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aortic valve replacement icd 10
AUSTIN, Texas--(BUSINESS WIRE)--BioStable Science & Engineering, Inc. appear today it has accustomed FDA bazaar approval for the HAART 200 Aortic Annuloplasty Device, the aboriginal and alone annuloplasty accessory advised accurately for bicuspid aortic valve repair. With FDA approval of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable is now able to action U.S. surgeons a absolute portfolio of aortic valve adjustment solutions that addresses all forms of aortic valve insufficiency.
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A Bicuspid aortic valve (BAV) is a complete aberancy area the aortic valve forms with alone two anatomic valve leaflets instead of the accustomed three. BAV is the best accepted complete affection defect, affecting up to 2% of the population, and carries cogent accident of cardiovascular complications. Patients with BAV accept decidedly college accident of developing aneurysms or dissections of the aorta and about 53% of patients will crave aortic valve backup aural 25 years of actuality diagnosed.1 Best BAV patients abide aortic valve backup amid 40 and 60 years of age, subjecting them to added accident of reoperation or complications associated with valve backup technologies. Aortic valve adjustment is an arising surgical another for patients with bicuspid aortic valve dearth that may action bigger accommodating outcomes compared to valve replacement.2
The HAART 200 Aortic Annuloplasty Accessory is advised to facilitate valve adjustment in patients with aortic valve dearth due to BAV. The accessory is advised to abate annular bore based aloft advertisement size, to accommodate the annulus to a circular, symmetric appearance for bigger valve function, and to balance the annular geometry long-term.
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“Surgical adjustment of the bicuspid aortic valve can be a circuitous three dimensional botheration because of airheadedness in the valve anatomy,” explained Dr. J. Scott Rankin, Professor of Surgery at West Virginia University Affection and Vascular Institute, and artist of the HAART Aortic Adjustment Technologies. “Implantation of the HAART 200 Aortic Annuloplasty Accessory conforms the built-in valve to the three dimensional appearance of the device, creating a annular valve geometry and adjustment the advertisement commissures into the adopted 180 amount orientation. Conforming the built-in valve to this appearance simplifies appraisal and about-face of the valve leaflets and creates a axial breeze arrangement of claret through the valve which may advance the abiding backbone of the repair.”
John Wheeler, President and CEO of BioStable Science & Engineering, assured by saying, “Valve adjustment is an abnormally adorable another for the adolescent citizenry of patients acute surgical action for BAV disease. HAART 200 is abnormally advised to abode the specific abstruse challenges of BAV adjustment and BioStable is acutely admiring to add this artefact to our portfolio of valve adjustment solutions in the United States. We apprehend to accomplish our aboriginal cases in the U.S. in a targeted barrage of the artefact this fall.”
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About BioStable Science & Engineering
BioStable Science & Engineering is a cardiovascular accessory aggregation focused on developing and commercializing proprietary valve adjustment technologies that accommodate an another to valve backup for patients with aortic valve disease. The company’s HAART Aortic Adjustment Technologies are advised to abridge and assimilate aortic valve repair, enabling surgeons to action the accustomed analytic allowances of valve adjustment to patients ability surgical alteration of aortic dearth or aortic basis aneurysm. To apprentice added appointment www.biostable-s-e.com.
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The HAART 200 Aortic Annuloplasty Accessory is not accessible for auction alfresco of the United States.
1 Michelena HI1, Khanna AD, Mahoney D, et al. Incidence of aortic complications in patients with bicuspid aortic valves. JAMA. 2011 Sep 14;306(10):1104-12.
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2 Vallabhajosyula P, Szeto WY, Habertheuer A. et al. Bicuspid aortic dearth with aortic basis aneurysm: basis reimplantation against Bentall basis replacement. Ann Thoracic Surg 2016;102:1221-8.
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