NMT Medical

NMT Medical is a pioneer in the field of non-surgical repair of structural heart defects in children and adults. Over 32,000 septal defects have been closed using our proprietary technology.

Clinical Trials and Regisisties

CLOSURE I Clinical Trial was a prospective, multi-center, randomized, controlled trial to evaluate the safety and efficacy of STARFlex® Septal Closure System versus Best Medical Therapy in patients with a stroke and/or transient ischemic attack (TIA) due to presumed paradoxical embolism through a patent foramen ovale (PFO).  The primary objective of this study is to determine whether the STARFlex® Septal Closure System will safely and effectively prevent a recurrent embolic stroke/TIA and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compare to best medical therapy.

BioSTAR® evaluation Study (BEST) was a prospective, multicenter, phase I clinical trial to evaluate the feasibility, efficacy, and safety of the BioSTAR® for the closure of atrial-level shunts in 58 patients aged 28 to 68 years who had a clinically significant ASD or PFO. Percutaneous shunt closure was undertaken with the BioSTAR® septal repair implant. Successful device implantation was achieved in 57 (98%) of 58 patients. Closure at 30 days and 6 months, assessed by contrast transthoracic echocardiography, was 48 (92%) of 52 and 54 (96%) of 56, respectively.

The BRAVO Registry is a multi-center registry providing long-term outcome data in patients who received a BioSTAR® septal repair implant to close a PFO. The Registry is conducted at selected institutions across Austria, Belgium, Germany, Italy, Ireland, Switzerland, United Kingdom and Canada. This observational registry is focusing on gathering safety and long term device performance data on approximately 200 patients following BioSTAR® implant. Enrollment in the registry has been closed and the collection and verification of the performance data remains ongoing.

BASIC BioSTAR® ASD Registry Children the primary objective of the registry is to collect clinical outcome data during routine clinical management of pediatric patients who have had Atrial Septal Defect (ASD) closure with the BioSTAR® septal repair implant. This registry will evaluate efficacy and safety of ASD closure with BioSTAR®. The BASIC Registry is being conducted at a selected group of pediatric centers across Germany and Switzerland. Patients less then 18 years of age, diagnosed with having a centrally located secundum ASD no greater than 16 mm in diameter and considered to be suitable for closure with BioSTAR® are enrolled in the registry. Currently 70 enrolled patients continue their routine post-implant follow-up in the registry and the collection and verification of the performance data is on-going.