DJM 18
Well-known member
I have been tracking this space and this seems to be an interesting development in the realm of Bicuspid Valve Repair. It is being done repeatedly at highly specialized centers with very good results. Cleveland clinic recently said that they have achieved in BAV 91% freedom from reoperation at 10 years; granted patient selection is an important factor in these numbers. Through time these centers have gained significant experience and modified procedures in a systematic format. I would hope that through a device such as this one it means that the procedure can be adopted much more widely, serving the needs of more and more young / healthy BAV patients that could consider a VSARR. In summary, it would be great if a device such as this one facilitates a very complicated procedure to some degree so that more and more surgeons around the world can make this operation part of their surgery arsenal. BioStable Science & Engineering wins FDA nod for Haart 200 aortic annuloplasty device BioStable Science & Engineering Cardiovascular device developer BioStable Science & Engineering said today it won FDA clearance for its Haart 200 aortic annuloplasty device, touting it as the 1st and only such device designed specifically for bicuspid aortic valve repairs. The Austin, Texas-based company’s Haart 200 aortic annuloplasty device is intended for valve repairs in patients with aortic valve insufficiency due to the congenital bicuspid aortic valve malformation in which the aortic valve forms with only 2 functional valve leaflets instead of 3. Bicuspid aortic valve malformations affect up to 2% of the population and carry a significant risk of cardiovascular complications, including higher risk of developing aneurysms or dissections of the aorta, with approximately 53% of patients requiring aortic valve replacements within 25 years of being diagnosed. “Surgical repair of the bicuspid aortic valve can be a complex 3 dimensional problem because of variability in the valve anatomy. Implantation of the HAART 200 Aortic Annuloplasty Device conforms the native valve to the three dimensional shape of the device, creating a circular valve geometry and aligning the leaflet commissures into the preferred 180 degree orientation. Conforming the native valve to this shape simplifies assessment and reconstruction of the valve leaflets and creates a central flow pattern of blood through the valve which may improve the long-term durability of the repair,” Haart aortic reapir tech inventor Dr. J. Rankin of the West Virginia University Heart and Vascular Institute said in a prepared statement. The device is designed to reduce annular diameter based upon leaflet size to conform the annulus to a circular, symmetric shape to improve valve function and stabilize annular geometry, the company said. “Valve repair is an especially attractive alternative for the young population of patients requiring surgical intervention for BAV disease. HAART 200 is uniquely designed to address the specific technical challenges of BAV repair and BioStable is extremely pleased to add this product to our portfolio of valve repair solutions in the United States. We expect to perform our first cases in the U.S. in a targeted launch of the product this fall,” prez & CEO John Wheeler said in a prepared release. In June, BioStable said 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 company.
