FDA gives clearance to HAART 300 Aortic Annuloplasty Device

The Food and Drug Administration has recently added one more device to the list of achieving market clearance from it. And this time, it is the HAART 300 Aortic Annuloplasty tool by the BioStable Science & Engineering. It is the first device to be made commercially accessible for the aortic valve repair. BioStable has launched the device to a finite number of important European heart centers after gaining a CE Mark sanction in 2016.

Aortic regurgitation can arise when the aortic annulus is feebly shaped, not allowing the leaflets of the valves to come together suitably. The design of the HAART 300 Aortic Annuloplasty equipment is dependent on widespread anatomical researches and reproduces the intricate 3D structure of the normal aortic valve. This device is developed to reshape, stabilize, and re-size the aortic annulus to reinstate valve competency and assist in preventing recurring aortic regurgitation. Valve repair is the benchmark surgical treatment in tricuspid and mitral valve disease owing to the verified patient advantages over valve replacement. Annuloplasty devices are well known as a significant part of successful heart valve repair.

Board member BioStable, Joe Cunningham, said, “We are extremely thankful for the mutual aid between the FDA and BioStable management team that permitted the company to achieve this market clearance prior than estimated, and we are looking forward to make HAART 300 Aortic Annuloplasty Device accessible to the US patients and surgeons seeking for a substitute to valve replacement for the conduct of aortic valve inadequacy.”

CEO and President, John Wheeler, said, “With the HAART 300 now accessible in Europe as well as the United States, BioStable can rotate our focus to finishing the compliances for the US and European authorization of our HAART 200 Aortic Annuloplasty equipment designed for the bicuspid aortic valve repair. Due to the technical obstacles and higher rates of recurring insufficiency often seen with accessible bicuspid aortic valve repair methods, there is a particularly pressing requirement for new annuloplasty techniques for bicuspid valve repair.”

We hope even the other device is successful in treating patients and receive a CE mark and FDA clearance. What is your opinion regarding the device for aortic valve repair?