Table 2.
Pediatric cardiac medical devices FDA-approved through the Humanitarian Device Exemption (HDE) Pathway*.
| Device | Year | Company | Population/Indication | Supporting Clinical Data |
|---|---|---|---|---|
| Berlin Heart EXCOR® Pediatric Ventricular Assist Device (H100004) | 2011 | Berlin Heart, Inc | Children ≤16 years with class IV heart failure and listed for transplant in cardiogenic shock or slow progressive decline despite optimal support | Multi-center single arm cohort study (N=48) compared to retrospective cohort of children supported with ECMO and safety OPC. Supplemental data from compassionate-use implants (N=156). |
| Medtronic Melody® Transcatheter Pulmonary Valve and Ensemble Transcatheter Valve Delivery System (H08002) | 2010 | Medtronic, Inc | Pediatric and adult patients with original RVOT conduit ≥16 mm with dysfunctional RVOT conduits with a clinical indication for intervention due to PR>moderate or PS> 35 mm Hg | Multi-center single arm cohort study (N=90) of children and adults (ages 7–44 years); Supplemental data from OUS implants (N=68) also reviewed. |
| Debakey VAD Child Left Ventricular Assist system (H03003) | 2004 | Micromed Technology, Inc | Children age 5–16 years with BSA 0.7–1.5 with class IV heart failure refractory to medical therapy and listed for heart transplantation | None |
| Contegra® Pulmonary Valved conduit (H20003) | 2003 | Medtronic, Inc | Children <18 years requiring RVOT reconstruction due to pulmonary stenosis, TOF, Truncus Arteriosus, TGA-VSD, Pulmonary Atresia | Multi-center, prospective single arm cohort study (N=237) compared to homograft controls drawn from the literature. |
| Shelhigh Pulmonic Valve Conduit Model NR-4000 with “No- React®” Treatment (H980007) | 1999 | Shelhigh, Inc. | Infants or children up to age 4 years of age requiring replacement of a dysfunctional or absent pulmonary artery (TGA, TOF, Truncus Arteriosis, Pulmonary Atresia, or replacement for accelerated conduit failure) | European clinical experience which included 70 patients (47 were infants) |
| CardioSEAL® Septal Occlusion System (H990005) | 1999 | Nitinol Medical Technologies, Inc. | Children and adults with complex VSDs warranting closure due to size but cannot be closed with standard surgical trans-atrial or trans-arterial approaches because of location. | Single-center experience of 53 patients (median age 4 years) with complex VSDs |
| CardioSEAL® Septal Occlusion System (H990004) | 1999 | Nitinol Medical Technologies, Inc. | For the treatment of children and adults with complex single ventricle physiology who have undergone a fenestrated Fontan palliation procedure and require closure of the fenestration. | 3-center experience of 67 patients (median age 7 years) implanted for Fontan fenestration closure |
OPC, objective performance criteria; ECMO, extra-corporeal membrane oxygenation; OUS, outside the United States; RVOT, right ventricular outflow tract; TOF, Tetralogy of Fallot; TGA-VSD, transposition of the great arteries with ventricular septal defect; VAD, ventricular assist device; VSD, ventricular assist device
*
CardioSEAL and Amplatzer septal occluders were also originally HDE-approved for PFO closure however HDE approval was subsequently withdrawn by the FDA when the disease population affected was estimated to be >4,000 cases per year.