Heart graft transport system gains breakthrough device designation
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Bridge to Life Ltd. announced it received breakthrough device designation authorization from the FDA for its preservation, storage, monitoring and transportation system for heart grafts.
The transport system (LifeCradle) uses hypothermic, oxygenated, nutrient perfusion from the time of organ procurement until transplantation, according to a company press release.
The system utilizes a “plug-and-play” design for minimal user burden.
The transport system is used in tandem with the company’s machine perfusion system (Belzer MPS) and requires no blood or blood products, according to the release.
Breakthrough therapy designation is designed to expedite the development and review of therapies that are intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available therapies on a clinically significant endpoint.
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