NMT History

The foundations of NMT Medical are rooted in the first transcatheter closures of heart defects in the mid eighties.  Working with key thought leaders of the day, such as James Lock, MD; William Hellenbrand, MD; Charles Mullins, MD, the first truly successful transcatheter closure device – The Clamshell Umbrella – was developed and used in a broad clinical trial.  One result was the first PFO closure procedure ever performed, in 1989 at Children’s Hospital Boston.  The Clamshell program and technology were owned by CR Bard, Inc.  In the early to mid nineties, efforts were taken to transfer the technology base out of Bard and into a smaller, start up company led by leaders of the project team.  The effort was successful, the entire program moving in 1996 to NMT Medical, and several of the leaders of that effort remain at NMT to this day.  Initially backed by venture capital, NMT went public in late1996, trading as NMTI on the NASDAQ exchange.

Once situated at NMT, IPO proceeds funded major efforts to refine the device into the occluders of today. R&D efforts directed at both evolving CardioSEAL^® (1996) to STARFlex^® (1998) were completed.  Improvements in ease of use of the device have been continuous since that time.   Importantly, NMT recognized the value of a bioabsorbable device early in its history.  A bioabsorbable device development program was initiated in 1999 in collaboration with the late Gerd Hausdorf, MD.  Today, NMT Medical is the only company with a commercially approved bioabsorbable device, the BioSTAR^® bioabsorbable septal repair implant, and a second bioabsorbable device, BioTREK™, in pre-clinical studies.

A fundamental philosophy that has guided NMT since its inception is acquiring clinical science to provide patient benefit.  NMT is the recognized leader in clinical studies of transcatheter occluders.  Landmark clinical trials were initiated in Atrial Septal Defect, Patent Foramen Ovale, Ventricular Septal Defect and other hi-risk congenital heart defects.  The CardioSEAL^® septal repair implant received the CE mark in 1996, the first device to ever do so.  Quickly afterward, the STARFlex^® septal repair implant earned the CE mark in 1998.  In early 2000, NMT became the first cardiology device company to gain FDA commercial approval for PFO closure when it earned the humanitarian device exemption approval for recurrent stroke patients with PFO who had failed warfarin therapy.  This approval came on the heels of HDE approvals for both Ventricular Septal Defect and Fenestrated Fontan, two very high risk congenital heart defects.  In 2002, NMT earned a full PMA approval for congenital muscular ventricular septal defects (VSD).  In 2009, NMT received FDA approval for STARFlex^® septal repair implant for muscular ventricular septal repair.   

NMT continues to lead the industry, sponsoring several innovative clinical trials in recent years, including the CLOSURE I  PFO Stroke TIA study; the BEST BioSTAR^® study;  MIST I – the first randomized trial exploring PFO and migraine with aura; and MIST III, a continuation study of MIST I.  NMT products have been featured at major interventional cardiology meetings worldwide since 1998, including TCT, PICS and the EuroPCR meeting.

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