The Natural Evolution of TAVR
Developing A Leaflet Modification System
Enabling Lifetime Management of Aortic Stenosis
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.
The Excision Medical Leaflet Excision System is designed to allow physicians to target and excise one or more aortic valve leaflets while also considering the hemodynamic needs of patients. Leaflet removal (or excision) will be key to properly mitigating the risk of coronary artery ostia obstruction, and debulking the existing valve prior to the redo TAVR, which may also offer additional benefits to the performance of the new valve.
Excision Medical is setting the stage for fast and effective valve replacement by designing the system to integrate into the workflow of TAVR procedures as the wave of secondary replacement approaches in the coming years. Leaflet Excision is the natural evolution of TAVR.
RF Excision Catheter
A unique patent pending leaflet modification technology for lifetime management of aortic stenosis.
Warning: Excision Medical is a development stage company and the
Leaflet Excision system is not Approved by the FDA
Excision vs. Laceration
26mm CoreValve in 29mm CoreValve (with commissural alignment)
David Wood, MD
VP of Operations
VP of Design
VP of Product Development
Scientific Advisory Board
Gary Roubin, MD PHD
Co-Founder, SAB Chair
Janarthanan Sathananthan, MD MPH
James McCabe, MD
Heart Institute at UW Medical Center
Adam Greenbaum, MD
Emory Structural Heart and Valve Center