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BioStable Science & Engineering Announces U.S. Pilot Launch and First Commercial Use of the HAART 300 Aortic Annuloplasty Device

June 14, 2017

BioStable Science & Engineering, Inc. 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.

Drs. Lawrence Wei, Vinay Badhwar and J. Scott Rankin of the WVU Heart and Vascular Institute were the collaborating surgeons for the procedures. The WVU Heart and Vascular Institute is the first of a select group of leading U.S. centers expected to participate in the limited launch of the HAART 300 device this year.

Commenting on his experience, Dr. Wei, co-director of the WVU Center for Aortic Surgery said, ”the novel sizing method and simple, quick implantation technique for the HAART 300 Aortic Annuloplasty Device help to standardize the overall repair procedure. Internal annuloplasty has significant advantages over existing aortic valve repair techniques and makes aortic valve repair a more attractive treatment option for a broader group of patients.”

Dr. Vinay Badhwar, Executive Chair of the WVU Heart and Vascular Institute, added, “Our surgeons are committed to offering patients the latest medical technologies that have the potential to improve patient outcomes. We believe the HAART Aortic Annuloplasty Device fills a significant technological need that helps make aortic valve repair a simpler and more reproducible procedure to the benefit of patients.”

In March of this year, HAART 300 became the first aortic annuloplasty device to receive clearance from the U.S. Food and Drug Administration. Annuloplasty devices are an essential component of successful mitral and tricuspid valve repair and BioStable Science & Engineering is the first company to develop annuloplasty device technologies for aortic valve repair. BioStable’s second technology offering, the HAART 200 Aortic Annuloplasty Device for bicuspid aortic valve repair, is currently under regulatory review both in Europe and the U.S.

John Wheeler, President & CEO, concluded by saying, “BioStable is excited to announce our initial launch of the HAART 300 in the U.S. The high level of surgeon interest in our HAART Aortic Repair Technologies has been very encouraging and we look forward to expanding our training to surgeons at additional U.S. heart centers in the coming months.”

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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