IRVINE, Calif., Feb. 9, 2011—CardiAQ Valve Technologies (CVT), which is developing the world’s first self-conforming and self-anchoring technology for Transcatheter Mitral Valve Implantation (TMVI), today announced that it has appointed Kalathi Thyagarajan, Ph.D., as Vice President of Regulatory Affairs & Quality Assurance, effective immediately.
Most recently, Dr. Thyagarajan was Vice President of Regulatory Affairs & Quality Assurance at CoreValve, which was acquired by Medtronic for $700 million plus milestone payments in April 2009. In that position, Dr. Thyagarajan's responsibilities included managing the definitive international clinical trial for the purpose of seeking regulatory approval in Europe of CoreValve’s system for transcatheter aortic valve implantation (TAVI); certification of the CoreValve facilities; and interaction with the U.S. Food and Drug Administration (FDA).
"Dr. Thyagarajan has a pedigree of achievement in permanent implants, tissue materials, and delivery technologies—both from a regulatory and a research perspective," said Brent Ratz, Co-Founder, President and COO of CardiAQ Valve Technologies. "We are extremely pleased that he has joined CVT as an employee after guiding our regulatory efforts as a consultant during our earliest development phase. As we move toward First-In-Human, his clinical and regulatory skills will be critical to our success."
Prior to CoreValve, Dr. Thyagarajan held senior research-and-regulatory management positions at 3F Therapeutics and VenPro (both cardiac implant start-up environments), the Shiley Heart Valve Research Center and Baxter Healthcare Corp.'s Edwards CVS Division. Earlier in his career, Dr. Thyagarajan was involved in enabling-technology research related to collagen-coated synthetic grafts, biomaterials and biological heart valves. He holds a doctorate degree in biochemistry, and a master's and a bachelor's degree in chemistry.
About CardiAQ Valve Technologies
Privately held CVT, 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 CVT procedure is designed to be performed in a cardiac catheterization laboratory similar to angioplasty or stenting, resulting in less trauma to the patient and substantial cost-savings to the healthcare system.