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.


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.