Cardiovascular device developer BioStable Science & Engineering said today it won FDA clearance for its Haart 200 aortic annuloplasty device, touting it as the 1st and only such device designed specifically for bicuspid aortic valve repairs. The Austin, Texas-based company’s Haart 200 aortic annuloplasty device is intended for valve repairs in patients with aortic valve insufficiency […]
BioStable Science & Engineering
BioStable Science & Engineering begins limited release of Haart 300 annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said today it began a limited launch of its HAART 300 aortic annuloplasty device, with the 1st commercial procedure being performed at the West Virginia University Heart and Vascular Institute. The 1st procedure was performed by Dr. Lawrence Wei, Dr. Vinay Badhwar and Dr. J. Rankin, according to the Austin, […]
BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, expected to be available to select US heart centers this summer. “We are very grateful for […]
BioStable Science & Engineering seeks FDA de novo indication for Haart 300 annuloplasty device
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 […]
BioStable Science & Engineering wins CE Mark for annuloplasty device
Cardiovascular device company BioStable Science & Engineering said today it won CE Mark approval in the European Union for its HAART 300 aortic annuloplasty device designed for aortic valve repair. 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, […]
