St. Jude Medical Scores with the FDA on Valves with Anti-Calcification Technology

Newly approved Epic™ stented tissue valves from St. Jude Medical, Inc. are identical in design to the super popular Biocor™ valves, but they also feature Linx™ antimineralization technology.
From the press release:

Like the company’s Biocor Valve with the FlexFit™ Stent, the Epic Valve features the industry’s lowest overall valve height, enhancing implantability. In the mitral position, the valve’s low profile reduces the risk of obstructing blood flow into the aorta. In the aortic position, it may provide optimal coronary ostia clearance and reduce the risk of aortic wall protrusion. The new valve will be available in aortic [side image –ed.], aortic supra [upper image –ed.] and mitral models.

More about the anticalcification technology:

At the leading edge of heart valve technology, St. Jude Medical incorporates an innovative anticalcification process into the SJM Epic valve. Developed and patented by Robert Levy, MD, Linx technology works to provide a shield against calcification.
Research suggests that glutaraldehyde, calcium, and phospholipids play important roles in the calcification of bioprosthetic valves. Linx technology acts in multiple ways to combat the calcification process. This technology involves ethanol treatment of glutaraldehyde fixed valves. It has been shown extremely effective in preventing leaflet calcification in sheep mitral valve replacement models and rat subdermal studies.
Unlike any other current anticalcification technology, innovative Linx technology is believed to have multiple effects on cusp tissue, providing a powerful shield against valve mineralization. The action of Linx technology:

Reduces glutaraldehyde toxicity associated with calcification

Removes 99% of the cholesterol and 94% of the phospholipids, which are potential binding sites associated with tissue calcification

Greatly reduces the subsequent uptake of lipids in vitro

Results in stable changes to the collagen triple helix, as evidenced through infrared spectroscopy

Product page: SJM Epic™ Valve …
Linx™ Technology …
Press release: St. Jude Medical Announces FDA Approval of Epic Stented Tissue Valve with Anti-Calcification Technology …