The ButtonSeal is an occlusive device which has been in use, in its current form or that of earlier generations, since the late 1980’s. FDA clinical trials were completed with the Buttoned device, an earlier generation of the ButtonSeal, in 1997. The clinical results were good and have been published extensively. In comparison to the Buttoned device, the ButtonSeal Device is more user friendly. The ButtonSeal is a centering on demand device; the centering mechanism is used in larger single defects and the same device is used without centering for atrial aneurysms with fenestrations or patent foramen ovale.

ASD
Scholarly work describing the correction of Atrial Septal Defects using the ButtonSeal and its previous generations:

Intermediate term results of phase I Food and Drug Administration Trials of Buttoned device occlusion of secundum atrial septal defects. Zamora R, Rao PS, Lloyd TR, Beekman RH, Sideris EB. JACC 31: 674-6, 1998

Buttoned Device Closure of Atrial Septal Defects. Rao PS, Sideris EB. J. Interven. Cardiol. 11: 467-483, 1998

Centering-on-Demand Buttoned Device: It’s Role in Transcatheter Occlusion of Atrial Septal Defects. Rao PS, Sideris EB, J. Interven Cardiol. 2001:14:81-89.

VSD
A publication describing the correction of Ventricular Septal Defects using the ButtonSeal and its previous generations:

The Role of the “Sideris” Devices in the Occlusion of Ventricular Septal Defects. E.B. Sideris, J. Haddad, P.S. Rao, Current Interv. Cardiol. Reports, 2001, 3:349-353.

PDA
Scholarly work describing the correction of Patent Ductus Arteriosus using the ButtonSeal and its previous generations:

Results of Transvenous Buttoned Device Occlusion of Patent Ductus Arteriosus in Adults. Rao PS, Kim SH, Rey C, Onorato E, Sideris EB. Am J Cardiol 8: 827-9, 1998

Follow-up Results of Transvenous Occlusion of Patent Ductus Arteriosus with the Buttoned Device. Rao PS, Kim SH, Choi JY, Rey C, Haddad J, Marcon F, Walsh K, Sideris EB. JACC 33: 820-6, 1999

Buttoned Device Occlusion of Patent Ductus Arteriosus. E.B. Sideris, P.S. Rao, Current Interventional Cardiology Reports. 2001, 3: 71-79

The Sideris Buttoned Device for Transcatheter Closure of Patent Ductus Arteriosus. E.B. Sideris, PS Rao, R. Zamora, J. Interven. Cardiol. 2001:14:239-246.

Follow-up results of transvenous occlusion of patent ductus arteriosus with the buttoned device. PS Rao, SH Kim, J-Y Choi, C. Rey, J. Haddad, F. Marcon, K. Walsh, EB Sideris. JACC 1999; 23: 526A

Other Studies
A case report describing the evolution of the ButtonSeal:

Buttoned device modifications; influence on feasibility, safety and effectiveness Rao PS, and Sideris EB. Cardiology in the Young. 2001:11 suppl, I, 970.