/Press Release

HAART 200 First Commercial Use

BioStable Science & Engineering Announces the First Commercial Use of the HAART 200™ Aortic Annuloplasty Device Austin, TX – September 26, 2017 - BioStable Science & Engineering, Inc. announced today the first commercial use of the HAART 200 Aortic Annuloplasty Device in the U.S. by doctors at the West Virginia University (WVU) Heart and Vascular Institute in Morgantown, West Virginia. Drs. Lawrence Wei, Vinay Badhwar and J. Scott Rankin were the collaborating surgeons for the [...]

2018-11-12T17:56:30+00:00September 26th, 2017|Press Release|

HAART 200 Receives FDA Clearance

BioStable Science & Engineering Announces FDA Clearance of the HAART™ 200 Aortic Annuloplasty Device for Bicuspid Aortic Valve Repair Austin, TX – August 15, 2017 - BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 200 Aortic Annuloplasty Device, the first and only annuloplasty device designed specifically for bicuspid aortic valve repair. With FDA clearance of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable is [...]

2018-11-12T17:56:38+00:00August 15th, 2017|Press Release|

First Commercial Use of the HAART 300 in US

BioStable Science & Engineering Announces U.S. Pilot Launch and First Commercial Use of the HAART™ 300 Aortic Annuloplasty Device - HAART 300 Aortic Annuloplasty Device, announced today the first commercial uses of the HAART 300 Aortic Annuloplasty Device in the U.S. by doctors at the West Virginia University (WVU) Heart and Vascular Institute in Morgantown, West Virginia. Dr. Lawrence Wei, Dr. Vinay Badhwar and Dr. J. Scott Rankin, were the collaborating surgeons for the procedures.

2018-11-12T19:04:24+00:00June 14th, 2017|Press Release|

HAART 300 Receives FDA Clearance

BioStable Science & Engineering announces FDA clearance of the HAART™ 300 Aortic Annuloplasty Device Austin, TX – March 22, 2017 - BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. BioStable expects the HAART 300 Aortic Annuloplasty Device to be available to select U.S. heart centers in the summer of 2017. BioStable [...]

2018-11-12T17:57:07+00:00March 22nd, 2017|Press Release|

BioStable De Novo Application to FDA for the HAART 300

BioStable Science & Engineering Completes Direct De Novo Application to FDA for the HAART™ 300 Aortic Annuloplasty Device Austin, TX – October 11, 2016 - BioStable Science & Engineering, Inc. announced today that it has completed a direct de novo application to the U.S. Food and Drug Administration (FDA) for Class II designation of the HAART 300 Aortic Annuloplasty Device. Submission of the de novo request is an important milestone in BioStable’s efforts to bring [...]

2018-11-12T17:57:53+00:00October 11th, 2016|Press Release|