CardiAQ™ Valve Technologies reports Successful First-in-Human Trans-Apical implantation of its Second Generation Transcatheter Mitral Valve

IRVINE, Calif., May 20, 2014—CardiAQ Valve Technologies (CardiAQ), which performed the first ever trans-femoral, transcatheter mitral valve implantation procedure in June of 2012 with its self-conforming, self-anchoring implant technology, announced today that it has achieved another milestone in cardiovascular medicine by successfully implanting its second generation transcatheter mitral valve in an 88-year-old female suffering from severe mitral regurgitation (MR 4+) using the company’s newly added trans-apical delivery system. The trans-apical TMVI procedure was performed on May 13, 2014, on compassionate grounds at The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark, by interventional cardiologists Lars Søndergaard, MD, echocardiographer Nikolaj Ihlemann, MD, cardiothoracic surgeons Peter Skov Olsen, MD, Susanne Holme, MD, and Arshad Quadri, MD, and anesthesiologistPeter Bo Hansen, MD.
“We are grateful to have had the opportunity to work with the CardiAQ technology again in order to provide treatment to this patient for whom no other alternatives were available,” said Dr. Lars Søndergaard.  “Based on a number of risk and anatomical factors, neither traditional mitral valve surgery, nor transcatheter repair with MitraClip, were options for this patient.  Through careful review and consideration, we determined that TMVI, using CardiAQ’s 2nd generation transcatheter mitral valve and its new trans-apical delivery system, could offer this patient a chance at a longer and more comfortable life.  The valve was implanted successfully with excellent function.  The patient is recovering uneventfully and already feels a marked reduction in symptoms.”
“CardiAQ’s second generation transcatheter mitral valve (TMV) builds upon the company’s proprietary method for anchoring the implant through leaflet engagement, chordal preservation, and annular attachment, while offering greater durability, improved flow properties, and a novel feature for the prevention of paravalvular leaks,” said Arshad Quadri, MD, cardiac surgeon, Founder, and CMO.
About CardiAQ Valve Technologies
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary transcatheter mitral valve (TMV) Implant that can be delivered through multiple delivery systems, including both trans-femoral and trans-apical. Through its unique anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, physicians will be able to accurately and securely implant a new mitral valve within a beating heart, thus avoiding open-heart surgery. The CardiAQ procedures are designed to be performed in a cardiac catheterization laboratory or hybrid operating room. Ultimately, the procedure will result in less trauma to the patient and substantial potential cost-savings to the healthcare system.
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Caution: The CardiAQ™ Valve Technologies System for transcatheter mitral valve implantation is in the early phases of development.  It will not be available in the USA for clinical trials until further notice