Cardiac Dimensions has appointed Matthew Stark as vice president of clinical and regulatory affairs, and has also appointed Trevor Moody to its board of directors. According to a press release, Stark is an authority on medical device clinical affairs and brings more than 15 years of experience in clinical study design and oversight to his new role.
Before joining Cardiac Dimensions, Stark served as vice president of clinical and regulatory affairs for Terumo Aortic, formerly Bolton Medical. Prior to his tenure at Terumo Aortic, Stark established and led the medical affairs department for Spectranetics and guided the company through multiple product submissions and approvals. Prior to his time at Spectranetics, Stark managed the clinical study and submission of Gore thoracic stent graft products to the US FDA for approval.
Moody currently serves as managing director at M.H. Carnegie & Co. and has more than 25 years of experience in medical technology, including roles in product development, marketing, management consulting, and venture capital investing.
Speaking about both appointments, Gregory Casciaro, Cardiac Dimensions’ president and CEO comments: “We are thrilled to have Matthew and Trevor join our team as they both have deep experience working with medical device companies at our current stage. Matthew’s experience in leading clinical studies and bringing products to market will play a key role as we build our portfolio of clinical data demonstrating the benefits of the Carillon System in providing a viable treatment option for patients with functional mitral regurgitation. It is an exciting time for Matthew and Trevor to be joining as we anticipate revealing the results of the landmark REDUCE FMR trial by the end of the year, and significantly increasing enrolment in the pivotal CARILLON Trial over the next several months, bringing us closer to submission for FDA approval.”
The press release reports that Cardiac Dimensions’ Carillon mitral contour system is a minimally invasive treatment designed to treat the stretched mitral annulus, the underlying mechanical problem of functional mitral regurgitation. It adds that, unlike other mitral regurgitation therapies, the Carillon system is designed to replicate traditional surgical standards through a catheter-based alternative to medications and invasive surgery.