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 the potential benefits of valve repair to U.S. patients suffering with aortic valve insufficiency.
In patients with aortic insufficiency, dilatation of the valve annulus distorts the three-dimensional valve anatomy thereby reducing or preventing proper closure of the valve leaflets. Implantation of the HAART 300 Aortic Annuloplasty Device is designed to conform the aortic annulus to the three-dimensional shape of the device, thereby potentially restoring and maintaining more normal anatomical valve geometry for proper valve closure. Once implanted, the HAART 300 Device serves as a framework for completing the overall repair procedure to maintain the patient’s native valve. Aortic valve repair is a treatment approach that may offer patients substantial improvement in clinical symptoms while eliminating the need for lifelong anticoagulation therapy frequently required with many valve replacement technologies.1
With the receipt of the CE Mark announced in March of this year, the HAART 300 Aortic Annuloplasty Device became the first commercially available internal annuloplasty device developed for aortic valve repair. A limited commercial launch was initiated in May in the EU, and a select number of European heart centers have already completed training and are incorporating the device within their valve repair programs.
The company also recently concluded the European multi-center clinical study of the HAART 200 Aortic Annuloplasty Device for bicuspid valve repair. Bicuspid valve disease is a congenital heart defect in which the aortic valve has only two functional valve leaflets instead of the normal three. The condition affects approximately 2.0% of the population and is frequently associated with aortic aneurysms and aortic insufficiency. Aortic valve repair is a particularly attractive option for these patients because surgical intervention is typically required at the very young average age of 40.2 The 2-year outcomes from the HAART 200 study will be used to support an application for CE mark in early 2017.
Commenting on the company’s recent accomplishments, John Wheeler, BioStable’s President and CEO, said “The HAART Aortic Repair Technologies are design to make surgical repair of the aortic valve a simpler and more standardized procedure. Submission of the HAART 300 de novo application and completion of the HAART 200 clinical study are important achievements towards BioStable’s goal of expanding the availability of our HAART Aortic Repair Technologies for surgeons and patients.”
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. To learn more visit www.biostable-s-e.com.
The HAART Aortic Annuloplasty Devices are investigational devices in the United States and are not available for sale.
1 de Meester C, Pasquet A, Gerber BL, et al. Valve repair improves the outcome of surgery for chronic severe aortic regurgitation: A propensity score analysis. J Thorac Cardiovasc Surg. 2014 Nov;148(5):1913-20.
2 Siu SC, Silversides CK. Bicuspid aortic valve disease. J AM Coll Cardiol. 2010;55:2789-800.
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Last updated on: 11/10/2016
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