Transcatheter aortic valve replacement(TAVR) may provide a treatment option for the inoperable or high-risk patients with aortic stenosis.

      While the world may view TAVR as an “overnight” success, the path to the present day application of this therapy has been decades in the making. In1989, Dr. Henning Andersen and his team performed the first preclinical implantation of a balloon-expandable heart valve. During the next 10 years, additional research occurred in this area and the field of percutaneous transluminal valvuloplasty to treat severe aortic stenosis. Edwards Life sciences embarked on its own transcatheter valve program in 1999.

     With this milestone-and the first human implants in the United States in2004 by Dr. William O’Neill—the progress toward a clinically feasible and commercially viable TAVR accelerated. This burst of activity perhaps contributes to the perception of the rapid development of this therapy. Edwards acquired the company Percutaneous Valve Technologies in 2004, and created a cohesive business and research entity in combination with its internal efforts already underway. This transaction enabled Edwards to accelerate the development of a breakthrough technology for patients with heart valve disease, particularly the many individuals unable to undergo traditional open-heart surgery to resolve their aortic valve disease.  

     In the following eight years, significant progress was made in the advancement of transcatheter valves via a series of robust clinical studies conducted around the world, continued refinement and innovation to the designs of the transcatheter valves and their delivery systems, the training of hundreds of clinicians and their respective Heart Teams around the globe and, most importantly, the treatment with the Edwards SAPIEN valves of more than 25,000 patients in need of transcatheter intervention for severe aortic stenosis.

      The landmark randomized controlled study, The PARTNER Trial, has provided key insights to both the surgical and interventional communities on the outcomes of patients with severe AS treated with standard therapy, transcatheter valve replacement and traditional open-heart surgery. These data have served as the basis of the introduction of this therapy to American patients, which began after receipt of approval from the FDA in Nov. 2011.Edwards is partnering with experienced TAVR clinicians from around the world to teach and guide their peers in performing this life-saving and life enhancing procedure. balloon-expandable TAVR should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery.