: Clinical Perspective P 1967mentioning

confidence: 99%

See 2 more Smart Citations

BioSTAR Evaluation STudy (BEST)

Mullen

Hildick‐Smith²,

Giovanni³

et al. 2006

Circulation

Self Cite

130

View full text Add to dashboard Cite

Background-The use of permanent synthetic implants to close atrial septal defects (ASD) and patent foramen ovale (PFO) has a number of limitations, including late complications and the limiting of transeptal access to the left heart should it be required for the later treatment of acquired heart disease. BioSTAR is a novel, bioabsorbable, atrial septal repair implant. This phase I pilot study evaluates the feasibility, safety, and effectiveness of BioSTAR for the first time in humans. Methods and Results-We conducted a prospective, open-label, multicenter clinical study in 58 patients aged 28 to 68 years who had a clinically significant ASD or PFO. Percutaneous shunt closure was undertaken with the BioSTAR septal repair implant. Successful device implantation was achieved in 57 (98%) of 58 patients. Closure at 30 days and 6 months, assessed by contrast transthoracic echocardiography, was 48 (92%) of 52 and 54 (96%) of 56, respectively. There was no evidence of a clinically significant response to the device. Transient atrial arrhythmia occurred in 5 patients after implantation. No major safety issues were observed. Conclusions-This study demonstrates the feasibility, safety, and effectiveness of BioSTAR for the closure of ASD and PFO in humans with a high rate of early and complete shunt closure. BioSTAR is a novel septal repair implant designed to provide biological closure of atrial-level defects using the patient's natural healing response. Because 90% to 95% of the implant is absorbed and replaced with healthy native tissue, future access to the left atrium may be achieved.

show abstract

Section: Discussionmentioning

confidence: 89%

Section: Clinical Perspective P 1967mentioning

confidence: 99%

Section: Clinical Perspective P 1967mentioning

confidence: 99%

See 1 more Smart Citation

BioSTAR Evaluation STudy (BEST)

Mullen

Hildick‐Smith²,

Giovanni³

et al. 2006

Circulation

Self Cite

130

View full text Add to dashboard Cite

show abstract

“…The discontinued STARFlex evolved to be the BioSTAR by substituting the conventional polyester fabric for a porcine type I collagen matrix with a heparin-coated surface [61,72]. The bioengineered collagen provided 90% of the structure, which started bioresorbing after 30 days and was fully replaced by host tissue at 2-year follow-up [72].…”

Section: Biostar and Biotrek (Discontinued)mentioning

confidence: 99%

“…The bioengineered collagen provided 90% of the structure, which started bioresorbing after 30 days and was fully replaced by host tissue at 2-year follow-up [72]. Eventually, only the 10% of a cobalt-based alloy framework remained (Figure 3).…”

Section: Biostar and Biotrek (Discontinued)mentioning

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

View full text Add to dashboard Cite

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

show abstract