On March 27 the company implanted its first ADAPT single-piece 3D aortic valve in a patient with aortic stenosis.
Professor Bart Meuris at the University Hospitals in Leuven, Belgium conducted the cardiac heart valve surgery.
“Pleased” with initial results
Professor Leon Neethling said: “The patient is doing well with normal gradients upon discharge and had an event free recovery.
“I am very pleased with the initial results.
“With our first patient who now has normal haemodynamics and an excellent EOA, I am looking forward to seeing more patients enter into the study in the coming weeks and months.”
Chief executive officer Wayne Paterson said: “We are very pleased with the patient’s recovery so far and will continue to keep the market updated as and when it’s appropriate as study progresses.”
US FDA clearance
Admedus has also announced the US FDA clearance of an indication change to its ADAPT® -treated (bovine pericardium) tissue through the Special 510(k) pathway.
The change extends ADAPT® tissue approval for use in cardiac defects including intracardiac defects, septal defects and valve and annulus repairs.
Paterson said: “This approval marks an important distinction from previous approvals and clears the way for future approvals of ADAPT based material for our aortic valve products.”