BioGlue(R) Surgical Adhesive is Safe and Effective in Range of Cardiac Surgical Procedures
April 22 2004 - 9:30AM
PR Newswire (US)
BioGlue(R) Surgical Adhesive is Safe and Effective in Range of
Cardiac Surgical Procedures Data shows BioGlue contributes to
improved patient outcomes ATLANTA, April 22 /PRNewswire-FirstCall/
-- CryoLife, Inc., a bio-surgical device and human tissue
processing company, today announced the presentation of clinical
data results supporting positive clinical performance of BioGlue(R)
Surgical Adhesive as a hemostatic adjunct in aortic valve and
proximal aortic surgery. In this single-surgeon consecutive series,
use of BioGlue Surgical Adhesive helped facilitate a minimal
reliance on blood products and a low mortality rate for patients
undergoing complex aortic valve and proximal aortic surgical
procedures. This presentation was one of two studies reporting on
the surgical use of BioGlue presented at the Ninth Aortic Surgery
Symposium in New York, New York. "The results of this study
reinforce the value of incorporating BioGlue as an essential
component of complex cardiac procedures," said John Fehrenbacher,
M.D., cardiothoracic surgeon, Methodist Hospital of Indiana, and
lead study investigator. "Use of this surgical adhesive has proven
to be an effective method of decreasing the risk of bleeding
complications." The single-center study reviewed the results of 92
patients, predominantly male, between the ages of 23 and 85 who had
undergone cardiac surgical procedures including ascending arch
repairs, ascending root repairs and Ross procedures. In all cases,
BioGlue Surgical Adhesive was used as a hemostatic and structural
adjunct to standard surgical methods. Of the 92 patients, 11
patients required no perioperative blood products (12 percent), and
the mortality rate for this series was 2.2 percent. No
device-related complications were observed. There was one incidence
of post-operative pseudoaneurysm (1.1 percent) in a patient who
presented with an acute Type A aortic dissection. Additional
clinical information was presented today by Dr. Fehrenbacher
demonstrating the use of BioGlue Surgical Adhesive during an aortic
homograft implantation, which simplified the surgical procedure and
resulted in an excellent clinical outcome. In this case study, a
72-year old female with aortic insufficiency required replacement
of her aortic valve due to severe aortic stenosis. A 22 mm aortic
homograft was implanted as a full root to provide the patient with
the maximum aortic outflow tract, while the adjunctive application
of BioGlue Surgical Adhesive helped to prevent the intraoperative
bleeding. Postoperatively, the patient had normal valve hemodynamic
function. "The ability of BioGlue to rapidly and effectively
prevent bleeding at the surgical site helped simplify this
procedure and reduce the chances of post- operative complications
for this high-risk patient," said Dr. Fehrenbacher. "Our positive
experience working with BioGlue makes it an integral part of
certain cardiac procedures." "BioGlue has consistently performed
well in the operating room, and as a result we're anticipating a
continued trend of increased use by cardiac and vascular surgeons
this year," said Steven G. Anderson, president and chief executive
officer, CryoLife, Inc. "BioGlue revenue increased by 33% to $27.8
million in 2003 compared to 2002 and we expect revenues to increase
to $32 to $34 million in 2004. Excellent market acceptance and the
anticipated introduction of a new innovative delivery system this
year clearly indicate a very successful future for BioGlue. " About
BioGlue BioGlue Surgical Adhesive is a two-component adhesive
composed of purified bovine serum albumin (BSA), a cow protein, and
a chemical called glutaraldehyde. BioGlue Surgical Adhesive employs
a unique delivery system, incorporating a single pre-filled
cartridge and applicator device, providing the surgeon complete
control of the adhesive at the surgical site. BioGlue begins
creating a flexible mechanical seal independently of the body's
clotting mechanism within 20 to 30 seconds, and reaches its maximum
bonding strength in two minutes. In December 2001, the U.S. Food
and Drug Administration (FDA) approved BioGlue Surgical Adhesive to
be used as an adjunct to standard methods of achieving hemostasis
(such as sutures and staples) in adult patients in open surgical
repair of large vessels such as the aorta, femoral and carotid
arteries. About CryoLife, Inc. Founded in 1984, CryoLife, Inc. is a
leader in the processing and distribution of implantable living
human tissues for use in cardiovascular and vascular surgeries
throughout the United States and Canada. The Company's BioGlue(R)
Surgical Adhesive is FDA approved as an adjunct to sutures and
staples for use in adult patients in open surgical repair of large
vessels and is CE marked in the European Community, and much of
Latin America, and in Canada for use in soft tissue repair and
approved in Australia for use in vascular and pulmonary sealing and
repair. The Company also manufactures the SG Model #100 vascular
graft, which is CE marked for distribution within the European
Community. Statements made in this press release that look forward
in time or that express management's beliefs, expectations or hopes
are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These future events may
not occur as and when expected, if at all, and, together with the
Company's business, are subject to various risks and uncertainties.
These risks and uncertainties include that the use of BioGlue may
not prove to be as effective as the recent study indicates, that
the Company's 2004 BioGlue revenues may not meet its expectations,
that the Company's new BioGlue syringe delivery device may not meet
expectations, that demand for CryoLife preserved tissues may not
return to prior levels, the possibility that the FDA could impose
additional restrictions on the Company's operations, require a
recall, or prevent the Company from processing and distributing
tissues or manufacturing and distributing other products, that the
Company may not have sufficient borrowing or other capital
availability to fund its business, that pending litigation cannot
be settled on terms acceptable to the Company, that the Company may
not have sufficient resources to pay punitive damages which are not
covered by insurance or liabilities in excess of available
insurance, the possibility of severe decreases in the Company's
revenues and working capital, that to the extent the Company does
not have sufficient resources to pay the claims against it, it may
be forced to cease operations or seek protection under applicable
bankruptcy laws, changes in laws and regulations applicable to
CryoLife and other risk factors detailed in CryoLife's Securities
and Exchange Commission filings, including CryoLife's Form 10-K
filing for the year ended December 31, 2003, and the Company's
other SEC filings. The Company does not undertake to update its
forward-looking statements. For additional information about the
company, visit CryoLife's website: http://www.cryolife.com/ .
DATASOURCE: CryoLife, Inc. CONTACT: Joseph T. Schepers, Vice
President of Corporate Communications for CryoLife, Inc.,
+1-770-419-3355 Web site: http://www.cryolife.com/
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