BioStable Science & Engineering Initiates European Commercialization of HAART ™ 200 Aortic Annuloplasty Device | business

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AUSTIN, Texas – (BUSINESS WIRE) – Nov. August 2021–

BioStable Science & Engineering, Inc. announced today that the first commercial implants of its HAART 200 aortic annuloplasty device were performed on Monday August 2nd by Professor Marek Jasinski, Chief Physician of Cardiac Surgery at Wroclaw Medical University (Wroclaw, Poland). Further interventions were completed on Thursday, August 5th, by Professor Marek Deja, Chief Physician of Cardiac Surgery at the Silesian Medical University (Katowice, Poland). These two prestigious heart centers were the first to receive the HAART 200 aortic annuloplasty device as part of the limited European 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 and offers a new option for the most common congenital heart defect, bicuspid aortic valve disease. Our experience with the HAART 300 aortic annuloplasty devices for trileaflet aortic valve repair has shown us how the devices simplify aortic valve repair while providing permanent annuloplasty. This enables us to extend the benefits of valve repair to more patients. Availability of the HAART 200 device is critical as patients with bicuspid aortic valve disease are younger, which multiplies the benefits of valve repair over replacement. “

Although convincing long-term clinical data suggest that almost all bicuspid aortic valves should be repaired[1], current repair techniques are complex and not widely used. The HAART 200 device simplifies the repair of the bicuspid aortic valve by stabilizing the annulus and reshaping the valve in a symmetrical 180-degree orientation of the leaflet, eliminating the need for extensive dissection of the aortic root and making it easier to repair the leaflet.

John Wheeler, President and CEO concluded, “BioStable is excited to begin commercializing the HAART 200 aortic annuloplasty device in addition to the HAART 300 devices. With the commercial availability of the HAART 200 and HAART 300 aortic annuloplasty devices, BioStable can offer surgeons in Europe a comprehensive portfolio of aortic valve repair solutions that address all forms of aortic regurgitation. “

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 so that surgeons can offer the recognized clinical benefits of valve repair to patients undergoing surgical correction of aortic regurgitation or aneurysm. To learn more, visit www.biostable-se.com.

1. Miyahara S, Schneider U, Morgenthaler L, Schäfers HJ. (Almost) all non-stenotic bicuspid aortic valves should be preserved or repaired. Semin Thorac Cardiovasc Surg. 2019 Winter; 31 (4): 656-660. doi: 10.1053 / j.semtcvs.2019.03.008. Epub 2019 April 10th. PMID: 30980934.

Show source version on businesswire.com:https://www.businesswire.com/news/home/20210806005095/en/

CONTACT: John Wheeler

President and CEO

[email protected]

512-386-1996

KEYWORD: EUROPE UNITED STATES POLAND NORTH AMERICA TEXAS

INDUSTRY KEYWORD: MEDICAL DEVICES HEALTH SURGERY GENERAL HEALTH CARDIOLOGY BIOTECHNOLOGY

SOURCE: BioStable Science & Engineering, Inc.

Copyright Business Wire 2021.

PUB: 6/8/2021 8:00 AM / DISC: 6/8/2021 8:02 AM

http://www.businesswire.com/news/home/20210806005095/en

Copyright Business Wire 2021.


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