CardioSEAL

A residual VSD following surgical closure occurs in 10% to 40% of patients depending on its location (43). Selected patients are suitable for a transcatheter approach. Interventional closure of selected muscular VSD has been possible for some years using the Rashkind (44) and subsequent generation devices (Clamshell, CardioSEAL). Currently the Amplatzer muscular,... 

Congenital heart disease (CHD) occurs in approximately 25 000 births per year in the United States. An atrial septal defect (ASD) is a spedfic form of CHD and is the third most common type of defect. Many people suffer from this disorder and in many cases it is only detected when the patient reaches middle age. Effective and efficient methods of repair are therefore needed to minimize the risks associated with traditional methods of ASD repair. In recent years, transcatheter closure methods for secundum type ASD have been developed. Currently the Amplatzer Septal Occluder, the Gore Helex Septal Occluder and the NMT Medical CardioSEAL-STARFiex Septal Occlusion systems have received FDA approval for ASD repair, the first of these only in 2001. This indicates that the use of these devices is still in its infancy. It can therefore be assumed that much more can be done to develop improved and more effective closure devices. It is the purpose of this chapter to describe ASDs and to outline the available technology with regard to transcatheter ASD repair devices. Hie discussion will centre around their construction and functioning, with special reference to their textile component. 

The original Clamshell device was modified to become the CardioSEAL septal repair implant. This was NMT Medical, Inc. s first attempt at developing an ASD repair device. The STARFlex septal repair implant has been considered to be a third-generation CardioSEAL device. Up until 2009, the CardioSeal device was available commercially both in Europe and the United States, while the STARFlex was commercially available in Europe oniy.36,39,40 2001 the CardioSEAL device was approved by the FDA for... 

CardioSEAL /STARFlex devices were composed of MP35N metal, which formed the framework of the square umbrella-shaped disks, connected in the centre. Knitted polyester (Dacron ) fabric was attached to this metal framework (see Fig. 18.9) by means of polyester sutures. MP35N was used in these devices since this alloy is compatible with MRI used to perform the procedure. The CardioSEAL was available in 17, 23, 28, and 33 mm sizes (diagonal diameter), while the STARFlex was... 

Image of the CardioSEAL (left), STARFlex (centre) and BioSTAR (right) devices formerly available from NMT Medical, Boston, MA. ... 

CardioSEAL /STARFIex MP35N alloy with knitted Small to medium Self-centering Double patch... 

Palacios IF. Closure of interatrial communications using the CardioSEAL/ STARFlex devices. In S. J. D. Brecker, ed. Percutaneous Device Closure of the Atrial Septum. United Kingdom Informa Heathcare 2006. 

Butera G, Carminati M, Chessa M, Delogu A, Drago M, Piazza L, Giamberti A and Frigiola A. CardioSEAL/STARflex versus amplatzer devices for percutaneous closure of small to moderate (up to 18 mm) atrial septal defects. Am Heart J 2004 9 148(3) 507-510. 

Landzberg MJ. CardioSEAL , CardioSEAL-STARFlex and PFO-star closure of PFO. In H. C. Herrmann, ed. Contemporary Cardiology Interventional Cardiology Percutaneous Noncoronary Intervention. Humana Press 2005. 10.1385/1-59259-898-6 131. 

Latson LA. The CardioSEAL device History, techniques, results. J Interv Cardiol 1998 11(5) 501-505. 

CardioSEAL septal repair implant - Technology Approach - NMT Medical [Internet] [cited 2009 2 April 2009]. Available from http //www.nmtmedical. com/technology.aspx id=90. 

CardioSEAL Septal Occlusion System with Qwik Load Summary of Safety and Effectiveness Data [Internet] FDA [cited 2009 10 November 2009]. Available from http //www.accessdata.fda.gov/cdrh docs/pdEP000049b.pdf. 

Taaffe M, Fischer E, Baranowski A, Majunke N, Heinisch C, Leetz M, Hern R, Bayard Y, Btlscheck F, Reschke M, Hoffmann I, Wunderlich N, Wilson N and Sievert H. Comparison of three patent foramen ovale closure devices in a randomized trial (amplatzer versus CardioSEAL-STARflex versus helex occluder). Am J Cardiol 2008 5/1 101(9) 1353-1358. 

Taaffe, M., Fischer, E., Baranowski, A., Majunke, N., Heinisch, C., Leetz, M., Hein, R., Bayard, Y., Buscheck, F., Reschke, M., Hoffmann, L, Wunderhch, N., Wilson, N., Sievert, H., 2008. Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). American Journal of Cardiology 101, 1353-1358. 

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