Investigator: Jan Champion (Edwards Lifesciences)

IDE: n/a

FDA approval: Yes

CE mark: Yes

Recruitment status: Active, not recruiting

Phase: Post market

Study type: Interventional

Study design: Safety/Efficacy – single group

Primary outcome measures: Mean effective orifice area at 1 year post implant

Time frame – Primary outcome: 5 years

Target enrolment: 20 pts.

Start date: March 2011

Estimated primary completion date: December 2017

Estimated completion date: December 2017

Age (years): >13

Gender: Both

Last update: January 2017

More info: [Editorial content goes here]

Edwards Lifesciences has announced long-term durability results for bovine pericardial heart valves, based on a study of the Carpentier-Edwards Perimount Aortic valve, in a subset of patients aged 60 or younger at the time of operation. Post market clinical studies on 3,299 patients have found that the expected valve durability for this population was greater than 17 years. The data were presented at the Congress of the French Society for Thoracic and Cardiovascular Surgery by Thierry Bourguignon, from University Hospital of Tours, France.
The valve, which was introduced into clinical use in 1981, is bioengineered with precisely-matched leaflets made from bovine pericardial tissue that are handsewn onto a stainless steel frame. The design of the valve, including its frame and leaflets, serves as the model for Edwards’ leading surgical products (Magna Ease and Magna Mitral Ease) are based.