Bicuspid Aortic Valve Disease

First commercial implantations of the HAART 200 Device for Bicuspid Aortic Valve repair performed by Professor Marek Jasinski at the Wroclaw Medical University BioStable Science & Engineering Initiates European Commercialisation of the HAART 200 Aortic Annuloplasty Device. (Credit: Raman Oza from Pixabay) BioStable Science & Engineering, Inc. announced today that the first commercial implantations of its HAART 200 Aortic Annuloplasty Device were performed on Monday, August 2nd by Professor Marek Jasinski, Chief of Cardiac Surgery at Wroclaw Medical University (Wroclaw, Poland). Additional procedures were completed on Thursday, August 5th by Professor Marek Deja, Chief of Cardiac Surgery at the Medical University of Silesia (Katowice, Poland). These two respected heart centers were the first selected to receive the HAART 200 Aortic Annuloplasty Device as part of the limited European commercial launch of the technology announced by the company in April. Professor Jasinski commented, “The HAART 200 Aortic Annuloplasty Device is a great addition to our aortic valve repair tool kit providing a new option for the most common congenital heart defect, bicuspid aortic valve disease. Our experience with the HAART 300 Aortic Annuloplasty Devices in trileaflet aortic valve repair has shown us how the devices simplify aortic valve repair and at the same time provide durable annuloplasty. This allows us to expand the benefits of valve repair to more patients. The availability of the HAART 200 Device is critically important because patients with bicuspid aortic valve disease are younger, multiplying the benefits of valve repair vs. replacement.” Although compelling long-term clinical data suggest that almost all bicuspid aortic valves should be repaired[1], current repair techniques are complex and not widely adopted. The HAART 200 Device simplifies bicuspid aortic valve repair by stabilizing the annulus and remodeling the valve into a symmetric, 180-degree leaflet orientation, eliminating the need for extensive dissection of the aortic root, and facilitating leaflet repair. John Wheeler, President and CEO, concluded by saying, “BioStable is very pleased to initiate commercialization of the HAART 200 Aortic Annuloplasty Device alongside the HAART 300 Devices. With the commercial availability of the HAART 200 and HAART 300 Aortic Annuloplasty Devices, BioStable can offer surgeons within the European a comprehensive portfolio of aortic valve repair solutions that addresses all forms of aortic valve insufficiency.” Source: Company Press Release

BioStable Science & Engineering is a cardiovascular device company focused on proprietary valve repair technologies BioStable Science & Engineering gets CE Mark approval for the HAART 200 Aortic Annuloplasty Device. (Credit: Ignacio DG from Pixabay.) BioStable Science & Engineering, Inc. (“BioStable”) announced today the company has received CE Mark approval for the HAART 200 Aortic Annuloplasty Device for use during bicuspid aortic valve repair. With CE Mark approval of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable will be able to offer surgeons within the European Union a comprehensive portfolio of aortic valve repair solutions that address all forms of aortic valve insufficiency. In addition, BioStable announced that over 1,000 patients worldwide have now been treated using HAART Aortic Annuloplasty Devices. Bicuspid aortic valve (BAV) is the most common congenital heart defect, affecting up to 2% of the population, and carries a significant risk of cardiovascular complications. Approximately 53% of BAV patients require aortic valve surgery within 25 years of being diagnosed [1]. Most BAV patients undergo aortic valve replacement between 40 and 60 years of age, subjecting them to increased risk of reoperation or complications associated with valve replacement technologies [2]. Valve repair is an attractive alternative to valve replacement for bicuspid aortic valve insufficiency and the HAART 200 Device has been specifically designed to facilitate BAV repair. “People with BAV tend to present while still young. With many years of life still ahead, they are hoping to continue their normal active lifestyle, avoid life-long anticoagulation and the thromboembolic risk of a prosthetic valve that accrues for the rest of their lives. BAV repair offers freedom from these challenges, but the techniques to achieve success with varying subtypes have lacked standardization, leaving the majority of BAV insufficiency considered unrepairable and thus replaced. The HAART devices assign proper geometry to the valve and allow surgeons to apply a well standardized methodology to achieve excellent valve function. Over the last several years we have refined a set of techniques that are easily taught and reproduced,” said Chief of Cardiothoracic Surgery at Franciscan Health, Marc W. Gerdisch, MD. “Later this month, we will present on the experience from 15 institutions with 70 patients at the American Association for Thoracic Surgery Annual Meeting.” The body of published clinical evidence demonstrating the excellent outcomes achievable with the HAART devices has been rapidly increasing. To date, there are more than 38 peer-reviewed publications covering over 300 patient lives with a maximal follow-up of 88 months. This collection of clinical information comes from over 30 institutions across the US and Europe. “The latest mid-term follow-up data are compelling and suggest good durability of aortic valve repair with the HAART devices. The latest HAART data demonstrates >80% of patients are alive and free from reoperation at a maximal follow-up of 88 months, similar to other repair strategies [3]. The difference is that, with the HAART system, it is possible to repair over 90% of non-calcified AI pathologies [4],” said Dr. J. Scott Rankin, Professor of Surgery at West Virginia University Heart and Vascular Institute, and inventor of the HAART Aortic Repair Technologies. John Wheeler, President, and CEO of BioStable Science & Engineering, concluded by saying: “The CE Mark approval for the HAART 200 Aortic Annuloplasty Device completes the HAART portfolio in Europe and allows surgeons to now address all types of aortic valve configurations with AI. The combination of this approval with the growing positive clinical evidence indicates the value that aortic ring annuloplasty provides to surgeons and patients. We expect to perform our first cases with the HAART 200 Devices in EU in a targeted launch of the product later this year.” Source: Company Press Release

