BioStable Science & Engineering Initiates European Commercialization of the HAART™ 300 Aortic Annuloplasty Device
First commercial implantation performed by Dr. Domenico Mazzitelli, at the German Heart Center Munich
Austin, TX – May 16, 2016 – BioStable Science & Engineering, Inc. announced today that the first commercial implantation of its HAART 300 Aortic Annuloplasty Device was performed by Dr. Domenico Mazzitelli on Wednesday May 11th at the German Heart Center Munich. Additional procedures were completed on Friday May 13th by Professor Yeong-Hoon Choi at the University of Cologne Heart Center. These two respected heart centers were the first selected to receive the HAART 300 Aortic Annuloplasty Device as part of the limited commercial launch of the technology announced by the company in March.
Dr. Mazzitelli, who served as the lead clinical investigator for the European clinical trials, commented “German Heart Center Munich is committed to offering our patients the latest technological innovations in heart surgery. Aortic valve repair offers patients an alternative to valve replacement that does not require long-term anticoagulation therapy, may reduce the risk of valve related complications, and provides better long-term survival. Our experience during the clinical studies demonstrated the use of the HAART 300 Aortic Annuloplasty Device simplifies and standardizes aortic valve repair and we are excited to now have the technology available for our patients.”
The HAART 300 Aortic Annuloplasty Device is the first commercially available internal annuloplasty ring developed for the aortic valve. The device was designed to resize, reshape, and stabilize the aortic valve annulus in patients undergoing valve repair for aortic insufficiency. BioStable conducted a two-year, regulated CE Mark approval study of the HAART 300 Aortic Annuloplasty Device at eight European heart centers. The 2-year clinical outcomes in the subgroup of patients with aortic root or ascending aortic aneurisms will be presented on Wednesday, May 18th, by Dr. Mazzitelli at the 96th Annual Meeting of the American Association for Thoracic Surgery in Baltimore, Maryland.
Concurrent with the European launch, BioStable announced the hiring of Regina Burnett as the new Vice President of Sales. Mrs. Burnett is the former Vice President of International Sales for On-X Life Technologies and brings more than 18 years of global heart valve sales management experience to BioStable. Regarding her new role, Mrs. Burnett said, “Annuloplasty devices are the technology that enabled valve repair to become the standard of care for mitral and tricuspid valve insufficiency. BioStable is the first company to successfully develop an internal annuloplasty device for the complex anatomy of the aortic valve. The HAART 300 Aortic Annuloplasty Device helps to fill a significant gap in the treatment options available to patients and I am extremely pleased to have the opportunity to help BioStable introduce this important technology to surgeons throughout Europe.”
John Wheeler, President and CEO, concluded by saying, “BioStable is very pleased to initiate commercialization of the HAART 300 Aortic Annuloplasty Device in Europe. The addition of Mrs. Burnett to our management team strengthens our ability to execute our limited European launch strategy while we continue to work towards U.S. FDA approval. We look forward to training additional heart centers in the coming months.”
About BioStable Science & Engineering
BioStable Science & Engineering is a cardiovascular device company focused on developing and commercializing proprietary valve repair technologies that provide an alternative to valve replacement for patients with aortic valve disease. The company’s HAART Aortic Repair Technologies are designed to simplify and standardize aortic valve repair, enabling surgeons to offer the recognized clinical benefits of valve repair to patients undergoing surgical correction of aortic insufficiency or aortic root aneurysm.
President & CEO