The Unmet Need

Aortic valve stenosis is the most common valvular heart disease in the developed world and the treatment of which is dominated by transcatheter aortic valve replacement (TAVR), representing a $5B market today. 

With the FDA approval of the low-risk patient group in recent years, TAVR valves are being implanted in younger and healthier patients each day further accelerating the growth of the market and treated patient population.  The ACC/AHA guidelines for patients with Structural Heart Disease were updated in 2020 and now state that any symptomatic patient over 65 years of age can be safely treated with either TAVR or surgery (Class I, LOE A).  We estimate that cumulatively, over 2 million US patients will be living with a bioprosthetic valve by 2032, with an increasing number of those patients outliving the lifespan of their implanted valve. 

When this occurs, there is a need to implant a new TAVR valve (‘redo’ TAVR) but this procedure is limited in application because of the many potential hazards the existing failed valve presents, such as acute obstruction of the coronary artery ostia.  Leaflet modification technology will be vital to mitigate procedural risks to enable patients to undergo the safest and most effective percutaneous treatment. 

Current methods to modify the leaflets before redo TAVR are complicated, time-consuming, and limited to simple leaflet laceration.  There are no commercially available methods for meaningful leaflet modification, what we refer to as ‘Leaflet Excision’, to excise the failed leaflets.  Leaflet excision technology will be vital to mitigate procedural risks to enable patients to undergo the safest and most effective percutaneous treatment in both the aortic and mitral positions.