April 21, 2021 11:00 UTC AUSTIN, Texas--(BUSINESS WIRE)-- BioStable Science & Engineering, Inc. (“BioStable”) announced today the company has received CE Mark approval for the HAART 200 Aortic Annuloplasty Device for use during bicuspid aortic valve repair. With CE Mark approval of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable will be able to offer surgeons within the European Union a comprehensive portfolio of aortic valve repair solutions that address all forms of aortic valve insufficiency. In addition, BioStable announced that over 1,000 patients worldwide have now been treated using HAART Aortic Annuloplasty Devices. Bicuspid aortic valve (BAV) is the most common congenital heart defect, affecting up to 2% of the population, and carries a significant risk of cardiovascular complications. Approximately 53% of BAV patients require aortic valve surgery within 25 years of being diagnosed [1]. Most BAV patients undergo aortic valve replacement between 40 and 60 years of age, subjecting them to increased risk of reoperation or complications associated with valve replacement technologies [2]. Valve repair is an attractive alternative to valve replacement for bicuspid aortic valve insufficiency and the HAART 200 Device has been specifically designed to facilitate BAV repair. “People with BAV tend to present while still young. With many years of life still ahead, they are hoping to continue their normal active lifestyle, avoid life-long anticoagulation and the thromboembolic risk of a prosthetic valve that accrues for the rest of their lives. BAV repair offers freedom from these challenges, but the techniques to achieve success with varying subtypes have lacked standardization, leaving the majority of BAV insufficiency considered unrepairable and thus replaced. The HAART devices assign proper geometry to the valve and allow surgeons to apply a well standardized methodology to achieve excellent valve function. Over the last several years we have refined a set of techniques that are easily taught and reproduced,” said Chief of Cardiothoracic Surgery at Franciscan Health, Marc W. Gerdisch, MD. “Later this month, we will present on the experience from 15 institutions with 70 patients at the American Association for Thoracic Surgery Annual Meeting.” The body of published clinical evidence demonstrating the excellent outcomes achievable with the HAART devices has been rapidly increasing. To date, there are more than 38 peer-reviewed publications covering over 300 patient lives with a maximal follow-up of 88 months. This collection of clinical information comes from over 30 institutions across the US and Europe. “The latest mid-term follow-up data are compelling and suggest good durability of aortic valve repair with the HAART devices. The latest HAART data demonstrates >80% of patients are alive and free from reoperation at a maximal follow-up of 88 months, similar to other repair strategies [3]. The difference is that, with the HAART system, it is possible to repair over 90% of non-calcified AI pathologies [4],” said Dr. J. Scott Rankin, Professor of Surgery at West Virginia University Heart and Vascular Institute, and inventor of the HAART Aortic Repair Technologies. John Wheeler, President, and CEO of BioStable Science & Engineering, concluded by saying: “The CE Mark approval for the HAART 200 Aortic Annuloplasty Device completes the HAART portfolio in Europe and allows surgeons to now address all types of aortic valve configurations with AI. The combination of this approval with the growing positive clinical evidence indicates the value that aortic ring annuloplasty provides to surgeons and patients. We expect to perform our first cases with the HAART 200 Devices in EU in a targeted launch of the product later this year.” 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 . 1. Michelena HI, Khanna AD, Mahoney D, et al. Incidence of aortic complications in patients with bicuspid aortic valves. JAMA. 2011 Sep 14;306(10):1104-12. 2. Vallabhajosyula P, Szeto WY, Habertheuer A. et al. Bicuspid aortic insufficiency with aortic root aneurysm: root reimplantation versus Bentall root replacement. Ann Thoracic Surg 2016;102:1221-8. 3. Baker J, et al. Minimally Invasive Aortic Valve Repair using Geometric Ring Annuloplasty. The Society of Thoracic Surgeons Annual Meeting, January 29-31, 2021 4. Rankin JS, et al. Aortic Valve Repair Using Geometric Ring Annuloplasty. Operative Techniques in Thoracic and Cardiovascular Surgery. 2021