Heart Repair

FDA Disclaimer

CardioSEAL^® and STARFlex^® are approved in the USA by the FDA specifically for the following indication:

Ventricular Septal Defect (VSD)

Both CardioSEAL^® and STARFlex^® Septal Repair Systems with QwikLoad are indicated for use in patients with complex ventricular septal defects (VSD) of significant size to warrant closure and who are considered to be at high risk for surgical closure based on anatomical conditions and/or based on overall medical condition.

High risk anatomical factors for surgical closure include patients:

requiring a left ventriculotomy or an extensive right ventriculotomy;

with a failed previous VSD closure;

with multiple apical and/or anterior muscular VSD’s (“Swiss Cheese Septum”); or

with posterior apical VSD’s covered by trabeculae.

BioSTAR^®, STARFlex^®, and CardioSEAL^® all carry the CE Mark and are commercially available in Europe. BioSTAR^® and CardioSEAL^® are commercially available in Canada. CardioSEAL^® and STARFlex^® are available for Ventricular Septal Defect (VSD) closure in the United States.

Heart Repair

FDA Disclaimer

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