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, Texas-based company.
“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. Wei said in a press release.
“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,” Dr. Badhwar said in a prepared statement.
The Haart 300 is designed as 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. The device won CE Mark approval in the European Union in 2016 and FDA 510(k) clearance in March.
The company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, and said that after implantation the device “serves as a framework for completing the overall repair procedure to maintain the patient’s native valve.”
“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,” prez & CEO John Wheeler said in a prepared release.