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A new stent, the PFM “Babystent”, has been developed in cooperation with the Humboldt University Berlin, Charité, and the PFM company. The purpose of this new stent technology is the development of a small stent which can be implanted in neonates without the need for surgical removal throughout the individual’s life. The minimal sheath diameter needed for implantation of this premounted stent is 4 French gauge. The stent diameter can be redilated from 4 to 23 mm in the patient.
After a 14 month experimental study period in an animal model the first human implantation was performed in a 5 month old preterm baby, weighing 2.6 kg. The Babystent was inserted into a subtotally occluded innominate vein. The stenoses caused severe venous congestion and occurred after complete occlusion of the superior caval vein due to a longstanding central line. The decision to implant the new Babystent was made after several unsuccessful attempts at treatment by surgical thrombectomy, two attempts of interventional ballooning, and surgical venoplasty.
The implantation of a stent 4 mm in diameter and 8 mm in length was uneventful. Further redilations of the stent to its maximum diameter will be necessary. The implantation of the PFM-Babystent is an alternative to balloon dilation for the treatment of arterial or venous stenoses in neonates. Further investigations on the long term follow up are needed to assess the stent function after several redilations over a lifelong period.