Cardiovascular device developer BioStable Science & Engineering said today it completed a de novo application to the FDA as it seeks Class II designation for its Haart 300 aortic annuloplasty device.
The Austin, Texas-based company said its Haart 300 is an internal aortic annuloplasty ring designed to replicate the anatomy of the aortic valve and resize, reshape and stabilize the aortic annulus to restore valve competence and prevent recurrent aortic regurgitation.
BioStable Science & Engineering said that after implantation, its Haart 300 device “serves as a framework for completing the overall repair procedure to maintain the patient’s native valve.”
“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,” president & CEO John Wheeler said in a press release.
The company said it recently completed a multi-center clinical study of its Haart 200 aortic annuloplasty device designed for bicuspid valve repair, with plans to use results from the study to support CE Mark approval of the device in early 2017.
In March, BioStable Science & Engineering said it won CE Mark approval in the European Union for its HAART 300 aortic annuloplasty device designed for aortic valve repair.