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News Release
FOR IMMEDIATE RELEASE
Contact: Ronald Trahan, APR, Ronald Trahan Associates, Inc., +1 508-359-4005, x108
CardiAQ™ Valve Technologies reports cardiovascular medicine
milestone: first-in-human nonsurgical percutaneous
implantation of a bioprosthetic mitral heart valve
Nearly 50% of patients suffering from a diseased mitral heart valve with
severe, symptomatic regurgitation are denied open-heart surgery because
it is considered too risky; in the future, Transcatheter Mitral Valve
Implantation (TMVI) may offer new hope for these patients.
IRVINE, Calif., June 14, 2012—CardiAQ Valve Technologies (CardiAQ), which has developed the
world’s first self-conforming and self-anchoring technology for nonsurgical Transcatheter Mitral
Valve Implantation (TMVI), today announced that the Company has achieved a cardiovascular
medicine milestone: a bioprosthetic mitral heart valve was successfully implanted as a compassionate
treatment into an 86-year-old male suffering from severe mitral regurgitation (MR 4+). The
breakthrough TMVI procedure was performed on June 12, 2012, at The Heart Centre, Rigshospitalet
University Hospital, Copenhagen, Denmark, by interventional cardiologists Lars Søndergaard, M.D.,
and Olaf Franzen, M.D., cardiovascular surgeon Susanne Holme, M.D., anesthesiologist Peter Bo
Hansen, M.D., and echocardiographer Nikolaj Ihlemann, M.D.
“Our TMVI system is designed to make nonsurgical mitral heart valve replacement a future alternative
to open-heart surgical replacement and repair,” said Rob Michiels, CEO of CardiAQ Valve
Technologies. “CardiAQ is currently the only transcatheter-transvessel implantation approach to
treating MR. While several companies have been trying to perfect a percutaneous approach to repair
the mitral valve, we believe that such technologies will have a very difficult time demonstrating
sufficient efficacy in treating such a heterogeneous disease,” added Michiels. “CardiAQ’s nonsurgical
valve implantation approach is designed to become a disruptive technology with a much broader
application.”
“CardiAQ has focused on replacement or implantation—not repair—for three reasons: Replacement of
the diseased mitral valve offers (1) the best chance of eliminating regurgitation, (2) the widest
applicability across patient and disease variations, and (3) can be made into a simple, fast,
straightforward interventional—i.e., nonsurgical—procedure,” said Brent Ratz, co-founder and COO.
“As cardiac surgeons, we are taught that residual mitral regurgitation will only lead to more mitral
regurgitation and progressive symptoms. That is why we have focused our efforts on developing a
replacement technology with the potential to eliminate clinically significant MR, not just reduce it,”
said Arshad Quadri, M.D., chairman, founder/inventor and CMO of CardiAQ. “Moreover, many of
these inoperable patients suffer from functional MR, which is actually a result of ventricular dilatation.
CardiAQ’s chordal-sparing approach, combined with its unique anchoring system, provides what can
best be described as a ‘face-lift for the heart’ that may also help promote positive remodeling of the
ventricle.”
About CardiAQ Valve Technologies
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary system for Transcatheter
Mitral Valve Implantation (TMVI). Through the combination of a unique anchoring mechanism and a novel
delivery catheter, physicians will be able to accurately and securely implant a new mitral valve within a beating
heart, thus avoiding open-heart surgery. The CardiAQ procedure is designed to be performed in a cardiac
catheterization laboratory or hybrid operating room. Ultimately the procedure will be similar to angioplasty or
stenting, resulting in less trauma to the patient and substantial potential cost-savings to the healthcare system.
# # # # #
Caut ion: The CardiAQ™ Valve Technologies System for Transcathet er Mitral
Valve Implantat ion is in the early phases of development. It will not be
available in the USA for clinical trials unt il further not ice and is NOT available
for sale.
FOR IMMEDIATE RELEASE
Contact: Ronald Trahan, APR, Ronald Trahan Associates, Inc., +1 508-359-4005, x108
CardiAQ™ Valve Technologies reports cardiovascular medicine
milestone: first-in-human nonsurgical percutaneous
implantation of a bioprosthetic mitral heart valve
Nearly 50% of patients suffering from a diseased mitral heart valve with
severe, symptomatic regurgitation are denied open-heart surgery because
it is considered too risky; in the future, Transcatheter Mitral Valve
Implantation (TMVI) may offer new hope for these patients.
IRVINE, Calif., June 14, 2012—CardiAQ Valve Technologies (CardiAQ), which has developed the
world’s first self-conforming and self-anchoring technology for nonsurgical Transcatheter Mitral
Valve Implantation (TMVI), today announced that the Company has achieved a cardiovascular
medicine milestone: a bioprosthetic mitral heart valve was successfully implanted as a compassionate
treatment into an 86-year-old male suffering from severe mitral regurgitation (MR 4+). The
breakthrough TMVI procedure was performed on June 12, 2012, at The Heart Centre, Rigshospitalet
University Hospital, Copenhagen, Denmark, by interventional cardiologists Lars Søndergaard, M.D.,
and Olaf Franzen, M.D., cardiovascular surgeon Susanne Holme, M.D., anesthesiologist Peter Bo
Hansen, M.D., and echocardiographer Nikolaj Ihlemann, M.D.
“Our TMVI system is designed to make nonsurgical mitral heart valve replacement a future alternative
to open-heart surgical replacement and repair,” said Rob Michiels, CEO of CardiAQ Valve
Technologies. “CardiAQ is currently the only transcatheter-transvessel implantation approach to
treating MR. While several companies have been trying to perfect a percutaneous approach to repair
the mitral valve, we believe that such technologies will have a very difficult time demonstrating
sufficient efficacy in treating such a heterogeneous disease,” added Michiels. “CardiAQ’s nonsurgical
valve implantation approach is designed to become a disruptive technology with a much broader
application.”
“CardiAQ has focused on replacement or implantation—not repair—for three reasons: Replacement of
the diseased mitral valve offers (1) the best chance of eliminating regurgitation, (2) the widest
applicability across patient and disease variations, and (3) can be made into a simple, fast,
straightforward interventional—i.e., nonsurgical—procedure,” said Brent Ratz, co-founder and COO.
“As cardiac surgeons, we are taught that residual mitral regurgitation will only lead to more mitral
regurgitation and progressive symptoms. That is why we have focused our efforts on developing a
replacement technology with the potential to eliminate clinically significant MR, not just reduce it,”
said Arshad Quadri, M.D., chairman, founder/inventor and CMO of CardiAQ. “Moreover, many of
these inoperable patients suffer from functional MR, which is actually a result of ventricular dilatation.
CardiAQ’s chordal-sparing approach, combined with its unique anchoring system, provides what can
best be described as a ‘face-lift for the heart’ that may also help promote positive remodeling of the
ventricle.”
About CardiAQ Valve Technologies
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary system for Transcatheter
Mitral Valve Implantation (TMVI). Through the combination of a unique anchoring mechanism and a novel
delivery catheter, physicians will be able to accurately and securely implant a new mitral valve within a beating
heart, thus avoiding open-heart surgery. The CardiAQ procedure is designed to be performed in a cardiac
catheterization laboratory or hybrid operating room. Ultimately the procedure will be similar to angioplasty or
stenting, resulting in less trauma to the patient and substantial potential cost-savings to the healthcare system.
# # # # #
Caut ion: The CardiAQ™ Valve Technologies System for Transcathet er Mitral
Valve Implantat ion is in the early phases of development. It will not be
available in the USA for clinical trials unt il further not ice and is NOT available
for sale.
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