The CardioSculpt FIH study is a 30-patient prospective single-arm study evaluating the Valvuloplasty Scoring Balloon in patients with symptomatic critical
aortic valve stenosis who are not deemed to be candidates for trans-catheter or surgical valve replacement or as a bridge to these procedures.
Surgery to replace the aortic valve is an effective treatment for severe senile
aortic valve stenosis.
Aortic valve stenosis can be caused by a congenital abnormality, rheumatic fever and senile degenerative stenosis.
Symptoms of
aortic valve stenosis can include fatigue, dizziness, chest pain or pressure, heart murmur, shortness of breath during activity, heart palpitations and fainting.
The CE-mark trial is designed as a prospective multicentric uncontrolled study in which up to 70 patients with severe symptomatic
aortic valve stenosis will be enrolled.
We use the JenaValve transapical TAVI system on a very regular basis at the University Heart Center Hamburg for patients suffering from
aortic valve stenosis who are at too high risk for conventional surgery.
About Symptomatic Severe
Aortic Valve Stenosis Aortic stenosis is a condition of the aortic valve which prevents the valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body.
The CoreValve system, designed to treat severe
aortic valve stenosis without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 34 countries outside the United States.
Food and Drug Administration recently expanded the approved indication for the Edwards SAPIEN THV to include patients with
aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
eIuThousands of critically ill patients with severe
aortic valve stenosis are refused surgery every year, and the annual mortality rate is as high as 25 percent in this frail population,eIN said Prof.
This patient's pre-operative condition was substantially impaired due to significant
aortic valve stenosis and a severely calcified aorta," said Dr.
Chief of Cardiac Surgery at Sacre-Coeur Hospital in Montreal, Quebec, Canada, on a 68-year-old man who was diagnosed with
aortic valve stenosis (narrowing).
