New Heart Valve Approved for U.S. Market
The Food and Drug Administration has approved use of the Open Pivot AP360, a new heart valve. The device is manufactured by ATS Medical, Incorporated. The company issued a press release with the news.
The OpenPivot AP360 mimics the natural pumping that is completed by a normal and healthy functioning natural heart valve. The device was created with a supra-annular cuff design, which facilitates normal hemodynamics.
The new valve is based on the existing valve available from ATS Medical, the OpenPivot. The new cuff design appeals to a broader range of cardiothoracic surgeons, according to the company.
Additional benefits of the device include the simplicity of device implantation. Suturing, for example, is made easier by the composite materials of the valve cuff. As well, incorporated features reduce the likelihood that patients will develop a clot. Previous data indicates that mechanical valves are associated with a higher risk of developing a blood clot.
The company already has a line of mechanical heart valves. The company cites the approval of the Open Pivot AP360 as an important expansion of that line, particularly in gaining the favor from surgeons who have generally used other devices for valve replacement but appreciated the original OpenPivot product.
December 26, 2007 Related topics: Product Approval & Certification, Cardiology