HeartStitch Transapical Access and Closure Device Receives CE Mark Approval
April 12, 2018—HeartStitch, Inc. has received European CE Mark approval for its suture-based transapical access and closure device. The company expects to bring this product to market in Europe in Fall 2018.
According to the company, the HeartStitch device provides safe and effective percutaneous transapical access for structural heart procedures and reliable closure. The suture-based technique emulates surgical closure without the need for open heart surgery or limited thoracotomy access when repairing structural heart defects in the left heart.
HeartStitch also noted that it currently manufactures and markets the NobleStitch EL device under exclusive license from Nobles Medical Technologies II, Inc. (NMT2) for cardiovascular suturing and patent foramen ovale closure. NMT2 announced that results from the NobleStitch EL Italian registry were published online by Achille Gaspardone, MD, et al in EuroIntervention.