The company has appointed Jack Lips as clinical specialist manager and Steven Marmon as clinical trial manager. In these positions, the pair are individually responsible for different aspects of overseeing the current Compassionate Feasibility Study, as well as initiating and managing the multinational CE Mark clinical trial for European marketing approval of its Trans-Femoral (TF) and Trans-Apical (TA) Systems for Transcatheter Mitral Valve Implantation (TMVI).
“The start of our definitive clinical trial for CE Marking will be a very significant milestone for CardiAQ in the process of clinically validating our two TMVI Systems,” said Rob Michiels, CEO of CardiAQ. “I am personally thrilled that Steven and Jack have again elected to join me in the realization of yet another frontier in medicine.”
“We are excited that Jack and Steven have joined our team, and I am confident they will play a key role in sustaining CardiAQ as a leader in Transcatheter Mitral Valve implantation,” said Brent Ratz, co-founder/President/chief operating officer of CardiAQ. “Together, they were instrumental in the multinational expansion of the CoreValve TAVR technology, and we look forward to having them apply their 40 years of collective clinical and medical device experience to help bring CardiAQ’s TMVI technology to patients in need.”
Prior to joining CardiAQ, Lips most recently held similar responsibilities at CoreValve (Medtronic plc). He also served in clinical management roles at St. Jude Medical Inc., Novoste Corporation and InterVentional Technologies Inc. Prior to joining the medical device industry, Lips served in various clinical and supervisory positions at the catheterization laboratory of the Medical Centre De Klokkenberg in Breda, The Netherlands. He is fluent in several languages and holds a nursing certificate from Nursing School St. Ignatius-De Borg in Breda, The Netherlands.
Like his colleague, Marmon most recently held similar responsibilities at CoreValve (Medtronic plc) and served in clinical, sales, and marketing management roles at St. Jude/Daig and InterVentional Technologies. Prior to joining the medical device industry, Marmon served in various clinical and managerial positions at the catheterization laboratory of the East Tennessee Baptist Hospital in Knoxville, Tenn. He maintains Registered Cardiovascular Invasive Specialist, Advanced Cardiac Life Support and EMT credentialing, and holds a B.A in Business Administration from National University in San Diego, Calif.
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a Transcatheter Mitral Valve (TMV) implant that can be delivered through multiple delivery systems, including both Trans-femoral and Trans-apical. Through its anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, physicians can 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.