ATS Medical announced Australian regulatory approval for ATS 3f Aortic Bioprosthesis

ATS Medical, Inc.,  manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for commercialization of the ATS 3f(R) Aortic Bioprosthesis.

ATS Medical, Inc.,  manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for commercialization of the ATS 3f(R) Aortic Bioprosthesis.

Based on the precept that 'Form Follows Function', the ATS 3f Aortic Bioprosthesis is a revolutionary next generation stentless pericardial aortic tissue valve that is unlike any other valve. The primary benefit of the ATS 3f Aortic Bioprosthesis is its tubular design that restores continuity between the annulus and the sinotubular junction.

By restoring this continuity, the ATS 3f Aortic Bioprosthesis is the only aortic valve that preserves the aortic sinuses and restores native valve stress distribution and physiologic blood flow. This valve design provides surgeons and patients with a potentially more durable solution to aortic valve replacement.

With more than six years of clinical experience confirming excellent safety and efficacy, the demonstrated clinical benefit and recent FDA approval of the ATS 3f Aortic Bioprosthesis are creating excitement and product demand among US surgeons.