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CarboMedics announces first implant of unique new PhotoFix(TM) a Bioprosthesis.


AUSTIN, Texas--(BUSINESS WIRE)--Jan. 6, 1995--CarboMedics, a leading manufacturer of replacement heart valves Heart valves
Valves that regulate blood flow into and out of the heart chambers.

Mentioned in: Heart Failure
, announces the first implant on Dec. 15, 1994 of a revolutionary new bioprosthesis called the PhotoFix a Bioprosthesis at a leading cardiac center in western Europe. The recipient was a 67-year-old male who was suffering from aortic stenosis aortic stenosis
n. Abbr. AS
Pathological narrowing of the orifice of the aortic valve.


Aortic stenosis
A stiffening of the artery which carries blood from the heart to the body.
 and insufficiency. The implantation of the PhotoFix a Bioprosthesis was routine and the patient is doing fine.

The PhotoFix a Bioprosthesis is a trileaflet, central-flow prosthesis prosthesis (prŏs`thĭsĭs): see artificial limb.
prosthesis

Artificial substitute for a missing part of the body, usually an arm or leg.
 intended for use as a replacement for a diseased human cardiac aortic valve. The leaflets are made from bovine pericardial pericardial /peri·car·di·al/ (-kahr´de-al)
1. pertaining to the pericardium.

2. surrounding the heart.


pericardial

pertaining to the pericardium.
 tissue treated with a unique new patented fixation method (The PhotoFix(TM) process) and mounted on a flexible support frame. The valve is sterilized ster·il·ize  
tr.v. ster·il·ized, ster·il·iz·ing, ster·il·iz·es
1. To make free from live bacteria or other microorganisms.

2.
 by a non-aldehyde chemical process that is patent pending.

Structural deterioration or degeneration of tissue valves has been a key factor in the dysfunction of bioprostheses, to date. Valve calcification calcification /cal·ci·fi·ca·tion/ (kal?si-fi-ka´shun) the deposit of calcium salts in a tissue.

dystrophic calcification
 is one of the largest contributors to the degeneration of bioprosthetic valves. Some publications suggest that the traditional glutaraldehyde-based treatment process of current tissue valves introduces an external chemistry that may play a role in the calcification process.

CarboMedics has developed a bioprosthesis which is treated with a dye-mediated photo-oxidation process (thus the name PhotoFix) that results in collagen crosslink formation, but uses no glutaraldehyde glutaraldehyde /glu·ta·ral·de·hyde/ (gloo?tah-ral´de-hid) a disinfectant used in aqueous solution for sterilization of non-heat–resistant equipment; also used as a tissue fixative for light and electron microscopy.  and does not introduce external chemistry. Preclinical testing has indicated that this valve exhibits no calcification when implanted in highly calcific calcific /cal·cif·ic/ (-ik) forming lime.

calcific

forming lime.
 animal models. Further analysis has demonstrated that the PhotoFix(TM) treatment is biostable exhibiting non-immunogenicity and no cytotoxicity.

CarboMedics, Inc., a company of Sulzermedica, is headquartered in Austin, Texas, and is the world's most fully integrated source of enhanced heart valve technology and a leading manufacturer of Pyrolite(R) Carbon components. The company is comprised of two segments; a proprietary heart valve group and an original equipment manufacturer (OEM (Original Equipment Manufacturer) The rebranding of equipment and selling it. The term initially referred to the company that made the products (the "original" manufacturer), but eventually became widely used to refer to the organization that buys the products and ) specializing in biomaterial research, development and manufacturing.

CarboMedics is one of nine medical device companies that make up Sulzermedica. The partnership of companies focuses on the development of implantable medical devices and biomaterials for the cardiovascular, orthopedic and dental implant markets. Sulzermedica employs 3,600 people worldwide and is owned by Sulzer Limited, which is headquartered in Winterhur, Switzerland.

CONTACT: CarboMedics, Austin
             Perry Barrs, 512/873-3323, or
                          or
             Fellers & Company,
             Stacy Fellers, 512/338-4500


KEYWORDS: TEXAS

INDUSTRY KEYWORD: BIOTECHNOLOGY REPEATS: New York 212-575-8822 or 800-221-2462; Boston 617-330-5311 or

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COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 6, 1995
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