AUSTIN, Texas--(BUSINESS WIRE)--BioStable Science & Engineering, a medical technology company focused on products for aortic valve repair for the treatment of aortic insufficiency, today announced that over 500 patients worldwide have now been treated using the HAART Aortic Annuloplasty Device.
“Many cardiothoracic surgeons recognize that the young aortic insufficiency patient population cannot be treated with percutaneous aortic valve replacement devices and should be treated surgically with aortic valve repair whenever possible.1 The HAART Aortic Annuloplasty Devices are enabling surgeons to perform successful aortic valve repair across a broad spectrum of this underserved patient population,” says John Wheeler, President and CEO of BioStable Science & Engineering.
While patients have benefited from advances in mitral valve repair procedures for decades, reproducing the same positive results ─ long-term durability, freedom from re-operation and normal life expectancy ─ using aortic valve repair techniques has been challenging. The HAART family of products received clearance from the U.S. Food & Drug Administration in 2017 and provides an attractive surgical solution for patients suffering from aortic valve regurgitation. To date, over 50 heart centers have adopted the HAART technology including five new hospitals in April alone performing their first HAART implant.
“Aortic valve repair has only been provided to a fraction of aortic insufficiency patients. The HAART technologies offer surgeons the means to standardize and simplify the approach to aortic valve repair for consistent, effective outcomes and the opportunity to avoid valve replacement for many more patients,” said Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Heart Center, Marc W. Gerdisch, MD. “We have used the HAART devices in more than two dozen patients, and they have performed exceptionally."
"As surgeons experience the versatility of our approach, they are becoming increasingly confident using our devices in lieu of alternative aortic repair or replacement methods. We believe increasing awareness of the potential benefits of early surgical intervention in patients with severe aortic insufficiency2 combined with the growing positive experience with our HAART Technologies will drive a shift towards wider adoption of aortic valve repair,” said Wheeler. "We are excited about our prospects for accelerating adoption of our technologies."
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 aneurysm. To learn more visit www.biostable-s-e.com.
- Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791.
- Yang LT, Michelena HI, Scott CG. et al. Outcomes in Chronic Hemodynamically Significant Aortic Regurgitation and Limitations of Current Guidelines. J Am Coll Cardiol. 2019 Apr 16;73(14):1741-1752.