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8-K - WORLD HEART CORP | v204676_8k.htm |
Exhibit 99.1
Levacor
VAD® Hemocompatibility Analysis Presented at European Mechanical Circulatory
Support Summit
Preservation of an Important Blood
Factor to Prevent Bleeding Observed
Salt Lake City, UT –
December 6, 2010: World Heart Corporation
(WorldHeart; Nasdaq: WHRT), a developer of mechanical circulatory
systems, today announced that an investigator-initiated study that includes
patients who had received the Levacor ventricular assist device (VAD) was the
subject of a presentation in the Emerging New Technologies Section at the Fifth
European Mechanical Circulatory Support Summit. Preliminary clinical
data suggests that the Levacor VAD does not cause acquired von Willebrand Factor
(vWF) deficiency, a condition that is linked to serious bleeding
disorders1
and that has been
associated with the use of current VADs.2
4
“Depletion
of the large protein multimers of the vWF is strongly correlated with bleeding
disorders and bleeding is one of the most prevalent adverse events associated
with the use of VADs,” commented Dr. James W. Long, M.D., Ph.D5,
Director of Advanced Cardiac Care at INTEGRIS Baptist Medical
Center. As he explains, “Shear forces generated within blood pumps
can disrupt the large protein multimer of the vWF, thereby compromising blood
clotting. Any device that avoids disturbing the clotting system like
this could reduce the risk of bleeding complications allowing for expanded use
of VADs for the treatment of heart failure.”
In the
study, von Willebrand multimers were compared in six subjects supported by the
Levacor VAD investigational device with ten subjects who received another
continuous flow rotary pump. Von Willebrand multimers were measured
pre-implant, at various intervals post-implant up to 90 days and after device
removal. In all Levacor VAD recipients, the important large multimer
of the vWF was preserved. In contrast, the large multimers of the vWF
were depleted in all of the other ten recipients. These differences
were statistically significant (p value <0.001).
“The
Levacor VAD was designed using magnetic levitation as an enabling technology to
reduce the shear forces that can cause damage to blood-borne
factors. These data, although preliminary, for the first time suggest
that the Levacor VAD may not cause the same degree of depletion in von
Willebrand Factor as with other continuous flow VAD designs,” said J. Alex
Martin, WorldHeart's President and Chief Executive Officer.
Notes
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1.
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Warkentin TE, Moore
JC, Morgan DG. Aortic stenosis and bleeding gastrointestinal angiodysplasia:
is acquired von Willebrand`s disease the link? Lancet.1992;
340:35-37
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|
2.
|
Meyer
AL, Malehsa D, Bara C, Budde U, Slaughter MS, Haverich A, Strueber M.
Acquired von Willebrand Syndrome in Patients with an Axial Flow Left
Ventricular Assist Device. Circ Heart Fail. 2010;3:6
675-681
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|
3.
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Heilmann
C, Geisen U, Beyersdorf F, Nakamura L, Benk C, Berchtold-Herz
M, Trummer G, Schlensak C, Zieger B. Thromb Haemost 2010; 103:
962–967.
|
|
4.
|
Uriel
N, Pak S, Jorde UP, Jude B, Susen S, Vincentelli A, Ennezat P, CapplemanS,
Naka Y, Mancini D. Acquired von Willebrand Syndrome After Continuous-Flow
Mechanical Device Support Contributes to a High Prevalence of Bleeding
During Long-Term Support and at the Time of Transplantation J
Am Coll Cardiol, 2010; 56:1207-1213
|
|
5.
|
Dr.
Long is a clinical consultant to WorldHeart and this research was
partially supported by an unrestricted
grant.
|
About
the Levacor VAD and World Heart Corporation
The
Levacor VAD is the only fully magnetically levitated, bearingless, implantable
centrifugal pump to move into clinical trials. By using magnetic
levitation to fully suspend a spinning rotor, the Levacor VAD's only moving
part, the pump is designed to eliminate wear and to provide unobstructed
clearances for blood flow across a wide range of operation.
WorldHeart
is a developer of mechanical circulatory support systems based in Salt Lake
City, Utah.
Any
forward-looking statements in this release are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995 and include
all statements relating to WorldHeart's Levacor VAD, including those related to
the degree of depletion in von Willebrand Factor as compared to the current
commercially available VAD, those related to the implants of the Levacor VAD,
and the progress of WorldHeart's clinical development program. Investors are
cautioned that all forward-looking statements involve risk and uncertainties,
including without limitation: risks involved in the clinical trials of the
Levacor VAD; risks in product development, regulatory approvals and market
acceptance of and demand for WorldHeart's products; and other risks detailed in
WorldHeart's filings with the U.S. Securities and Exchange Commission, including
without limitation its Annual Report on Form 10-K for the year ended December
31, 2009 and its Quarterly Reports on Form 10-Q for March 31,
2010, June 30, 2010 and September 30, 2010.
This news
release was distributed by GlobeNewswire, www.globenewswire.com
www.worldheart.com
SOURCE World Heart
Corporation
Mr. Morgan Brown of World Heart
Corporation, +1-801-303-4361