NeoChord, a medical device firm I first wrote about in 2007, made a top 10 list this week on the Medical Device and Diagnostic Industry news site.
Patients in the United States enjoy some of the best medical care in the world, but many observers worry that the country's regulatory environment is pushing medical innovation to other shores. Whether you believe FDA oversight is too stringent, too lax, or strikes the right balance, there are numerous medical devices that have achieved CE Marking, but aren't yet FDA approved.
NeoChord's DS1000 made the list. It earned a CE Marking in December 2012 but does not have FDA approval.
The Eden Prairie-based NeoChord surfaced locally in 2007, when it licensed technology designed byMayo Clinic cardiac surgeons Dr. Richard Daly and Dr. Giovanni Speziali. Speziali was named as the company's chief medical officer in 2013.
The NeoChord DS1000 device is used to treat a heart condition called mitral regurgitation. Mitral regurgitation means the valve or leaflet that controls the flow of blood from the left atrium to the left ventricle is not working properly.
Treatment typically consists of “cracking the chest,” stopping the heart and doing surgery. NeoChord's approach is much less invasive and can be done on a beating heart.
A tool is inserted between the ribs and into the heart. Then it is used to attach a chord to the faulty valve leaflet, which is tethered to the heart.
The market for less invasive techniques for mitral valve repair has been estimated at more than $2 billion.