FDA Approves ATS’ AP360 Mechanical Heart Valve

The latest addition to ATS Medical’s suite of mechanical heart valve offerings, the AP360, has been approved for use in the U.S. The new design employs a supra-annular cuff that facilitates implantation and may appeal to a broader range of surgeons.

Michael Dale, President and CEO of ATS commented, “Heart valve sewing cuff material and design contribute to the ease with which suturing needles pass through the cuff and an uncomplicated positioning of the valve at the implant site. Surgeons develop a feel for, and gain confidence and comfort in a cuff that is well suited to their individual surgical techniques. When it comes to sewing cuffs, one style does not fit all tastes.”

In an interview with OneMedPlace this summer, Dale had indicated that a key growth driver would be the commercialization of its line of heart valves within the U.S.

“Because the market for mechanical heart valves remains highly competitive and continues to contract in size based on expanding indications for tissue heart valves, we have focused on increasing our product offering to existing customers.

Because our entire line is not available in the U.S., we believe the most efficient way to achieve this is to secure approval to commercialize all of these products domestically. Based on our work over the last two years, we expect to receive additional approvals in 2007.”

In August, the company received FDA clearance for additional sizes of its line of ATS Open Pivot mitral valves; clearance for its Simulus Semi-Rigid Annuloplasty Ring occurred in November.

In addition to a greater variety of indications for its mechanical heart valve within the U.S., ATS hopes to improve the profitability of its business internationally. ATS enjoys more than 15% procedure share in mechanical heart valves on a global basis, though the sales account for just 10% of revenue share as the majority of international sales occur through independent distributors. The company has been working with its international business partners to change the business model and close this gap.

In October 2006, ATS completed a $58 million purchase of 3F Therapeutics, a privately held developer of tissue heart valve products.  This acquisition opened the door to the $600 million tissue valve market and brought less-invasive surgical technology to ATS. In November, the company announced that a total of 47 patients have undergone aortic valve replacement with the ATS 3f Enable Aortic Bioprosthesis – designed to eliminate the traditional suturing needed to replace a diseased aortic heart valve.

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