Mansfield Scientific, Inc.

John P Ariola, Jr

Brice Letac

Alain Cribier

Dilatation procedures and catheter instrument for treating patients having acquired aortic stenosis, typically in which there are calcific deposits on the leaflets of the aortic valve. A dilatation balloon introduced into the stenosed aortic valve via the aorta while the blood circulation of the patient is maintained by the heart via the aortic valve, is inflated to grossly deflect the leaflets of the valve in a manner avoiding blocking the outer portions of the commissures of the valve. This inflating step enables substantial flow of blood through the outer portions of the commissures during systole despite the presence in the valve of the large inflated balloon. By prolonging the inflation for at least 30 seconds, over a large multiplicity of heart beats the calcific deposits are disturbed to increase the pliability of the leaflets and the degree of their opening, in an action found not to produce emboli. The catheter instrument incorporates means for measuring the pressure gradient across the valve and has features facilitating introduction, retention of position during inflation, withdrawal and re-crossing of the valve to achieve progressive enlargement of the aortic valve.

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East Providence, RI, United States of America

John P Ariola, Jr