BIOSTABLE Science & Engineering

Simplifying and Standardizing Aortic Valve Repair

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.

Read more about our company, management and mission.

BioStable products

Aortic Valve Disease

“Aortic valve insufficiency is the most common valvular heart disease, affecting more than 2.5 million adults world-wide.”
[Read more]

Valve Repair vs Replacement

“Valve repair is more durable than biological valve replacement and avoids the complications associated with anticoagulation medications required with mechanical valve replacement.”
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HAART Aortic Repair Technologies

Resize the aortic valve annulus to reduce dilatation, Reshape the aortic valve to restore more normal, three-dimensional coaptation geometry, Stabilize the aortic valve to reduce the risk of recurrent annular dilatation.

Read more about the HAART 300 Annuloplasty Device

HAART 300 Aortic Annuloplasty Device

The HAART 300 Aortic Annuloplasty Device was designed from mathematical reconstructions of high resolution, computed tomographic angiogram (CTA) images of normal aortic valves.

HAART 200 Aortic Annuloplasty Device

The HAART 200 Aortic Annuloplasty Device has been designed specifically for use during the repair of bicuspid aortic valves.

(The HAART 200 Aortic Annuloplasty Device is an investigational device and not available for sale.)

Read more about Standardized Annuloplasty Technique

Standardized Annuloplasty Technique

Correct device sizing is determined from leaflet free-edge lengths to restore appropriate annular dimensions and commissure positioning for the patient’s individual leaflet anatomy.

Read more about Aortic Root Restoration

Aortic Root
Restoration

Valve Sparing Root Replacement Simplified. – Aortic root remodeling plus annuloplasty with the HAART Aortic Annuloplasty Device simplifies valve repair and eliminates root dissection.

News and Events

Event — Boston, MA – April  29 – May 3, 2017
AATS Centennial – 100th Anniversary of the American Association for Thoracic Surgeons. Visit us at Booth No. 834 … [Read for more information]

Event — Leipzig, Germany – February 11 – 14, 2017
Heart Medicine 2017 – 46th Annual Meeting of the German Society for Thoracic, Cardiac and Vascular Surgery. Visit us at Booth No. C.11 …
[Read for more information]

Press Release — Austin, TX – March 22, 2017 — BioStable Science & Engineering announces FDA clearance for the HAART 300 Aortic Annuloplasty Device

BioStable expects the HAART 300 Aortic Annuloplasty Device to be available to select U.S. heart centers …
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Press Release — Austin, TX – Oct 11, 2016 — BioStable Science & Engineering Completes Direct De Novo Application to FDA for 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 … [Read more]

Press Release — Austin, TX – May 16, 2016 — BioStable Science & Engineering Initiates European Commercialization of the HAART™ 300 Aortic Annuloplasty Device

First commercial implantation performed by Dr. Domenico Mazzitelli, at the German Heart Center Munich … [Read more]