PediaStent is pioneering the first bioresorbable stent specifically engineered for children with congenital heart disease. The CardiaZn features a novel zinc alloy that supports vessels as they heal, then safely dissolves. No more open heart surgery, no more permanent implants.
A survey of pediatric cardiologists cited in Identifying Gaps in Technology for Congenital Interventions found that bioresorbable stents are the most urgently needed device in pediatric cardiology.
Currently, physicians are left with two options: permanent metal stents or open-heart surgery. Metal stents limit vessel growth as children develop, always requiring repeated procedures to expand the stent and maintain blood flow. Each intervention exposes children to additional anesthesia and radiation. Metal stents also permanently eliminate natural vessel pulsatility, a critical aspect of normal vascular function. Open-heart surgery carries high risks, long ICU stays, and frequent need for additional procedures.
Repeated exposure to general anesthesia
Cumulative radiation exposure from fluoroscopic imaging
Vascular injury and restenosis risk
Progressive vessel trauma from serial dilation procedures
Increased risk of thrombosis and scar tissue formation
PediaStent is advancing a novel zinc-based alloy platform designed to provide temporary vessel scaffolding during critical healing periods, then gradually and safely resorb on its own, leaving no permanent implant behind and no further intervention required.
For approximately the first six months post-implantation, the CardiaZn maintains its peak radial strength, providing structural support of the diseased and dilated vessel. After six months, the stent's cells are designed to detach, allowing the vessel to grow normally while the CardiaZn continues to biodegrade in a benign fashion. The zinc alloy in the CardiaZn provides similar radial strength to stainless steel stents and overcomes the disadvantages of other bioresorbable stents that have failed in adults to date.
Engineered specifically for pediatric anatomy where future vessel growth is expected.
Provides acute mechanical scaffolding while avoiding a permanent metallic implant.
Built on a proprietary zinc alloy platform optimized for biocompatibility and controlled degradation.
PediaStent has received FDA Breakthrough Device Designation, was among the first companies invited into the FDA's TAP program, and is backed by a $3.4M NIH Fast Track SBIR award.