CardiAQ performs first-in-human Trans-Apical TMVI procedure

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, M.D., echocardiographer Nikolaj Ihlemann, M.D., cardiothoracic surgeons Peter Skov Olsen, M.D., Susanne Holme, M.D., and Arshad Quadri, M.D., and anesthesiologist Peter Bo Hansen, M.D.

"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 2^nd 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, M.D., cardiac surgeon, Founder, and CMO.

"In the past few years, the potential of Transcatheter Mitral Valve Implantation has become increasingly clear. As the first company to utilize the subvalvular apparatus in our attachment method, CardiAQ has set the standard for TMV anchoring," said Brent Ratz, co-founder, President and COO. "With the benefit of our Gen 1 First-in-Human experience in 2012, we have gone on to further optimize our implant, incorporating all that we have learned into our 2^nd Generation TMV technology."

"While the company remains focused on our already proven Trans-Femoral TMVI Delivery System, we viewed the Trans-Apical approach as a relatively simple addition to our product portfolio that would allow us to offer a complete suite of access approaches to the teams of surgeons and interventional cardiologists seeking to treat the many patients suffering from MR," said Rob Michiels, Chief Executive Officer.