Cardiovascular device company BioStable Science & Engineering is seeking approval from the US Food and Drug Administration (FDA) for its HAART 300 aortic annuloplasty device.
The company completed a direct de novo application to the FDA for class II designation of the aortic annuloplasty device.
The HAART 300 has been designed to adjust the aortic annulus to the three-dimensional shape of the device, helping to restore and maintain normal anatomical valve geometry for proper valve closure.
Once implanted, the device acts as a framework to complete overall repair procedure to maintain the native valve of the patient.
In March this year, the company secured CE mark approval for HAART 300 aortic annuloplasty device.
In May, the firm initiated a limited commercial release of the system in the European Union (EU) region.
Recently, the company has completed European multi-center clinical study of the HAART 200 device for bicuspid valve repair.
According to the company, the bicuspid valve disease is a congenital heart defect in which the aortic valve has only two functional valve leaflets instead of the normal three.
BioStable Science & Engineering president and CEO John Wheeler said: said “The HAART Aortic Repair Technologies are design to make surgical repair of the aortic valve a simpler and more standardized procedure.
“Submission of the HAART 300 de novo application and completion of the HAART 200 clinical study are important achievements towards BioStable’s goal of expanding the availability of our HAART Aortic Repair Technologies for surgeons and patients.”
The company is engaged in the development and commercialization of proprietary valve repair technologies to treat patients with aortic valve disease.