Clinical Problem

Unmet Clinical Need

 

 

Unmet Clinical Need

There are an estimated 3 million patients in the U.S. who suffer from mitral regurgitation with an additional 250,000+ new patients diagnosed annually.  In Western Europe the number is comparable and other medically advanced countries around the world add to this addressable patient population. 

As the only treatment currently available requires open heart surgery, valve repair is not considered until valve disease has progressed and the patient has become significantly symptomatic.  Unfortunately by that time co-morbidities including congestive heart failure (CHF), atrial fibrillation (AF), and advanced cardiovascular disease, renders many patients at "high risk" and ineligible for surgery. 

Surgical Annuloplasty

In 2009 approximately 39,000 patients in the U.S. and 34,000 patients in Western Europe had a surgical annuloplasty procedure.  Minimally invasive transcatheter procedures are usually associated with much lower mortality and morbidities.  QuantumCor's transcatheter approach will provide a therapeutic option for patients ineligible for surgery and as physicians become more comfortable we believe they may begin offering it to patients earlier in their disease process, before co-morbidities cause un-reversible cardiac damage.   

 

 

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CAUTION:  Investigational Device, Limited by Federal (U.S.) Law to Investigational Use